SPY072 is an investigational, extended half-life monoclonal antibody targeting TL1A for the potential treatment of psoriatic arthritis.

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Interim results from the Phase 1 trials for SPY072, with data reported as of May 30, 2025, met all Phase 1 objectives, supporting their potential to become next-generation anti-TL1A monotherapies in immune-mediated diseases or as elements of combination therapies. Single doses of up to 1500 mg for SPY072 were well tolerated with no serious adverse events reported, exhibited a prolonged half-life supportive of quarterly or less frequent dosing, and suppressed free TL1A through 20 weeks of follow up available for the lowest dose tested.

SPY072 will be advanced via the newly announced SKYWAY-RD basket trial for three rheumatologic conditions. The SKYWAY-RD study is a Phase 2 basket trial investigating Spyre's improved anti-TL1A as a treatment for RA, PsA, and axSpA and is expected to initiate in Q3 2025.

Sun Pharma is discontinuing clinical trials of SCD-044 for psoriasis and has no further plans for development.

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SCD-044 is a novel orally bioavailable S1P receptor 1 agonist for the treatment of inflammatory diseases such as atopic dermatitis and psoriasis. S1P receptor 1 agonists are promising for the treatment of autoimmune inflammatory diseases as they modulate migration of lymphocytes out of lymphatic tissue.

This results in a decrease of circulating pathogenic lymphocytes, thereby reducing inflammation. A Phase 1 study of SCD-044 was completed in healthy volunteers earlier. This study established clinical proof-of-concept for SCD-044 in terms of its safety and pharmacodynamic effects. Lymphocyte count reduction, a surrogate marker of efficacy for S1P receptor 1 agonists, was observed at all dose levels evaluated.

The phase 2 study did not meet its primary endpoint of 75% improvement in PASI (Psoriasis Area and Severity Index) score (≥PASI75) at Week 16. The Phase 2 randomized, double-blind, placebo-controlled study of SCD-044 included 263 people living with moderate to severe plaque psoriasis.

“While we are disappointed with the top-line results of the clinical trials, we would like to thank all the psoriasis and atopic dermatitis patients, the healthcare professionals and administrators who participated in these pivotal clinical trials,” said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma.

There were no major safety or tolerability concerns with SCD-044 in either the plaque psoriasis or atopic dermatitis studies. Sun Pharma is discontinuing clinical trials of the asset and has no further plans for development of SCD-044. Sun Pharma and its partner, Sun Pharma Advanced Research Company Ltd will evaluate the appropriate next steps for SCD-044.

This British study was undertaken to address gaps left by randomized controlled trials in comparing the effectiveness of IL-23p19 and IL-17 inhibitors, specifically Skyrizi (risankizumab) and Kyntheum / Siliq (brodalumab), against each other in a representative clinical population.

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Background:
Interleukin (IL)-23p19 and IL-17 inhibitors have demonstrated high efficacy for psoriasis in randomized controlled trials, though real-world data, particularly for risankizumab (IL-23p19 inhibitor) and brodalumab (IL-17 receptor (IL-17R) inhibitor), is limited.

Objectives:
To assess drug survival of IL-23p19 and IL-17 inhibitors compared to other biologics for psoriasis.

Methods:
We conducted a cohort study using data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) from November 2007 to June 2023. Multivariable flexible parametric models assessed drug survival, with discontinuation due to ineffectiveness and adverse effects reported separately. The primary outcome measure was the absolute difference in restricted mean survival time at 2 years, referred to as adjusted survival time, between all comparators.

Results:
Among 19,034 treatment courses (median follow-up: 2.3 years), treatments included adalimumab (tumour necrosis factor-alpha (TNF-a) inhibitor, n = 6,815), ustekinumab (IL-12/23p40 inhibitor, n = 5,639), secukinumab (IL-17A inhibitor, n = 3,051), ixekizumab (IL-17A inhibitor, n = 1,072), brodalumab (n = 367), guselkumab (IL-23p19 inhibitor, n = 1,258) and risankizumab (n = 832).
Guselkumab and risankizumab had the highest adjusted survival times (years [interquartile ranges]) for effectiveness (1.93 [1.91–1.95] and 1.93 [1.90–1.96], respectively). Risankizumab had the highest survival for safety (1.94 [1.92–1.96]) followed by guselkumab (1.92 [1.90–1.94]) and ustekinumab (1.92 [1.91–1.93]). Brodalumab showed lower adjusted survival time for effectiveness (1.75 [1.69–1.81]) than most biologics except secukinumab and adalimumab; and similar survival for safety (1.85 [1.81–1.90]) compared to IL-17A inhibitors and adalimumab. In patients with psoriatic arthritis, ustekinumab showed reduced drug survival. Prior biologic exposure was associated with a dose–response reduction in survival which was significantly larger for IL-17 inhibitors.

Conclusions:
Guselkumab and risankizumab have the most favourable drug survival for effectiveness, with comparable safety to ustekinumab, and more favourable than other BADBIR biologics. Longer drug survival may reduce treatment burden by minimizing treatment switches, clinic visits and disease flares, supporting IL-23p19 inhibitors as a practical long-term option for psoriasis.

Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors.

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Innovent Biologics a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical study of picankibart (recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, R&D code: IB112).

This study (NCT06945107) is a multi-center, randomized, double-blind, active-controlled Phase 3 clinical study to evaluate the efficacy and safety of switching to picankibart in plaque psoriasis patients with inadequate response to prior anti-IL-17 monoclonal antibody treatment (sPGA score of ≥ 2 and body surface area [BSA] of ≥3%). This study plans to enroll approximately 310 participants, who will be randomized in a 1:1 ratio to the picankibart treatment group or the continued IL-17 monoclonal antibody treatment group. The primary endpoint is the proportion of participants achieving a static Physician’s Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16.

The results of a Phase 2 study (NCT05970978) showed that switching from other biologics (primarily IL-17 monoclonal antibodies) to picankibart led to a rapid clinical response. The observed efficacy in skin lesion clearance and significant improvements on the quality of life suggest picankibart may possess a best-in-class profile among agents with the same target.

Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases.

This study included a cohort of patients with psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), all treated with subcutaneous Cosentyx (secukinumab) at the dose approved for each indication and observed throughout a 9-year period between 2015 and 2023.

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Secukinumab is a biologic agent known for its durable efficacy in chronic plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Monitoring the safety of secukinumab is a priority to ensure its long-term usage.

We aimed to provide an extended safety assessment of secukinumab treatment in a real-world setting. This bicentric observational study enrolled 332 patients with PsO, PsA and AS who received subcutaneous injections of secukinumab for up to 9 years.

Adverse events (AEs) were reported annually as exposure-adjusted incidence rates (EAIRs) per 100 patient-years (pt-y). The total secukinumab exposure was 1129 pt-y. The retention rate was 73%, with 16 (4.8%) of patients discontinuing due to AEs.

Despite most AEs being reported within the first 2 years, their incidence was low and decreased over time. The EAIR of any AEs was the highest in the initial 6 months (32.72/100 pt-y), followed by year 1 (7.62/100 pt-y), and year 2 of treatment (3.01/100 pt-y). Common AEs included respiratory and urinary tract infections, candidiasis, and diarrhoea.

Secukinumab showed sustained safety over an extended 9-year treatment period, supporting its use for the long-term management of these immune-inflammatory disorders.

Ascletis announces U.S. Food and Drug Administration (FDA) clearance of Investigational New drug IND application for Its oral small molecule IL-17 Inhibitor, ASC50, for the treatment of psoriasis.

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Ascletis Pharma announces the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for a Phase I trial for ASC50 for the treatment of mild-to-moderate plaque psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17 (IL-17), an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis.

Following oral dosing in non-human primates, ASC50 demonstrated higher drug exposure, longer half-life and lower clearance than an oral small molecule IL-17 inhibitor comparator, which is currently in the clinical development. Furthermore, ASC50 demonstrated strong efficacy in a psoriasis animal model. These preclinical data support ASC50 as a potential best-in-class once-daily oral drug candidate for the treatment of psoriasis.

The Phase I clinical trial of ASC50 is a randomized, double-blind, placebo-controlled study and will be conducted at multiple sites in the U.S. Dosing of patients with mild-to-moderate plaque psoriasis is expected to start in the third quarter of 2025.

“We are excited and encouraged by the preclinical data of ASC50 as it is the first oral small molecule drug candidate in immunology arisen from our Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) Platform,” said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, “The IND clearance of ASC50 marks a new milestone for Ascletis in autoimmune and inflammatory diseases. We are continuing to work on differentiated agents including oral drugs and once-monthly or less frequent subcutaneously injectables to address unmet medical needs in multiple key therapeutics areas.”

ORKA-002 is a novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A/F that has the potential to be dosed just two to three times per year in psoriasis (PsO) and psoriatic arthritis (PsA)

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Oruka Therapeutics, a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-002, the Company’s novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A and IL-17F (IL-17A/F).

“With both ORKA-001 and ORKA-002 now in human trials, we are moving quickly to demonstrate the clinical differentiation of both assets,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Bimekizumab is launching extremely well as IL-17A/F has emerged as superior to IL-17A inhibition in several important indications. Uniquely, we could have the best targeting approaches for both IL-23p19 and IL-17A/F, potentially allowing us to offer the ideal regimen to patients through our ORKA-001 and -002 monotherapies and our ORKA-021 sequential combination.”

The ORKA-002 Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and pharmacokinetics (PK) of ORKA-002 in approximately 24 healthy volunteers across three subcutaneous dose cohorts. Oruka expects to share interim data from this study around year end 2025.

Pending data from the Phase 1 trial, Oruka plans to initiate a Phase 2 study of ORKA-002 in moderate-to-severe psoriasis in the first half of 2026. The planned study design will evaluate the safety and efficacy of multiple dose levels and regimens of ORKA-002, with a primary endpoint of PASI 100 at week 16.

“ORKA-002 has the opportunity to become the best antibody in the IL-17 class, which is preferred when treating psoriasis with joint involvement or recalcitrant skin disease, as well as psoriatic arthritis, hidradenitis suppurativa, and beyond,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “With this program now in the clinic, we are one step closer to our goal of offering the most possible freedom from disease to patients with psoriasis and other conditions.”

Arcutis Biotherapeutics have published positive results from a pivotal Phase 3 study evaluating the efficacy and safety of Zoryve (roflumilast) foam 0.3% as a once-daily monotherapy treatment for psoriasis of the scalp and body.

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The study showed that treatment with investigational ZORYVE foam resulted in significant improvements across multiple efficacy endpoints, including the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, as well as key secondary endpoints. The data also show improvement in pruritus (itch) was observed as early as 24 hours after the first application.

These compelling results demonstrate that ZORYVE foam 0.3% may provide rapid and significant relief of plaques anywhere on the body and is well-tolerated according to both investigator and patient-reported assessments. The foam formulation is particularly beneficial for its versatility in treating hair-bearing and non-hair-bearing skin, which could ultimately help patients adhere to their treatment.

A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis (ARRECTOR), was a Phase 3, randomized, double-blinded, vehicle-controlled trial which enrolled 432 adults and adolescents aged 12 years and older with plaque psoriasis affecting the scalp and body, across 49 sites in the United States and Canada.

Significantly greater proportions of individuals treated with ZORYVE foam 0.3% achieved the co-primary efficacy endpoints of S-IGA Success and B-IGA Success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline. At Week 8, 66.4% of individuals treated with ZORYVE foam 0.3% achieved S-IGA success compared to 27.8% for vehicle (P<0.0001). At Week 8, 45.5% of patients treated with ZORYVE foam achieved B-IGA success compared to 20.1% for vehicle (P<0.0001).

Other key findings include:

• ZORYVE foam provided a clinically meaningful improvement in scalp itch. 65.3% of individuals treated with ZORYVE achieved a clinically significant reduction in itch compared to 30.3% of individuals treated with vehicle at Week 8 (P<0.0001) as measured by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Significant improvement was seen in the ZORYVE treatment group as early as Week 2. The data also demonstrated improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS) at Week 8, with 63.1% of those treated with ZORYVE foam 0.3% achieving a ≥ 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle (P<0.0001). Significant improvement was seen in the ZORYVE treatment group as early as Week 2.
  
  
• Importantly, there was a greater improvement in itch observed with ZORYVE within 24 hours after the first application compared to vehicle (as measured by mean SI-NRS change from baseline, relative to vehicle; P=0.0164). This improvement over vehicle within 24 hours after the first application was also observed in body itch (as measured by WI-NRS change from baseline, relative to vehicle; nominal P=0.0094).
  
  
• At Week 8, 70.9% of those treated with ZORYVE foam versus 31.3% treated with vehicle achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) (P<.001), another secondary endpoint.
  
• Similarly, 50.1% of people treated with ZORYVE foam 0.3% achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI-75), a key secondary endpoint, as compared to 16.8% of those treated with vehicle at Week 8 (P<.001).
  

ZORYVE foam was well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar in both active treatment and vehicle arms. The most frequent adverse events in the ZORYVE foam arm (≥1%) included headache, diarrhea, and nausea. Investigator-rated application-site tolerability was similar between ZORYVE and vehicle groups, with investigators reporting no evidence of irritation for at least 99.2% of all patients at all time points. Patient-rated application-site tolerability was also similar between ZORYVE and vehicle with at least 94.4% of patients reporting no or mild sensation on local tolerability assessments at all time points.

This study suggests the protective effect of riboflavin on psoriasis merits further attention.

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Psoriasis is a chronic inflammatory skin disease characterised by oxidative stress in the epidermis. Riboflavin (vitamin B2), an essential vitamin with antioxidant properties, may play a role in modulating this condition.

Using data from three cycles of the National Health and Nutrition Examination Survey (NHANES), we analysed 13 825 U.S. citizens, including 409 (2.96%) cases of psoriasis.

A fully adjusted weighted logistic regression model revealed that psoriasis was associated with decreased riboflavin intake: for each natural-log unit increase in riboflavin intake, the risk of psoriasis decreased by an average of 16% (OR: 0.84, 95% CI: 0.73–0.96). This association was particularly significant among middle-aged and elderly people (> 40 years).

Transcriptome analysis of data series GSE41662 and GSE121212 demonstrated upregulation of riboflavin metabolising genes (SLC52A2, SLC52A3, RFK, FLAD1 and SLC25A32) in psoriatic lesional skin. In an in vitro psoriatic keratinocyte model, riboflavin reduction induced upregulation of inflammatory cytokines, ROS response and delayed keratinisation.

These findings indicate that psoriasis is significantly associated with decreased riboflavin intake, and riboflavin metabolism is activated in psoriasis. The protective effect of riboflavin on psoriasis merits further attention.

This study suggests the findings underscore the importance of considering cardiovascular outcomes when selecting systemic therapies for patients with psoriasis. 

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Background:
Psoriasis is a chronic inflammatory disease with multiple comorbidities, including an increased risk of major adverse cardiovascular events (MACE). There is limited and contradictory evidence comparing the impact of systemic treatments for psoriasis on MACE.

Objectives:
To evaluate the incidence of MACE associated with each systemic treatment used for patients with psoriasis and compare these rates to those observed with methotrexate (MTX).

Methods:
We conducted a prospective cohort study using data from the BIOBADADERM registry. Propensity score matching was used to adjust for baseline differences between treatment groups. We calculated the incidence rate (IR) of MACE for each systemic treatment class, including biologics (anti-TNF, IL-12/23, IL-17 and IL-23 inhibitors), conventional systemic therapies (MTX, cyclosporine, dimethyl fumarate and acitretin) and apremilast (APR). The IR for each group was compared to those observed in patients treated with MTX using Poisson regression models adjusted for potential confounders, with 95% confidence intervals (95% CI). The primary outcome was the adjusted incidence rate ratios (IRR) for MACE between patients receiving MTX and those receiving another systemic treatment.

Results:
We analysed data from 5622 patients, 11,368 treatment cycles and 21,762 person-years (PYs). APR (IRR = 0.17; 95% CI, 0.04–0.70) and IL-17 (IRR = 0.43; 95% CI, 0.20–0.91) were associated with a significant reduction in the risk of MACE compared to MTX. Cyclosporine was associated with an increased risk of MACE (IRR = 3.59; 95% CI, 1.17–10.99) compared to MTX. The remaining systemic psoriasis treatments were not significantly associated with an increased or decreased risk of MACE.

Conclusions
This real-world evidence study indicates a potential association between APR and IL-17 with a lower incidence of MACE, while CYC showed a higher incidence compared to MTX. These findings underscore the importance of considering cardiovascular outcomes when selecting systemic therapies for patients with psoriasis.

This study is the largest single cohort investigation to date examining the clinical symptoms and management of vulval psoriasis.

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Background/Objectives:
To explore the clinical presentation, management and impact on quality of life in women with vulval psoriasis.

Methods:
A retrospective, single-centre cohort study of women was conducted at a large dermatology practice from January 2016 to January 2024. Sequential Vulval Quality of Life Index scores and patient data were systematically collected and recorded in an online patient database. Treatment regimens were individualised and titrated to clinical response.

Results:
The study included a total of 350 patients with vulval psoriasis over an eight-year period. 13.1% of patients required systemic treatment solely for vulval disease. The median VQLI score improved from 18.0 ± 9.4 at baseline to 9.7 ± 7.6 at the end of follow-up (p < 0.0001). All domains showed statistically significant improvements except for ‘Sexual Function’. The domains with the greatest improvement were ‘Future Health Concerns’ (69.2%, p < 0.001), ‘Feelings and Emotions’ (63.4%, p < 0.001) ‘Symptoms’ (58.6%, p < 0.001) and ‘Activities of Daily Living’ (56.8%, p < 0.001).

Conclusions and Relevance:
Vulval psoriasis has a substantial impact on quality of life but remains underdiagnosed and undertreated. While treatment can significantly improve outcomes, issues related to sexual function and relationships often persist. Systemic therapy may be required for a subset of patients with vulval-only disease. Routine assessment and targeted management of vulval involvement are crucial to optimising patient well-being.

This study looked at nail involvement in 2888 Egyptian psoriasis patients.

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Nail involvement in psoriasis was reported in 10%–55% of psoriasis patients. Nail psoriasis treatment can be more challenging than treating skin lesions for lack of adequate absorption of topical agents plus the slower nail turnover.

To study the demographic and clinical characteristics of psoriasis patients with nail involvement compared to psoriasis patients without nail involvement. Retrospective analysis of all patients attending the psoriasis unit between 2015 and 2020 was performed.

Patients with and without nail involvement were compared accordingly. A total of 2888 patients were included in the analysis, 2363 of which had no nail involvement and 525 had clinical involvement of nails (18%). Nail involvement was significantly higher among male patients, smokers, patients with longer disease duration, patients with evidence of psoriatic arthritis and those on metformin.

Patients with nail involvement did not show a significant association with diabetes or the manual nature of occupations. The retrospective nature of the study carries the risk of poor registration and has little control over the potential confounders.

The involvement of nails in psoriasis was associated with severe disease and was a risk factor for other comorbidities including psoriatic arthritis.

In this retrospective study, 121 patients with moderate-to-severe plaque psoriasis treated with Cosentyx (secukinumab), Taltz (ixekizumab), Tremfya (guselkumab), or Skyrizi (risankizumab) were analysed.

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Biologic therapies targeting interleukin (IL)-17 and IL-23 have transformed psoriasis treatment, yet real-world evidence on the impact of age on treatment responses and drug survival is limited.

This study aims to compare early (12/16 weeks), mid term (24 weeks) and long term (52 weeks) Psoriasis Area and Severity Index (PASI) responses and drug survival in psoriasis patients aged < 65 versus ≥ 65 years receiving IL-17 or IL-23 inhibitors. In this retrospective study, 121 patients with moderate-to-severe plaque psoriasis treated with secukinumab, ixekizumab, guselkumab, or risankizumab were analyzed.

Patients were stratified into two age groups (< 65, n = 78; ≥ 65, n = 43). PASI75, PASI90, and PASI < 2 outcomes were assessed at 12/16, 24, and 52 weeks. Drug survival was evaluated via Kaplan–Meier analysis (censoring at 24 months) and Cox regression was used to identify predictors of discontinuation. At 12/16 weeks, the < 65 group achieved significantly higher PASI75 (90.5% vs. 65.1%, p = 0.010), PASI90 (75.7% vs. 32.6%, p = 0.030) and PASI < 2 (55.8% vs. 79.7%, p = 0.006) responses than the ≥ 65 group. At 52 weeks, PASI75, PASI90, and PASI < 2 rates were similar between groups (86.3% vs. 97.5%, p = 0.055; 78% vs. 90%, p = 0.112; 85.1% vs. 92.5%, p = 0.253).

There were no significant differences between IL-17 and IL-23 inhibitors within any age group. Overall drug survival at 24 months was high (79.6% for < 65 and 90.3% for ≥ 65, log-rank p = 0.407), with no difference between biologic classes (mean survival: 21.8 vs. 22.4 months, p = 0.520). In Cox regression, female sex (HR 0.23, p = 0.005) and higher baseline PASI (HR 1.093 per point, p = 0.013) predicted discontinuation, whereas age, biologic class, BMI, and prior biologic use were not significant.

Despite a delayed initial response, older patients achieve long-term PASI outcomes comparable to younger patients when treated with IL-17 and IL-23 inhibitors. Drug survival is similarly excellent across age groups and biologic classes.

These findings support the successful use of modern biologics in elderly psoriasis patients.

VYNE has suspended all screening, enrolment and patient dosing in the Phase 1b trial of VYN202 for psoriasis.

VYN202: Oral BD2-selective BET inhibitor

VYN202 has been designed to achieve class-leading selectivity (BD2 vs. BD1), maximum potency versus BD2 and optimal oral bioavailability. Maximizing on-target potency vs. BD2 and minimizing affinity to BD1 may be the key to optimizing the benefit/risk profile of BET inhibitors for autoimmune diseases.

Target Markets:
Moderate-to-severe plaque psoriasis
Moderate-to-severe rheumatoid arthritis

Focused activity:
VYN202 is believed to be the most potent and BD2-selective BET Inhibitor in clinical development which is designed to improve efficacy and tolerability.

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VYNE Therapeutics today announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company that it placed a clinical hold on the Company’s Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis. The clinical hold determination was made following a recent observation of testicular toxicity in dogs from a non-clinical toxicology study with VYN202.

VYNE has suspended all screening, enrollment and patient dosing in the Phase 1b trial of VYN202 and intends to work diligently with the FDA to resolve the clinical hold as soon as possible. To date, there have been no serious adverse events observed in subjects that have been enrolled in the Phase 1b study.

“While we are disappointed by this unexpected development, the safety and well-being of patients in our studies is our top priority,” said David Domzalski, President and Chief Executive Officer of VYNE. “We intend to work closely with the FDA to address the clinical hold as expeditiously as possible and we plan to provide additional updates pending continued engagement with FDA.”

Comparing the efficacy, safety, and drug survival of biologics in psoriasis patients aged 65 + years with matched controls aged 18–64 years during the first year of treatment.

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Background:
Older people represent an increasing proportion of patients treated with biologics for psoriasis. However, data availability is limited due to the underrepresentation of older patients in clinical trials.

Materials and Methods:
This is a multicentric real-world observational study conducted in dermatology centers in the Czech Republic. It aims to compare the efficacy, safety, and drug survival of biologics in psoriasis patients aged ≥ 65 years with matched controls aged 18–64 years (1:2 ratio) during the first year of treatment. Data were extracted from the prospective BIOREP registry and patient medical records for adverse events (AEs).

Results:
A total of 265 elderly patients and 530 matched controls were included. In both groups, a similar proportion of patients achieved a Psoriasis Area and Severity Index (PASI) ≤ 2 after 14 weeks (67% older vs. 63% younger adults), 26 weeks (71% vs. 76%), and 52 weeks (72% vs. 76%). During the first year of biologic therapy, at least one AE was reported in 108 (41%) older and 214 (40%) younger patients. Serious adverse events (SAEs) were reported in 13 (5%) older and 16 (3%) younger patients. Drug survival during the first year of therapy was lower in older (88%) compared to younger patients (96%), especially in those treated with adalimumab (81% vs. 99%).

Conclusion:
The efficacy of biological treatment was comparable between older and younger patients. Despite older people having more comorbidities, SAEs did not increase in this age group. Nonetheless, the survival rate of older patients was notably lower during the treatment period, especially when adalimumab was administered.

The objectives of this study were to estimate the prevalence of excessive sun exposure (ESE) as a proxy for tanning addiction in patients with moderate-to-severe psoriasis and to identify the factors associated with this behaviour.

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Background:
Tanning addiction is a behavioral addiction characterized by an irrepressible desire for sun or ultraviolet light exposure. It is thought to affect 10% to 25% of the population.

Objectives:
This study aimed to estimate the prevalence of this behavior in patients with moderate-to-severe psoriasis and identify associated factors.

Methods:
A cross-sectional study of baseline data from patients included in the PsoBioTeq cohort between 2012 and 2022. Tanning addiction was approximated by patient-reported excessive sun exposure (ESE), defined by the response “I try to expose myself to the sun as often as possible” to a registry question on current behavior. Factors associated with ESE including clinical characteristics, psoriasis and medical history, and previous treatments were also analyzed.

Results:
Among 3705 patients included in the analysis, 636 (17.2%) reported ESE. In multivariate analysis, being younger (OR 0.97, 95% CI [0.96; 0.97]) and female (OR 1.52, 95% CI [1.20; 1.93]), and having a normal weight (OR 0.57, 95% CI [0.42; 0.77]), intermediate skin phenotype (OR 1.80, 95% CI [1.36; 2.38]), and history of phototherapy (OR 1.53, 95% CI [1.19; 1.96]) were associated with a higher ESE risk, whereas previous ustekinumab treatment (OR 0.40, 95% CI [0.19; 0.84]) was associated with a lower ESE risk.

Conclusions:
The prevalence of ESE in patients with psoriasis was 17% and revealed demographic factors that may help to identify the patient population most risk of ESE behavior. Education about photoprotection and optimal rapid control of psoriasis may be particularly important for this population.

This study looked at the preferences of psoriasis patients when talking to a dermatologist.

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Background/Objective:
Despite supporting guidelines and evidence, teledermatology adoption in Germany is low, also possibly due to a lack of services that reflect patients' preferences. This study investigates these preferences in psoriasis care and the influence of sociodemographic, geographic and disease-related factors.

Methods:
A discrete choice experiment was conducted. The attributes included the two teledermatology modes (live-interactive, store-and-forward), treating physician, possibility to ask questions and acknowledgment of concerns. The opportunity to prefer the standard of care was given. Participants were randomly assigned to two scenarios: consultation for acute flare-ups or follow-up. Conditional logit models were used for analysis.

Results:
Among 221 patients with psoriasis (mean age: 58.9 years, 39.8% female), a general preference for the standard of care was observed (acute: β = −0.86, p = 0.001; follow-up: β = −1.24, p = 0.001). Factors that positively influenced preference for teledermatology were medical care provided by the known physician (acute: β = 0.49, p < 0.001; follow-up: β = 0.51, p < 0.001), the possibility to ask questions (acute: β = 0.35, p < 0.001; follow-up: β = 0.52, p < 0.001) and a very good acknowledgment of patients' concerns (acute: β = 0.48, p < 0.001; follow-up: β = 0.50, p < 0.001). Immediate feedback (<24 h) was crucial in acute consultations (β = 0.51, p < 0.001). No preference for a teledermatology mode was noted in either scenario. In both scenarios, lower privacy concerns and higher technology acceptance positively influenced teledermatology preference. In acute care, current long waiting times, whereas in follow-up care, current regular blood sampling positively influenced the preference for teledermatology.

Conclusion:
Patients with psoriasis generally preferred standard-of-care over teledermatology. However, certain attributes positively influenced their preference for teledermatology, including consultations with their known treating physician, acknowledgment of patient concerns and prompt consultation during acute flare-ups. Adapting services to these preferences could increase the use of teledermatology.

This study looked at liver fibrosis in psoriasis patients treated with Tremfya (guselkumab)

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Psoriasis is associated with comorbidities like metabolic syndrome and nonalcoholic fatty liver disease, increasing the risk of liver fibrosis.

This study evaluated the long-term effects of guselkumab on liver fibrosis in 154 psoriasis patients using the Fibrosis-4 (FIB-4) index, a noninvasive marker of fibrosis, over 3 years.

Patients were stratified by baseline FIB-4 (≥ 1.3 or < 1.3) and age (35–65 years). Mean FIB-4 values remained stable across all subgroups, with no significant changes observed. High-risk patients (FIB-4 ≥ 1.3) showed minor, nonsignificant fluctuations, while low-risk patients (FIB-4 < 1.3) exhibited a mild, age-related upward trend.

Disease duration emerged as a key factor influencing FIB-4, highlighting the importance of early treatment. These findings suggest guselkumab does not contribute to liver fibrosis progression in psoriasis patients.

Further research with advanced methods like imaging or biopsy is needed to confirm the long-term hepatic safety of IL-23 inhibitors like guselkumab.

Scientists at the university of Birmingham have shown that a sequence of just three amino acids may reduce the severity of psoriasis when applied topically in an emollient cream.

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The researchers identified the smallest part of a peptide (small protein) called PEPITEM, which occurs naturally in the body and regulates inflammation.

The study also showed that both PEPITEM and the three amino acid (tripeptide) sequence delivered a significant reduction in the severity of psoriasis, that is comparable to a steroid cream.

In its native state, PEPITEM consists of a chain of 14 amino acids, but in this most recent study, researchers led by Professor Ed Rainger from the University of Birmingham and Professor Francesco Maione from the University of Naples Federico II, looked for, and identified the smallest parts of the PEPITEM molecule that influence immune cells and inflammation in psoriasis.

Work by the Birmingham scientists identified two sequences of three amino acids that showed biological activity comparable to the full-length PEPITEM molecule.

The scientists then optimised these tripeptides to improve their stability in the body, and tested their ability to reduce immune cell activation and migration, which are hallmarks of inflammatory disease. Their findings showed these two sequences had at least the same activity as the original PEPITEM molecule.

They then selected the sequence with the greatest biological activity and researchers from the University of Naples Federico II trialled its effectiveness in psoriasis, using an animal model of disease.

They found that topical application directly to the skin every day for seven days in an emollient cream resulted in a clear reduction in disease compared to untreated animals, and their findings were confirmed using PASI (Psoriasis Area and Severity Index) scoring, which is used in clinical practice to measure the extent and severity of psoriasis.

Importantly, the study also showed that both PEPITEM and the tripeptide sequence reduced the PASI score by 50%, making it comparable to the steroid cream Clobetasol Proprionate 0.05%.

Professor Ed Rainger said: “While there are a number of therapies for psoriasis, there is a clear need for new therapeutic agents that can be used continuously, and without the risk of excessive side effects, to prevent psoriasis flares. Our findings raise the possibility of using PEPITEM derived peptides for the treatment of psoriasis.”

“This study also raises the interesting possibility that PEPITEM derived peptides could be used in combination with other psoriasis therapies, allowing lower dosing for longer durations, for example, a ‘steroid sparing’ approach, to reduce the side effects associated with prolonged use of such agents.”

University of Birmingham Enterprise has filed several patent families related to PEPITEM and the components of the PEPITEM molecule responsible for maintaining a normal immune response.

The research team is now seeking investment, licensing, partnering and/or collaborative research opportunities.