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Nice to see more and more being put into helping us live with psoriasis, it's been a long time coming but these past few years have been encouraging and today the pipeline is still looking healthy. And today we have another positive phase 1 result from Akall for their APK-11 psoriasis topical treatment.
Source: akaalpharma.com
Quote:
(Akaal Pharma), an Australian clinical-stage biopharmaceutical company focused on developing new small molecule drugs for the treatment of inflammatory and autoimmune diseases, today announced the positive results from a randomized, double-blind, placebocontrolled Phase-1 clinical trial of AKP-11, a novel and First-in-Class topical Sphingosine 1- Phosphate receptor-1 (S1P1) modulator for the treatment of mild-to-moderate plaque psoriasis.
In this study, the topical application of AKP-11 to psoriasis patients for 28 days was found to be safe, well tolerated and resulted in a significant reduction in plaque severity. No detectable plasma levels of AKP-11 were found in the pharmacokinetic analysis, which is
attributable to the large therapeutic index of AKP-11.
Although a variety of therapies are available for treating psoriasis, there exists an underserved need for safer and effective topical treatments for long-term use. The Phase 1 clinical data for AKP-11, a topical First-in-Class S1P1 modulator, is very encouraging and
strongly supports our Phase 2 clinical trial in a larger number of patients said Dale Dhanoa, Ph.D., CEO of Akaal Pharma.
Study Details:
The Phase 1 clinical trial was a randomized, double-blind, and placebo-controlled study that involved 16 subjects. This study was conducted in 2 parts, Phase 1A and Phase 1B. AKP-11 or placebo were administered as an ointment to 4 healthy subjects in PART A and extended to 12 psoriasis patients in PART B. The patients were treated once daily with a topical application of AKP-11 for 28 consecutive days. AKP-11 reduced the local psoriasis severity index (LPSI) and demonstrated significant efficacy when compared to baseline (p=0.0016). The placebo group did not show efficacy. No clinically significant local or systemic adverse events were observed in the study.
About AKP-11
AKP-11 is a novel, potent and highly selective sphingosine 1-phosphate receptor subtype-1 (S1P1) modulator undergoing clinical development for topical treatment of psoriasis and other skin diseases. AKP-11, a novel small molecule, has also shown excellent preclinical pharmacokinetic and pharmacodynamics profile as a potential Best-in-Class oral treatment for autoimmune indications. AKP-11 acts via multimodal actions and significantly reduces the overexpression of pro-inflammatory cytokines and factors including the permeability factor VEGF.
Source: akaalpharma.com