Lycera initiates phase2 trial of LYC-30937-EC for psoriasis

[Fred]

Lycera has announced it has initiated a phase2 trial of LYC-30937-EC for psoriasis. YC-30937, a first-in-class, oral, gut-directed ATPase modulator, is designed to selectively target and induce cell death (apoptosis) in disease-causing immune cells (T-lymphocytes) based on their unique metabolic features, while sparing normal cells.

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Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, announced today the initiation of a Phase 2 clinical trial of the Company’s lead therapeutic candidate, LYC-30937-Enteric Coated, in patients with psoriasis. Psoriasis is often a debilitating skin disease that is estimated to affect as many as 7.5 million people in the United States, with approximately 1.5 – 3 million cases being diagnosed as moderate.  Current systemic therapeutics for the treatment of moderate-to-severe psoriasis result in 75% improvement in the Psoriasis Area Severity Index (PASI) in approximately 80% of patients, but require injections and often lead to side effects, including pronounced immune suppression.  A significant need exists for more convenient, orally dosed psoriasis treatments that provide high PASI scores and low rates of adverse events.

“We continue to make substantial progress with our development of novel immune modulators and are very pleased to have initiated our second Phase 2 clinical trial with our first-in-class ATPase modulator this year. Moreover, this study marks a major accomplishment for the investigation of a gut-directed therapy to target the treatment of peripheral autoimmune disease,” said Paul Sekhri, President and CEO of Lycera. “Based upon the results of our preclinical studies, we believe LYC-30937-EC can impact pathogenic lymphocytes that traffic through the human gastrointestinal tract before these lymphocytes can migrate to distal tissues, such as the skin, causing psoriasis.  If successful, this trial may lead the way to exploring LYC-30937-EC in other diseases, such as rheumatoid arthritis and multiple sclerosis.”

“Psoriasis can pose a significant burden for patients, i.e., chronic itching, stinging, and pain, having a profound negative impact on daily functions and diminished quality of life,” stated Jerry Bagel, M.D., Medical Director for the Psoriasis Treatment Center of Central New Jersey and an investigator in the Phase 2 study. “In addition, many patients experience depression, decreased self-esteem, and anxiety, and new oral therapies would be helpful. I believe LYC-30937-EC represents a unique mechanism of action and a promising approach to targeting the cells that cause inflammation and are the hallmark of psoriasis.”

Lycera’s Phase 2 study UPRISE (gUt-directed LYC-30937-EC study in Psoriasis as oRal treatment for autoImmune diseaSE) is a randomized, double-blind, placebo-controlled parallel group trial designed to assess the efficacy and safety of LYC-30937-EC given orally once daily in subjects with moderate psoriasis. The study is expected to enroll up to 30 patients, randomized on a 2:1 basis to receive either treatment with LYC-30937-EC or placebo. Subjects will be treated for 12 weeks, with an additional 2-week safety follow-up. The primary efficacy endpoint will be the change in mean PASI Score and Investigator global assessment; safety will be measured over 14 weeks.

Source: lycera.com

[jiml]

It's good to see that Lycera are looking at the disease from a different angle, I hope that this oral drug will be successful as it will give dermatologists another weapon in their arsenal to attack this disease

I look forward to seeing the result of this phase 2 trial although it is only on a small number of patients

[Fred]

It's good to see that Lycera are looking at the disease from a different angle, I hope that this oral drug will be successful as it will give dermatologists another weapon in their arsenal to attack this disease

I look forward to seeing the result of this  phase 2 trial  although it is only on a small number of patients  

Little acorns Jim.

[Caroline]

It's good to see that Lycera are looking at the disease from a different angle, I hope that this oral drug will be successful as it will give dermatologists another weapon in their arsenal to attack this disease

I look forward to seeing the result of this  phase 2 trial  although it is only on a small number of patients  

Yes, seemingly it searches for the/certain lymphocytes as the carriers.

[Caroline]

This is an interesting, specifically different, approach.

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ATPase modulator, is designed to selectively target and induce cell death (apoptosis) in disease-causing immune cells (T-lymphocytes), while sparing normal cells. Chronically activated, pathogenic T-lymphocytes have unique metabolic features, allowing these cells to be targeted selectively by LYC-30937. Based on preclinical studies, LYC-30937 has therapeutic potential in inflammatory bowel diseases such as ulcerative colitis as well as in other autoimmune diseases.  Combined with the ability to localize drug delivery to the GI tract, LYC-30937-EC has the potential to avoid global immune suppression and other side effects associated with drugs currently administered systemically to treat inflammatory bowel disease, including UC and Crohn’s disease.

So it points to T-cells and is proven to work for ulcerative collitis.

ATPase itself is

An enzyme that catalyzes the formation of ATP from ADP, inorganic phosphate, and energy, found in mitochondria and chloroplasts; adenosine triphosphatase. Also called ATP synthase.

This as far as I can see related to the energy cycle of the cells, mitochondria.

Very interesting as it points also to other auto immune diseases. Like psoriasis and maybe also MS, might be a nice competitor for Tecfidera.    

P.s. Fred, two times a

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[Fred]

P.s. Fred, two times a

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A nice cup of coffee

[Caroline]

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[Fred]

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Yes and I know it doesn't work for the short version.

The short version I made for quoting outside stuff so we know the difference from our own content.

[D Foster]

Do I read that it doesn't effect the immune system which would be good.

[Caroline]

Do I read that it doesn't effect the immune system which would be good.

It effects the immune system yes, but due to this enzyme trick, it only claims to effect the T-cells that have gone out of pace, it leaves the essential and good T-cells alone.
They have the théorie that the out of pace T-cells cause the psoriasis. It works for more than only one auto immune disease.

To me this seems quite an innovating approach at this moment. But I will start some research on it.
Remember, we don't know the side effects yet.