Health Boards
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.
Source: lycera.com
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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