First-In-Class Oral ATPase Modulator in Randomized Study Designed to Demonstrate Safety and Efficacy

NEW YORK and ANN ARBOR, Mich., December 7, 2016 /PRNewswire/ — 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.

About Psoriasis

Chronic plaque-type psoriasis is an autoimmune disorder that manifests as a chronic inflammatory skin disease. The features of the underlying inflammation are erythema of the skin with associated induration, scaling, and plaque formation, often in the extensor surfaces. Psoriasis is often a debilitating skin disease that is estimated to affect as many as 7.5 million people in the US, with approximately 1.5 to 3 million cases being diagnosed as moderate in nature.

About LYC-30937

LYC-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. Chronically activated, pathogenic T-lymphocytes have unique metabolic features, allowing these cells to be targeted selectively by LYC-30937. 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 ulcerative colitis (UC) and Crohn’s disease.  Moreover, LYC-30937-EC may be able to impact chronically activated, pathogenic lymphocytes that traffic through the human gut before they can migrate to the distal tissue and cause autoimmune diseases such as psoriasis, rheumatoid arthritis, and multiple sclerosis.

About Lycera

Lycera is a biopharmaceutical company developing novel oral immune modulators for the treatment of autoimmune diseases and cancer. Based on successful progress of its world-class R&D platform, including expertise in immune metabolism, cell signaling, and immune cell differentiation, Lycera is commencing multiple clinical programs in 2016. The company is advancing a wholly owned, oral, gut-directed ATPase modulator, designated LYC-30937-EC, for the treatment of autoimmune disease, and has entered Phase 2 clinical studies in patients with ulcerative colitis and in patients with psoriasis. The Company also is progressing oral RORgamma agonists for diverse applications in immuno-oncology. Lycera has an exclusive strategic collaboration with Celgene Corporation to advance Lycera’s proprietary pipeline for cancer and immune-mediated diseases. In addition, Lycera had previously established collaborations with Merck to discover, develop, and commercialize small molecule therapies for autoimmune disorders.

Lycera’s leadership possesses deep experience in drug discovery, development, and commercialization and has established close relationships with renowned thought leaders and clinical researchers worldwide. Lycera was founded in 2006 based on an initial scientific platform in-licensed from the University of Michigan. Lead investors in Lycera include InterWest Partners, ARCH Venture Partners, Clarus Ventures, and EDF Ventures.

 

CONTACT: Justin Jackson, Burns McClellan, 212-213-0006, ext. 327, jjackson@burnsmc.com

SOURCE Lycera Corp.