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Lycera Initiates Phase 1 Clinical Trial of LYC-30937, a First-In-Class ATPase Modulator for Inflammatory Bowel Disease.

NEW YORK and ANN ARBOR, Mich., April 30, 2015 /PRNewswire/ -- Lycera Corp., a biopharmaceutical company developing breakthrough immunomodulatory medicines to treat autoimmune diseases and cancer, today announced the initiation of a Phase 1 clinical trial of LYC-30937 in healthy volunteers. LYC-30937 is an oral gut-directed ATPase modulator that is being studied for the treatment of inflammatory bowel disease (IBD). LYC-30937 is designed to selectively induce cell death (apoptosis) in disease-causing immune cells, sparing normal cells. LYC-30937 was discovered and developed by Lycera based on technology licensed from the University of Michigan; the company maintains full worldwide development and commercial rights.

"The initiation of a clinical program for LYC-30937 marks a major milestone for Lycera. This is our first program to enter the clinic, as well as the first ATPase modulator to commence clinical testing," said Paul Sekhri, President and CEO of Lycera Corp. "Lycera is dedicated to advancing a portfolio of drugs based on breakthrough science that have the potential to offer substantial advances for patient treatment. We are proud of the progress of our lead program, and look forward to further accelerating additional candidates in our pipeline." In mid-2016, Lycera expects to initiate clinical studies for its lead immune-oncology product candidate, an agonist of RORgamma, as well as an anti-fibrotic agent, a highly selective ROCK2 (rho-associated kinase II) inhibitor.

"Inflammatory bowel diseases including ulcerative colitis and Crohn's disease, are chronic, life-long autoimmune diseases with significant medical needs and the potential for life-threatening complications," said Dr. H. Jeffrey Wilkins, Chief Medical Officer of Lycera. "In contrast to current injectable treatments, LYC-30937 is an oral agent that acts on a novel target, locally in the gut. Our development plan looks to demonstrate whether the promising preclinical data translates into an effective and well-tolerated novel treatment for patients with ulcerative colitis and inflammatory bowel disease. We are excited to initiate the clinical program and anticipate the completion of the study by year end 2015."

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 2015 and 2016. The company is advancing an oral, gut-directed ATPase modulator, designated LYC-30937, for the treatment of inflammatory bowel disease, which is currently in Phase 1 clinical testing, and oral RORgamma agonists for diverse applications in immune-oncology. In addition, Lycera has established two 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. Lead investors in Lycera include InterWest Partners, ARCH Venture Partners, Clarus Ventures, and EDF Ventures.

CONTACTS:

For Media: Justin Jackson, Burns McClellan, on behalf of Lycera Corp. 212-213-0006, ext. 327 jjackson@burnsmc.com

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SOURCE Lycera Corp.
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