Lycera Corp., a biopharmaceutical company developing breakthrough immunomodulatory medicines to treat autoimmune diseases and cancer, has initiated 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 programme 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 programme and anticipate the completion of the study by year end 2015."