US-based biopharmaceutical firm Lycera has started a Phase I clinical trial of LYC-30937, an oral gut-directed ATPase modulator, for the treatment of inflammatory bowel disease (IBD).
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Discovered and developed by Lycera based on technology licensed from the University of Michigan, LYC-30937 is designed to selectively induce cell death (apoptosis) in disease-causing immune cells, sparing normal cells.
The company maintains full worldwide development and commercial rights of the product.
Lycera president and CEO Paul Sekhri said: "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."
In mid-2016, the company intends to begin clinical trials 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.
Lycera chief medical officer Dr Jeffrey Wilkins said: "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.
"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."
Wilkins said that the completion of the study is expected by this year end.