Lycera has announced the launch of a Phase 2 clinical trial to assess the effectiveness of its lead clinical-stage candidate, LYC-30937-EC (Enteric Coated), as a once daily oral treatment for patients with active ulcerative colitis (UC). The clinical trial is currently recruiting participants.
“The initiation of the Phase 2 clinical trial of LYC-30937-EC is an important milestone in Lycera’s continued progress and is one of several clinical studies we plan to initiate in the second half of 2016 as we build our portfolio of novel immune modulatory treatments,” Paul Sekhri, Lycera’s president and chief executive officer, said in a press release.
“Based upon the results of our preclinical and Phase 1 studies, we believe LYC-30937-EC may possess key advantages for patients, including localized therapy at the site of disease, and the potential for reduced systemic exposure and side effects,” he added.
LYC-30937-EC, a first-in-class, oral, gut-directed ATPase modulator, is designed to selectively target and induce apoptosis (cell death) in disease-causing immune cells (T-lymphocytes), while not affecting normal cells. Chronically activated and pathogenic T-lymphocytes have specific metabolic features that allow them to be targeted selectively by the drug candidate. Based on pre-clinical studies, LYC-30937-EC has therapeutic potential in inflammatory bowel diseases (IBDs) like UC, as well as in other autoimmune diseases.
By being delivered directly to the gastrointestinal tract, LYC-30937-EC also has the potential to avoid global immune suppression and other side effects linked to current systemic treatments for IBD, including those for Crohn’s disease and UC.
The study, called UPSTART (NCT02762500), plans to enroll up to 120 patients, and will assess the efficacy and safety of LYC-30937-EC in people with active UC. More information on this trial, taking place at three sites in North Carolina and Texas, is available on its clinical trials.gov webpage.
In this double-blind, placebo-controlled, and parallel group Phase 2 study, patients will be randomized 1:1 to receive either LYC-30937-EC or placebo. Treatment will be administered for eight weeks, with an additional two-week safety follow-up period. The primary efficacy endpoint will be the proportion of people achieving clinical remission at week 8 using a modified Mayo score (MMS). Safety will be measured over 10 weeks.
All participants will be offered the possibility to continue treatment in a separate, open-label extension study.
“UC can pose a significant burden for patients, with chronic pain, diarrhea, weight loss, and fatigue having a profound negative impact on daily life,” said Peter D.R. Higgins, MD, director of the IBD program at the University of Michigan Health System and a study sub-investigator. “Many patients have disease that is refractory to current drug therapies, leading to surgical intervention in almost a third of patients. New solutions are needed, and I believe LYC-30937-EC represents a novel and promising approach to targeted treatment of the colonic inflammation that is the hallmark of UC.”
Ulcerative colitis is estimated to affect nearly 700,000 people in the United States.