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UPSTART: Phase 2 Trial of ATPase Modulator Initiated in UC
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Lycera has initiated a phase 2 clinical trial of LYC-30937-Enteric Coated in patients with ulcerative colitis, according to a press release.
LYC-30937-EC (Lycera Corp.) is a once-daily oral ATPase modulator designed to be locally delivered to the GI tract and selectively target and induce apoptosis in disease-causing T-lymphocytes. Preclinical studies have shown the drug candidate has therapeutic potential in inflammatory bowel diseases and other autoimmune diseases, and has the potential to avoid global immune suppression and side effects associated with systemic IBD drugs, according to the press release.
The Ulcerative Colitis Phase 2 Study to Assess Remission by Treatment with LYC-30937-EC (UPSTART) will randomly assign up to 120 patients with active UC to receive the drug or placebo once daily for 8 weeks, with 2 additional weeks of follow-up to evaluate safety. The proportion of patients who achieve clinical remission at week 8 based on a modified Mayo score will serve as the primary endpoint. Patients will be offered to continue treatment in an 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,” Peter D. R. Higgins, MD, PhD, director of the Inflammatory Bowel Disease Program at the University of Michigan Health System, and study investigator, said in the press release. “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.”
Disclosures: Higgins has reported financial ties with Lycera Corp.