Rise Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for R-3750, an oral immunotherapy designed for the treatment of ulcerative colitis. This clearance paves the way for a Phase 1 clinical trial to evaluate the safety, tolerability, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative colitis.
R-3750 is a synthetic biology-based cellular immunotherapy optimized for intestinal delivery of a key microbiome-associated immune regulatory molecule. The oral therapy aims to treat the underlying immunological basis of gastrointestinal-associated inflammatory diseases. Rise Therapeutics' proprietary drug delivery platform enables targeted biological therapy that engages a specific receptor expressed on dendritic cells, reducing gut inflammation and improving gut membrane barrier integrity.
The Phase 1 trial will enroll up to 36 participants. Clinical activity will be evaluated by improvements in ulcerative colitis disease severity and a variety of key biomarker and pharmacodynamic assessments. The study will involve single and repeat dose assessments.
"Receiving IND clearance for R-3750 is an important accomplishment," stated Gary Fanger, President and CEO of Rise Therapeutics. He also acknowledged the NIH for supporting the research leading to this milestone. "This application brings us one step closer to revolutionizing how we treat debilitating diseases like IBD with targeted oral therapy that leverages natural microbiome pathways to reeducate immunological repertoires treating the root cause of disease."
Rise Therapeutics has established internal GMP manufacturing for the clinical supply of R-3750 and is now focusing on clinical execution to advance synthetic biology medicine for patients.
