Rise Therapeutics Announces FDA Clearance of its IND Application to Initiate a Phase 1 Study of an Oral Immunotherapy for the Treatment of Ulcerative Colitis
ROCKVILLE, Md., Jan. 31, 2023 -- Rise Therapeutics, a biopharmaceutical company engaged in developing novel oral synthetic biology medicines, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a Phase 1 clinical trial of its lead program candidate, R-3750.
R-3750 is a synthetic biology-based cellular immunotherapy being developed for the treatment of Inflammatory Bowel Disease (IBD). Optimized for intestinal delivery of a key microbiome-associated immune regulatory molecule, R-3750 is an oral therapy with the potential to treat the underlying immunological basis of gastrointestinal-associated inflammatory diseases. R-3750 leverages Rise Therapeutics' proprietary drug delivery platform to orally deliver 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 be a single and repeat dose study assessing the safety and tolerability, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative. The study will enroll up to 36 participants where clinical activity will be evaluated by improvement in ulcerative colitis disease severity and a variety of key biomarker and pharmacodynamic assessments.
"Receiving IND clearance for R-3750 is an important accomplishment based upon our talented and motivated team at Rise, and we want to express our thanks to the NIH for supporting the research that led us 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," states Gary Fanger, President and CEO of Rise Therapeutics. "After establishing internal GMP manufacturing at Rise for clinical supply of R-3750, we are focusing on clinical execution to move beyond our initial proof-of-concept study, making synthetic biology medicine a reality for patients."
About Rise Therapeutics
Rise Therapeutics is an emerging, privately held company located in Rockville, Maryland which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. Learn more at www.risetherapeutics.com.