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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, Maryland, January 31st, 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 whose natural role is to control host immune function, R-3750 is an oral therapy that has the potential to treat the underlying immunological basis of gastrointestinal-associated inflammatory disease. 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 inflammation and inducing colonic immune homeostasis. As a result, R-3750 improves gut membrane barrier integrity reestablishing a normal microbiome composition.

 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 incredible accomplishment based upon the 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 all the necessary elements to manufacture clinical supply of our drugs with our internal clinical GMP manufacturing infrastructure at Rise, we are focusing on clinical execution and gathering the data necessary to move beyond our initial proof-of-concept study and make synthetic biology medicine a reality for patients.”

“Our program, R-3750, represents a first-in-class immune regulatory approach for mediating anti-inflammatory effects in the gut and a promising solution for mitigating colitis,” says Christian Furlan Freguia, Senior Vice President of Research at Rise. “We’re excited to advance R-3750 into the clinic and believe this study will pave the path for our growing pipeline of drug candidates.”

 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. Unlike traditional biological therapies which require injection or infusion, Rise Therapeutics’ delivery platform allows simple, convenient, and cost-effective oral capsule delivery of targeted protein therapy. Our drug development focus is driven by new microbiome-related discoveries enabling development of targeted, first-in-class immune modulatory drugs for the treatment of inflammation, autoimmunity, cancer, and infection. In the context of its expertise in synthetic biology medicine, proprietary TPX oral drug delivery platform, and clinical GMP manufacturing capabilities, Rise is creating and rapidly advancing life changing cellular-based medicines to the market. For more information, go to www.risetherapeutics.com.