Rise Therapeutics’ Post

FDA Clears Rise Therapeutics’ IND Application to Initiate a Phase 1 Clinical Study of Its Novel Oral Immunotherapy for the Treatment of Rheumatoid Arthritis Rockville, Maryland, October 19, 2023 – Rise Therapeutics, a biotechnology company engaged in developing novel oral immunotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a rheumatoid arthritis Phase 1 clinical trial for its program candidate, R-2487. This is Rise Therapeutics’ second clinical program developed using synthetic biology and its proprietary oral biologics delivery platform. Designed specifically to induce regulatory T cells (Tregs) and reset immune balance in patients suffering from autoimmunity, R-2487 works by educating dendritic cells to redirect immune responses away from inflammatory effects. R-2487 is a cellular immunotherapy being developed for the treatment of rheumatoid arthritis, engineered to treat the underlying immunological basis of autoimmune disease. Consequently, R-2487 has the potential to target the root cause of rheumatoid arthritis and reverse the development of this devastating disease.   “We are extremely excited to initiate our second clinical-stage program at Rise Therapeutics with the evolution of R-2487” states Gary Fanger, President and CEO of Rise Therapeutics. “As we grow our clinical development infrastructure, our plan is to clinically validate a series of life-saving medications based upon our synthetic biology platform technology to evolve oral immunotherapy approaches that both improve the ease of delivery of protein-based biologics therapy and reduce the cost of these important immune regulatory-based medicines. We believe R-2487 has the potential to broadly treat autoimmune diseases.” The Phase I clinical trial will be a single and repeat dose study assessing the safety and tolerability, drug exposure, and clinical activity of R-2487 in patients with rheumatoid arthritis. The study will enroll up to 36 participants where the clinical activity of R-2487 will be evaluated by improvement in rheumatoid arthritis disease severity, and by measuring a variety of key biomarker and pharmacodynamic assessments. Press Release: https://lnkd.in/ezr4WSn2