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, Md., Oct. 19, 2023 /PRNewswire/ -- 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.

About Rise Therapeutics

Rise Therapeutics is an emerging, privately held biotechnology 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. For more information, go to www.risetherapeutics.com.

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SOURCE Rise Therapeutics