Rise Therapeutics, a biotechnology company specializing in the development of novel oral immunotherapeutics, has announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for a Phase 1 clinical trial of R-2487, a potential treatment for rheumatoid arthritis. This marks the second clinical program for Rise Therapeutics, which leverages synthetic biology and its proprietary oral biologics delivery platform.

R-2487 has been engineered to induce regulatory T cells (Tregs) and restore immune balance in patients with autoimmune conditions. It works by educating dendritic cells to redirect immune responses away from inflammation. R-2487 is a cellular immunotherapy designed to address the underlying immunological factors of autoimmune diseases, with a primary focus on rheumatoid arthritis. The therapy has the potential to target the root causes of the disease and potentially reverse its development.

Rise Therapeutics, expressed enthusiasm about the progress: "We are excited to initiate our second clinical program at Rise Therapeutics with the evolution of R-2487. As we expand our clinical development capabilities, our goal is to validate a range of life-saving medications based on our synthetic biology platform technology. We aim to advance oral immunotherapy approaches that not only enhance the delivery of protein-based biologics therapy but also reduce the cost of these crucial immune-regulatory medications. We believe that R-2487 holds significant potential for the treatment of various autoimmune diseases."

The Phase I clinical trial will consist of a single and repeat dose study, focusing on assessing the safety and tolerability of R-2487, as well as evaluating drug exposure and clinical activity in patients with rheumatoid arthritis. The trial will enroll up to 36 participants, and the effectiveness of R-2487 will be measured by improvements in rheumatoid arthritis disease severity, along with various key biomarker and pharmacodynamic assessments.

 

Source: prnewswire.com

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