Rise Therapeutics, a clinical-stage biotechnology company, has announced the completion of dose escalation for its R-2487 and R-3750 clinical trials. These trials are now progressing into the dose expansion phase, marking a significant step in the development of oral immunotherapies for rheumatoid arthritis and ulcerative colitis.
The advancement of R-2487 and R-3750 into the expansion enrollment stage underscores the safety profile observed thus far. According to Gary Fanger, President and CEO of Rise Therapeutics, the company is focused on validating its synthetic biology-based drug approach, which leverages natural immune regulatory mechanisms for early disease correction through convenient oral immunotherapy.
R-2487 for Rheumatoid Arthritis
R-2487 is currently being evaluated in a clinical trial (NCT05961592) to assess its safety, pharmacodynamics, and clinical activity in patients with rheumatoid arthritis. This chronic, systemic inflammatory disorder affects up to 0.24% of the global population and as much as 1% of the U.S. population. R-2487 functions by promoting the development of T regulatory (Treg) cells, which can help to restore Treg deficiencies and reduce the inflammatory cytokines that contribute to rheumatoid arthritis.
R-3750 for Ulcerative Colitis
R-3750 is being investigated in a clinical trial (NCT05666960) to determine its safety, pharmacodynamics, and clinical activity in patients with ulcerative colitis. This lifelong condition affects approximately 5 million individuals worldwide, and current treatments often carry risks and debilitating side effects. R-3750 is designed as an immunologically-directed microbiome medication to reduce gut inflammation, enhance intestinal barrier integrity, and foster a healthier microbiome composition.
Both clinical studies are designed to identify novel biomarkers, with the goal of positioning these drugs for early intervention in disease progression, potentially before severe tissue damage occurs. This approach contrasts with traditional infused biologics, offering a potential opportunity to correct the disease earlier.