Rise Therapeutics is actively progressing its pipeline of oral immunotherapies, with multiple candidates currently in Phase 1 clinical trials. These programs target a range of autoimmune and inflammatory conditions, including ulcerative colitis, rheumatoid arthritis, and type 1 diabetes, as well as immune oncology.
R-3750 for Ulcerative Colitis
R-3750 is an oral immune therapy designed to restore immune homeostasis in the intestinal tract, addressing the underlying causes of gastrointestinal inflammatory diseases. The drug enhances gut barrier integrity, a critical factor in effectively treating inflammatory gut diseases. R-3750 targets a key microbiome regulatory pathway known to engage immune effector cells lining the intestinal tract.
The Phase 1 trial (NCT05666960) is a single and repeat dose study evaluating the safety, tolerability, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative colitis. The study aims to enroll up to 36 participants, with clinical activity assessed by improvements in ulcerative colitis disease severity and various biomarker and pharmacodynamic assessments.
R-2487 for Rheumatoid Arthritis
R-2487 is a targeted oral immune therapy that induces T regulatory cell populations. Its unique mechanism of action involves engaging specific immune pathways that regulate tolerance and correct T regulatory deficiencies, reducing inflammatory cytokines that contribute to autoimmune disease. This mechanism is particularly relevant in treating autoimmune conditions like rheumatoid arthritis.
The Phase 1 trial (NCT05961592) employs a two-stage enrollment strategy to evaluate both single and repeat dosing, assessing the safety, drug exposure, and clinical activity of R-2487 in patients with mild to moderate rheumatoid arthritis. The study plans to enroll up to 36 participants, with clinical activity measured by improvements in disease severity and a select subset of key biomarker and pharmacodynamic assessments.
R-5280 for Type 1 Diabetes
R-5280 is an oral immunotherapy focused on modulating immune pathways that lead to autoimmune disease. This candidate is designed to selectively engage the immune system to control inflammation by influencing immune cell differentiation and inflammatory cytokine production. Previous clinical studies have shown R-5280 to improve symptoms of type 1 diabetes.
Rise Therapeutics has initiated a double-blind, placebo-controlled clinical trial (NCT06057454) to evaluate the safety, efficacy, and biomarker responses of R-5280 in newly diagnosed type 1 diabetes patients. The clinical study will enroll 39 participants to assess the effects of 12-week oral administration of R-5280.
R-5780 for Cancer
R-5780 is an orally delivered immune oncology drug candidate that engages immune pathways for cancer treatment. R-5780 has demonstrated a pronounced ability to enhance immune checkpoint activity. This drug candidate builds upon the growing understanding of the mechanisms by which the microbiome can promote the efficacy of immune oncology drugs. R-5780 is a targeted drug product that engages selective immune pathways that can drive robust anti-tumor responses.
