Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines,  announced that it has completed dose escalation enrollment stages for both its R-2487 and R-3750 clinical trials. Both studies will now initiate the planned dose expansion stages to enroll additional patients at fixed doses.

"The clinical transition of these programs into the expansion enrollment stage is an important milestone highlighting safety for both drugs," states Gary Fanger President and CEO of Rise Therapeutics. "With the emergence of biomarker, pharmacodynamic, and clinical activity datasets from these studies, we are executing on our mission to validate our novel synthetic biology-based drug approach that harnesses natural immune regulatory mechanisms to correct disease early via convenient oral immunotherapy."

R-2487 is being tested in a clinical trial designed to understand safety, pharmacodynamics, and clinical activity in patients suffering from rheumatoid arthritis (NCT05961592). R-3750 is being tested in a clinical trial designed to understand safety, pharmacodynamics, and clinical activity in patients suffering from ulcerative colitis (NCT05666960). Importantly, each clinical study is designed to identify novel biomarkers. The repeat dose studies are positioning these novel drugs to intervene early in disease progression prior to traditional infused biologics therapy affording an opportunity to correct disease prior to severe tissue damage.

About R-3750

Ulcerative colitis is a lifelong disease afflicting 5 million people worldwide, where the few available treatments can have risks and debilitating side effects. R-3750 represents a novel breakthrough to treating this devastating disease and, as an immunologically-directed microbiome medication, reduces gut inflammation, improves intestinal barrier integrity, and directs a more normal microbiome make-up.

About R-2487

Rheumatoid arthritis is a chronic, systemic inflammatory disorder affecting up to 0.24% of the world population, and as much as 1% of the US population. R-2487 works by inducing evolution of specific immune cells called T regulatory (Treg) cells via a novel mechanism of action, resetting Treg deficiencies to reduce inflammatory cytokines that contribute to rheumatoid arthritis.