Rockville’s Rise Therapeutics enrolls first Type 1 patient in clinical trial of diabetes drug

Rise Therapeutics, a clinical-stage biotechnology company in Rockville developing novel oral immunotherapeutic medicines, Monday announced it has enrolled its first patient in its R-5280 placebo controlled, blinded, Phase 1b type 1 diabetes clinical trial.

The Phase 1b clinical trial (NCT06057454) is a placebo controlled, blinded clinical trial designed to determine the clinical activity and safety of R-5280 in new onset type 1 diabetes patients. The clinical study is being conducted at multiple sites in the United States. This repeat dose study in patients is meant to determine if R-5280 can block the advancement of beta islet cell destruction. The study will enroll 39 participants where clinical activity will be evaluated by improvement in disease severity and using a variety of key biomarkers.

R-5280 is an oral immunotherapy focused on controlling immune pathways that lead to autoimmune disease. This product candidate has been selectively designed to engage the immune system to control inflammation by influencing immune cell differentiation and inflammatory cytokine production that contribute to autoimmunity. R-5280 has demonstrated improvement of type 1 diabetes symptoms in a previous pilot clinical study.

Type 1 diabetes is a chronic autoimmune condition where the pancreas produces little to no insulin. Without enough insulin, blood sugar levels can become dangerously high. Type 1 diabetes typically develops in childhood or adolescence and patients require lifelong insulin therapy to manage their blood sugar levels and prevent complications.

Approximately 1.6 million people in the United States are affected by type 1 diabetes and close to 40,000 people receive a new diagnosis of type 1 diabetes in the U.S each year.