US-based biotechnology company Rise Therapeutics has enrolled the first subject in a Phase Ib trial to determine the safety and clinical activity of R-5280, an oral immunotherapy for type 1 diabetes (T1D).
The placebo-controlled, blinded trial aims to assess R-5280 in patients with new onset T1D at multiple sites in the US.
Its primary objective is to determine if R-5280 can prevent the progression of beta islet cell destruction, which is a hallmark of T1D.
A total of 39 participants are planned to be enrolled to evaluate the treatment's clinical activity, with reductions in disease severity and various key biomarkers serving as the trial's primary endpoints.
R-5280 is designed to control immune pathways that contribute to autoimmune diseases.
By influencing immune cell differentiation and inflammatory cytokine production, the drug aims to control inflammation associated with autoimmunity.
In a previous pilot clinical study, it showed potential for improving symptoms of T1D.
Rise Therapeutics president and CEO Gary Fanger said: “With our third drug now in clinical development, we have the opportunity with R-5280 to control another devastating disease using an oral immunotherapy approach.”
T1D is a chronic autoimmune condition in which the pancreas produces little to no insulin, causing high levels of blood sugar.
Typically developing in childhood or adolescence, the condition requires patients to undergo lifelong insulin therapy to manage their blood sugar levels.
It affects around 1.6 million people in the US, with roughly 40,000 US citizens being diagnosed each year.
Earlier this year, Rise Therapeutics enrolled the first subject in its Phase I clinical trial of R-2487, a new oral immunotherapeutic medicine intended to treat rheumatoid arthritis.
The study aims to evaluate R-2487’s pharmacodynamics, safety and clinical activity in rheumatoid arthritis patients.
Up to 36 subjects are due to be enrolled in the trial, which will assess disease severity improvements and use various key biomarker and pharmacodynamic evaluations.
