Response Pharmaceuticals has completed enrolment in a Phase 2 trial evaluating the company’s drug candidate, RDX-002, for post-GLP-1 weight rebound. The study is assessing the effect of RDX-002, an investigational first-in-class inhibitor of intestinal microsomal triglyceride transfer protein (iMTP), on post-prandial triglyceride levels as well as body weight and other cardiometabolic risk factors in individuals discontinuing the GLP-1 agonists, semaglutide or tirzepatide, for the treatment of obesity.
The trial is a double-blind study evaluating the efficacy and tolerability of RDX-002 over 12 weeks in patients who have lost significant weight using GLP-1 agonist drugs but are planning to discontinue the treatment. RDX-002 is an investigational first-in-class, potent, selective, and gut-specific small molecule inhibitor of intestinal microsomal triglyceride transfer protein (iMTP). The overall effect of iMTP inhibition is a decrease in the amount of triglycerides - and therefore calories - and cholesterol delivered to the body after a meal.
RDX-002 is being developed as a therapy to combat drug-induced weight gain and decrease cardiometabolic risk, including in patients taking life-saving anti-psychotic medications and those discontinuing GLP-1 agonists for the treatment of obesity. RDX-002 has been studied in multiple Phase 1 and Phase 2 clinical trials in more than 400 healthy subjects and patients dosed up to 84 days.
In these studies, RDX-002 lowered post-prandial triglyceride levels and circulating levels of low-density lipoprotein cholesterol (LDL-C), and reduced weight. RDX-002 was generally well-tolerated, with adverse events restricted to mostly mild to moderate GI effects. No serious adverse events have been attributed to RDX-002. RDX-002 is being developed under an exclusive world-wide license from Sanofi.
“GLP-1 agonists have been transformative for patients struggling with obesity. However, recent data from several studies (STEP-1, STEP-4, SURMOUNT-4) suggest that following discontinuation of the GLP-1 drugs semaglutide and tirzepatide, most patients rapidly regain much of the weight lost; and with the weight regain, the risk of developing obesity-related comorbidities, such as high blood pressure, cardiovascular disease and Type 2 diabetes, returns,” says Eric Keller, Response Pharmaceuticals’ CEO. “Giving patients a tool to maintain their weight loss and the associated cardiometabolic benefit remains a considerably underserved medical need.”
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