Response Pharmaceuticals reveals positive results of RDX-002 in post-GLP-1 management

Response Pharmaceuticals has announced positive top-line results from its double-blind, placebo-controlled Phase 2 clinical trial evaluating RDX-002 in individuals who have previously completed a course of GLP-1 receptor agonist therapy for obesity.

“GLP-1 Receptor Agonist therapies have revolutionized obesity treatment, but they are not the end of the story,” said Professor Chris Packard, Institute of Cardiovascular and Medical Sciences, University of Glasgow. “Many people regain weight and experience the return of an adverse cardiometabolic profile after stopping GLP-1RA therapy. A novel treatment that can sustain and build upon the gains achieved with GLP-1 receptor agonists presents a potentially important advance in long-term obesity care.”

RDX-002, an investigational agent that is a selective inhibitor of intestinal microsomal triglyceride transfer protein (iMTP) - a critical chaperone protein involved in the intestinal absorption of dietary triglycerides and cholesterol - demonstrated statistically significant reductions in blood fat-levels after eating (post-prandial triglycerides) and an associated reduction in weight regain versus placebo over 12 weeks of treatment.

While GLP-1 receptor agonist therapies have advanced the treatment of obesity, multiple analyses have shown that most people discontinue treatment by 12 months, often due to cost or tolerability. As a result, many individuals face challenges maintaining their weight loss and the accompanying metabolic benefits, highlighting a critical unmet need in the post-GLP-1RA setting.

The study enrolled 68 participants at a single US site, evaluating the safety, efficacy, and metabolic impact of RDX-002 monotherapy in a post-GLP-1 setting. Key results from the Phase 2 trial revealed:

• Mean reduction of –227.3 mg*hr/dL in postprandial triglycerides (area under the response curve) at Week 12 versus placebo change of +64.1 mg*hr/ml (LS mean difference of -93.5%; p<0.001)

• Individuals receiving RDX-002 gained less weight after GLP-1 discontinuation: -2.92% (-34% relative difference) versus placebo (p=0.019); exploratory analyses also suggest a corresponding difference in total body fat mass change (mean percent change at week 12 of 1.99% for RDX-002 vs. 6.71% for placebo).

• Improved markers of cardiometabolic health, including blood pressure and high-sensitivity C-reactive protein (hsCRP)

• Favourable safety and tolerability profile consistent with prior studies with no serious adverse events (SAEs) or discontinuations and mild to moderate gastrointestinal AEs that generally resolved early in treatment

• Sustained efficacy in individuals recently completing GLP-1 receptor agonist therapy over 12 weeks, which will be further confirmed with an ongoing 24-week open label extension (OLE)

“These Phase 2 results underscore the potential of our approach to address the most critical gap in obesity care following GLP-1 therapy,” said Response Pharmaceuticals’ Chief Executive Officer, Eric Keller. “By targeting key pathways involved in metabolic regulation, we aim to provide a durable, well-tolerated solution that supports long-term weight management and cardiometabolic health. We remain committed to advancing the development of RDX-002 in our lead indication - antipsychotic-induced weight gain (AIWG) - targeting a highly metabolically vulnerable population, as well as exploring its potential in other areas with significant unmet metabolic need.”

Full data from this Phase 2 study will be presented at an upcoming scientific meeting. Response Pharmaceuticals plans to further evaluate the safety and efficacy of RDX-002 for the treatment of AIWG, and other weight management indications.