Response Pharmaceuticals Begins Phase 2 Study of RDX-002 for Patients Stopping GLP-1 Agonists; Presents at Obesity Week

FALLS CHURCH, VA, USA I October 17, 2024

Response Pharmaceuticals, Inc., a clinical-stage company focused on weight management and metabolic health, has initiated the enrollment for its Phase 2 trial. This trial aims to evaluate the company's drug candidate, RDX-002, in countering post-GLP-1 weight rebound. RDX-002 is an investigational inhibitor of intestinal microsomal triglyceride transfer protein (iMTP), and the study will focus on its impact on post-meal triglyceride levels, weight, and other cardiometabolic risk factors in individuals who are discontinuing the use of GLP-1 agonists such as semaglutide or tirzepatide for obesity treatment.

According to Eric Keller, Response Pharmaceuticals’ Founder and CEO, there is a growing unmet need among patients who regain weight after stopping GLP-1 agonists, which negates the cardiometabolic benefits gained during treatment. He highlighted the promising results of RDX-002 in previous studies on antipsychotic-induced weight gain (AIWG) and expressed optimism about its potential in this new context.

Professor Chris Packard from the University of Glasgow emphasized the emerging issue of weight regain and associated cardiometabolic risks when patients stop GLP-1 agonist treatment. He noted that RDX-002 might help minimize weight rebound, providing a smoother transition for patients discontinuing GLP-1 agonists.

Dr. Bill Sasiela, Chief Medical Officer, elaborated on the chronic nature and complexity of obesity, which poses significant cardiovascular and metabolic risks such as hyperlipidemia, insulin resistance, type 2 diabetes, and hypertension. While GLP-1 agonists like semaglutide and tirzepatide have been effective in reducing weight and associated risks, many patients eventually stop taking these drugs. RDX-002 has shown potential in reducing drug-induced weight gain by lowering the absorption of dietary fats in the intestine, thus decreasing caloric intake. This also improves post-meal triglyceride levels, "bad" LDL cholesterol, and glycemic control, which are critical factors in preventing cardiovascular disease and diabetes.

The trial (NCT06640972) is a double-blind study assessing the efficacy and tolerability of RDX-002 over 12 weeks. It targets patients who have significantly lost weight using GLP-1 agonist drugs but plan to discontinue the treatment. Results from this study are anticipated in the latter half of 2025.

Additionally, Response Pharmaceuticals announced the presentation of results from their proof-of-concept study of RDX-002 in antipsychotic-induced weight gain at Obesity Week 2024 in San Antonio on November 4th.

RDX-002 is Response Pharmaceuticals’ leading candidate. It is a potent, selective, and gut-specific small molecule inhibitor of iMTP, aimed at reducing the amount of triglycerides and cholesterol absorbed by the body after meals, thus decreasing calorie intake. RDX-002 is developed to combat drug-induced weight gain and improve cardiometabolic risks, particularly in patients on antipsychotic medications and those discontinuing GLP-1 agonists for obesity treatment. The drug has undergone multiple Phase 1 and Phase 2 clinical trials, involving 496 participants, showing promising results in lowering post-meal triglyceride levels, LDL cholesterol, and weight reduction with generally mild to moderate gastrointestinal side effects. No serious adverse events have been linked to RDX-002.

Response Pharmaceuticals is dedicated to developing treatments for weight management and metabolic health in high-need patient populations, particularly those taking antipsychotic medications. The company aims to address the weight gain and metabolic issues associated with these treatments and is exploring the use of RDX-002 in other settings where significant weight gain and metabolic changes are common.