Response Pharmaceuticals Announces Early Completion of Enrollment of a Phase 2 Study Evaluating RDX-002 Treating Patients Discontinuing GLP-1 Agonists

Audio By Carbonatix

FALLS CHURCH, Va.--(BUSINESS WIRE)--Feb 6, 2025--

Response Pharmaceuticals, Inc., a clinical-stage company focused on weight management and metabolic health in high-risk populations, today announced the early completion of enrollment 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.

“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.”

“Response’s lead investigational candidate, RDX-002, has shown promise in a separate, recently completed Phase 1 study focusing on another drug-induced weight management setting, anti-psychotic induced weight gain (AIWG), making it a strong candidate for evaluation in preventing weight rebound following GLP-1 agonist discontinuation,” Dr. Bill Sasiela, Response Pharmaceuticals’ Chief Medical Officer stated. “The rapid enrollment of this study, which completed 12 months ahead of our projected schedule, exceeded all expectations and reinforces the considerable and growing unmet need associated with post GLP-1 weight rebound given the wide-spread use of these novel weight loss drugs. We look forward to reporting data from this study at the end of the second quarter of 2025 as we prepare for a Phase 2b study in our lead indication, AIWG.”

The trial ( NCT06640972 ) 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.

About RDX-002

RDX-002, Response Pharmaceuticals’ lead candidate, 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 S.A.

About Response Pharmaceuticals

Response Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing treatments for weight management and metabolic health in high-need patient populations, with an initial focus on helping patients taking antipsychotic medications for disabling mental illnesses to combat weight gain and metabolic dysregulation associated with these treatments, and use in patients coming off weight loss drugs to help them maintain their weight loss and the associated cardiometabolic benefits. The company is exploring development in other potential settings in which clinically significant weight gain and/or adverse metabolic changes are prevalent.

For more information, please visit https://www.responsepharmaceuticals.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20250206443806/en/

CONTACT: Press and Investor Contact:

Sabine Bisson

Chief Operating Officer

[email protected]

KEYWORD: VIRGINIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS RESEARCH PHARMACEUTICAL SCIENCE BIOTECHNOLOGY

SOURCE: Response Pharmaceuticals, Inc.

Copyright Business Wire 2025.

PUB: 02/06/2025 08:00 AM/DISC: 02/06/2025 08:00 AM

http://www.businesswire.com/news/home/20250206443806/en