Response Pharmaceuticals has initiated subject enrolment for a Phase II trial of its drug candidate RDX-002, designed to manage weight rebound in patients ceasing treatment with Glucagon-like peptide 1 (GLP-1) agonists.
The drug candidate aims to reduce post-prandial triglyceride levels and improve cardiometabolic risk factors.
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RDX-002 is a potent, selective and gut-specific inhibitor of intestinal microsomal triglyceride transfer protein (iMTP).
By inhibiting iMTP, RDX-002 reduces the absorption of triglycerides and cholesterol post-meal, potentially aiding in weight management and cardiometabolic health. The drug is also being considered for patients on antipsychotic medication.
The double-blind study will assess the efficacy and tolerability of RDX-002 over a 12-week period.
Participants in the trial have previously experienced significant weight loss through GLP-1 agonist drugs but are now discontinuing their use. Data from the study is expected to be released in the second half of 2025.
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By GlobalDataResponse Pharmaceuticals founder and CEO Eric Keller said: “In our initial studies in antipsychotic-induced weight gain (AIWG), RDX-002 has shown promise in counteracting weight gain associated with the use of common anti-psychotics with good initial tolerability.
“We are excited to evaluate its effect in this second and important weight management setting while we continue development for AIWG.”
Having undergone multiple Phase I and II clinical trials, RDX-002 has been administered to 496 healthy subjects and patients for up to 84 days.
The trials have shown promising results, with RDX-002 lowering post-prandial triglyceride and LDL cholesterol levels, as well as contributing to weight reduction.
Additionally, Response Pharmaceuticals will present findings from a proof-of-concept study of the drug at Obesity Week 2024, scheduled for 4 November 2024 in San Antonio.
In April this year, the company revealed that the Phase Ib clinical trial demonstrated positive results for RDX-002.
