- The U.S. Phase 2 trial aims to evaluate efficacy and safety of CX11 in doses up to 200 mg and different titration schemes
- The trial is expected to enroll 250 patients to receive treatment over 36 weeks
BERKELEY HEIGHTS, N.J., April 15, 2025 (GLOBE NEWSWIRE) — Corxel Pharmaceuticals Limited (CORXEL), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world, today announced the clearance of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) for a U.S. Phase 2 trial of CX11, an investigational oral once-daily small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA). This randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of CX11 in patients with obesity and overweight conditions in the U.S., with enrollment expected to begin in the second quarter of 2025.
CX11 (also known as “VCT220”), for which CORXEL acquired global ex-China rights from Suzhou Vincentage Pharma Co., Ltd (Vincentage) in December 2024, is a once-daily oral product candidate designed to offer a convenient alternative to injectable GLP-1 treatments. In a previous Phase 2 trial conducted by Vincentage in China, CX11 achieved competitive weight loss with favorable safety and tolerability. CORXEL’s U.S. Phase 2 trial targets to enroll 250 patients, including those with a BMI of ≥30 kg/m² or a BMI of ≥27 kg/m² with at least one weight-related comorbidity, to receive treatment over 36 weeks and to be further monitored over a 2-week follow-up period. Topline data from this trial is expected in the first half of 2026, and if positive, would pave the way for a global Phase 3 development. CORXEL’s partner Vincentage initiated a Phase 3 registrational obesity trial in China in November 2024.
“We are excited to receive the Study May Proceed Letter from the FDA for the U.S. Phase 2 trial of CX11, a critical milestone in our mission to address the global burden of obesity and related cardiometabolic diseases,” said Bo Liang, Senior Vice President, Head of Clinical Development – Metabolic at CORXEL. “Currently approved GLP-1 therapies, while generally effective, often face obstacles such as weekly injections, titration difficulty, side effects and limited tolerability, maintaining weight loss and supply challenges for peptide-based therapies. With once-daily oral administration and promising clinical data, CX11 aims to address these issues, potentially offering a best-in-class convenient oral treatment solution for patients globally.”
About CX11
CX11 is an investigational oral small molecule GLP-1 RA designed to address cardiometabolic conditions, with a primary focus on obese and overweight patients. With global ex-China rights acquired by CORXEL from Vincentage in December 2024, CX11 aims to overcome limitations of current injectable GLP-1 RAs by offering convenient, once-daily oral administration, weight reduction comparable to injectable GLP-1 RAs, favorable tolerability results, scalability and accessibility as a small molecule product candidate. Clinical data from Vincentage’s Phase 2 trial in China demonstrated competitive weight loss with a favorable safety and tolerability profile. CX11 is currently advancing into a U.S. Phase 2 trial by CORXEL and through a Phase 3 registrational trial in China conducted by Vincentage, positioning it as a potential best-in-class oral therapy for management of obesity and overweight conditions.
About CORXEL’s U.S. Phase 2 Clinical Trial for CX11
CX11’s U.S. Phase 2 clinical trial is a randomized, double-blind, placebo-controlled trial, designed to assess the efficacy and safety profile of CX11 in individuals with obesity and overweight in the United States. The trial targets to enroll 250 patients, including those with a BMI of ≥30 kg/m² or a BMI of ≥27 kg/m² with at least one weight-related comorbidity. The trial will feature five treatment arms: four active treatment groups receiving 120 mg, 160 mg, 200 mg with fast titration, 200 mg with slow titration, of CX11, as well as a placebo group. Patients will receive treatment for 36 weeks and will be further monitored over a 2-week follow-up period. Topline data from this trial is expected to be released in the first half of 2026.
About CORXEL
CORXEL is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world. CORXEL is led by an experienced management team that has a strong track record of identifying, in-licensing and developing attractive clinical product candidates directed at validated targets with proven mechanisms of action (MoAs). CORXEL’s diverse portfolio of clinical-stage product candidates has the potential to redefine treatment standards and address key limitations of current therapies for multiple cardiometabolic indications. CORXEL is developing selective small molecule compounds across the cardiometabolic spectrum with the lead product candidate CX11, an oral GLP-1 receptor agonist (GLP-1 RA) for obese and overweight patients, JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke (AIS) and JX09, a highly selective aldosterone synthase inhibitor (ASI) for hypertension.
For further information about CORXEL, please visit www.corxelbio.com