Lexicon’s RELIEF-DPN 1 Phase 2 Study Results of LX9211 Published in Diabetes Care

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) recently announced that their Phase 2 RELIEF-DPN-1 clinical trial results for LX9211, a non-opioid investigational therapy for diabetic peripheral neuropathic pain (DPNP), have been published in Diabetes Care, the journal of the American Diabetes Association. The study revealed that LX9211 offers significant clinical benefits for individuals suffering from DPNP, a condition that currently has limited effective treatment options.

The RELIEF-DPN-1 trial, a proof-of-concept study, evaluated the effects of LX9211 over an 11-week period. This included a six-week double-blind treatment phase and a five-week single-blind safety follow-up phase. The primary efficacy measure was the change in average daily pain score (ADPS) from the baseline to week 6. The study found that participants in the low-dose LX9211 arm experienced notable pain reduction, and the treatment was well tolerated by patients.

Current treatments for DPNP often provide only modest relief, with less than half of patients seeing a 50% reduction in pain severity. Moreover, many existing therapies come with dose-limiting adverse effects, and despite the lack of strong clinical evidence, opioids are frequently used as a first-line treatment, posing significant risks including addiction and death.

Dr. Rodica Pop-Busui of the University of Michigan, lead author of the research paper, stated that LX9211 shows promise as an effective treatment for moderate-to-severe DPNP pain, a major risk factor for mortality in diabetic patients and a leading cause of non-traumatic amputations. The study's positive outcomes indicate a significant advancement in the clinical management of DPNP.

Craig Granowitz, Lexicon’s senior vice president and chief medical officer, expressed gratitude towards the investigators, research teams, and patients involved in the study, emphasizing that their contributions have paved the way for the forthcoming Phase 2b PROGRESS trial, which is currently enrolling participants across the United States.

An abstract from a Lexicon-sponsored study, focusing on the patient-reported burden of DPNP and insights from in-depth patient interviews, will be presented at the 84th Scientific Sessions of the American Diabetes Association.

The research paper, titled “Efficacy and Safety of LX9211 for Relief of Diabetic Peripheral Neuropathic Pain (RELIEF-DPN-1): Results of a Double-blind, Randomized, Placebo-Controlled, Proof-of-Concept Study,” is accessible for detailed study.

Lexicon Pharmaceuticals is dedicated to pioneering transformative medicines through the Genome5000™ program, their genomics target discovery platform. This platform has led to the identification of over 100 protein targets with therapeutic potential across various diseases. The company has successfully launched INPEFA® (sotagliflozin) in the U.S. and continues to develop a promising pipeline of drug candidates for neuropathic pain, diabetes, and other conditions.

LX9211, discovered through Lexicon’s gene science approach, is a selective, investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). Preclinical studies showed that LX9211 effectively penetrates the central nervous system and reduces pain behavior without impacting opioid pathways. The U.S. Food and Drug Administration has granted LX9211 Fast Track designation for DPNP development.

Lexicon Pharmaceuticals continues to make significant strides in the development of innovative therapies aimed at improving patient outcomes and quality of life.