Press release
Data From Lexicon’s RELIEF-DPN 1 Phase 2 Study of LX9211 Published Today in Diabetes Care, a Peer-Reviewed Journal of the American Diabetes Association
Clinical trial of LX9211, an investigational non-opioid investigational therapy, demonstrated clinically significant benefits for people with diabetic
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"Clinical trial of LX9211, an investigational non-opioid investigational therapy, demonstrated clinically significant benefits for people with diabetic peripheral neuropathic pain (DPNP) Investigators conclude that clinical outcomes of RELIEF-DPN 1 support commencement of Lexicon’s dose-ranging Phase 2b PROGRESS trial, currently enrolling patients THE WOODLANDS, Texas, June 19, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Diabetes Care, the peer-reviewed journal of the American Diabetes Association, has published a research paper on the company’s Phase 2 RELIEF-DPN-1 clinical trial investigating LX9211 for the treatment of diabetic peripheral neuropathic pain (DPNP). In the proof-of-concept RELIEF-DPN-1 study, the effects of LX9211 were assessed over an 11-week evaluation period, which included a six-week double-blind treatment period and a 5-week single-blind safety follow-up period. The primary efficacy endpoint under evaluation was the change from baseline to week 6 in average daily pain score (ADPS), which was achieved for subjects participating in the low-dose LX9211 arm. Patient reported outcomes were improved in patients treated with LX9211 and LX9211 was generally well tolerated. As noted by the study authors, currently available therapies for DPNP provide only modest pain relief, with fewer than half of individuals achieving 50% reduction in pain severity. Additionally, most people suffering from DPNP experience undesirable, dose-limiting adverse events with existing therapies. And despite a lack of supportive clinical evidence, many people with DPNP continue to be treated with opioids as first-line therapy, leading to very high associated risks and complications, including death. “Results observed in this study show that LX9211 may become an efficacious treatment for moderate-to-severe pain due to DPNP. These findings reflect a promising breakthrough in the clinical management of DPNP, one of the strongest risk factors for mortality in people with diabetes, and the leading cause of non-traumatic amputation,” said Rodica Pop-Busui, MD, PhD, Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, and the lead author of the research paper. “We are grateful to the investigators, their research teams and the peop...