Benzinga | Sep 4, 2020 08:03AM EDT

Lexicon Pharmaceuticals Announces Commencement Of Patient Dosing In RELIEF-DPN-1 Phase 2 Clinical Study of LX9211 In Patients With Diabetic Peripheral Neuropathic Pain

THE WOODLANDS, Texas, Sept. 04, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the commencement of patient dosing with blinded study drug in RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. LX9211 is a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).

"We are pleased to progress with patient dosing in our first proof-of-concept study of LX9211, in patients with diabetic peripheral neuropathic pain," said Praveen Tyle, Ph.D., executive vice president of research and development. "Based on preclinical data, we believe that LX9211 has the potential to significantly reduce pain response without addictive properties while offering a novel therapeutic approach to neuropathic pain through inhibition of AAK1. We are preparing for an additional Phase 2 study in post-herpetic neuralgia that is expected to commence later this year and are evaluating opportunities in other areas of neuropathic pain, based on promising results in multiple preclinical models and a favorable Phase 1 clinical safety profile."

About the RELIEF-DPN-1 Study

RELIEF-DPN-1 is a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of diabetic peripheral neuropathic pain. The study is designed to enroll approximately 300 patients at approximately 30 U.S. clinical sites. The primary efficacy endpoint under evaluation is the change from baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS).

About LX9211

LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.