RELIEF-DPN-1 clinical trial : Lexicon Pharmaceuticals has started patient dosing in a phase 2 trial of LX9211 for the treatment of diabetic peripheral neuropathic pain.
According to the Texan biopharma company, LX9211 is an oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).
The RELIEF-DPN-1 clinical trial is a randomized, placebo-controlled, multi-center clinical study that will assess the efficacy, safety, and pharmacokinetics of LX9211. The mid-stage clinical study aims to enroll nearly 300 patients at about 30 US clinical sites.
The primary efficacy endpoint of the LX9211 is the variation from baseline, from Day 1, to week six in Average Daily Pain Score (ADPS), which will be based on the 11-point numerical rating scale (NRS).
Praveen Tyle – Lexicon Pharmaceuticals executive vice president of research and development said: “We are pleased to progress with patient dosing in our first proof-of-concept study of LX9211, in patients with diabetic peripheral neuropathic pain.
“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.”
As per Lexicon Pharmaceuticals, the preclinical studies of LX9211 showed central nervous system penetration and reduction in pain behavior across models of neuropathic pain without impacting opiate pathways. The Texan biopharma company holds exclusive research, development, and commercialization rights to LX9211 and additional compounds acting through AAK1 under an alliance with Bristol-Myers Squibb.