Nonopioid Drug Candidate Reduces Pain Associated with Diabetic Neuropathy

September 21, 2022
Giuliana Grossi

LX9211 is a potent, orally delivered, selective small molecule inhibitor of adaptor-associated kinase 1 (AAK1).

This week at the International Association for the Study of Pain (IASP) World Congress on Pain 2022 in Toronto, Canada, pivotal data that evaluated novel drug candidate LX9211 was presented by Anand Patel, MD, Chief Medical Officer, Conquest Research, Certified Principal Investigator. The study assessed the effect of the small molecule inhibitor developed by Lexicon Pharmaceuticals to reduce pain without involving the opioid pathway.

The poster presentation revealed the positive primary endpoint data from the phase 2, proof-of-concept study (RELIEF-DPN 1) of LX9211 in painful diabetic neuropathy, as well as the unique trial design, and baseline patient characteristics. Results demonstrated a statistically significant reduction in average daily pain score when compared to placebo after 6 weeks of treatment with the low dose.

Of the 3 treatment groups, those who received the low dose regimen (an initial dose of 100 mg followed by once-daily doses of 10 mg) exhibited the biggest reduction, of 1.39 points, in ADPS score. The high dose regimen (an initial dose of 200 mg followed by once-daily doses of 20 mg) resulted in a difference of 1.27 points.

Both high and low dose intervention groups were compared with the 0.72 reduction point of the placebo group.

Another study evaluating the effect of LX9211 on neuropathic pain (RELIEF-PHN-1) in patients with post-herpetic neuralgia, is anticipated to yield top-line results around the end of 2022, according to Lexicon.

“We are excited to present these findings to the medical and scientific community and expect to communicate additional LX9211 clinical and preclinical data as they become available. Based on these results, we will expeditiously advance the clinical development of LX9211 for the treatment of neuropathic pain, an area of significant unmet clinical need,” Craig Granowitz, MD, Senior Vice President and Chief Medical Officer, Lexicon Pharmaceuticals said in a statement.


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