Lexicon Pharmaceuticals has initiated dosing in a Phase 1 study of LX9211, an orally-administered small molecule for the treatment of neuropathic pain. LX9211 is a selective inhibitor of AAK1 (adapter-associated kinase), which in preclinical studies demonstrated significant reduction in pain response in a series of pain models and was well-tolerated at and above efficacious doses in animals.
"The successful filing of the IND followed by initiation of the first-in-human clinical study for LX9211 are significant milestones for the company as these events validate our robust preclinical results and bring us closer to demonstrating clinical proof-of-concept for LX9211 in patients with neuropathic pain," said Praveen Tyle, Ph.D., Lexicon's executive vice president, research and development. "Based on animal data, LX9211 has the potential to significantly reduce pain response while offering a novel therapeutic approach to neuropathic pain through inhibition of AAK1. We look forward to producing important early data to guide our future development plans."
The Phase 1 double-blind, placebo-controlled, single ascending dose study for LX9211 is designed to assess the safety, tolerability and pharmacokinetics of LX9211 across nine oral escalating dose levels (5 mg to 300 mg) in healthy volunteers.