Lexicon Pharmaceuticals Completes Enrollment for Phase IIb Trial of LX9211 in Diabetic Peripheral Neuropathic Pain

Key Insights

• Lexicon Pharmaceuticals has finished enrolling 494 subjects in its Phase IIb PROGRESS trial, exceeding the initial target by 20%, to evaluate LX9211 for diabetic peripheral neuropathic pain (DPNP).
• The PROGRESS trial is a double-blind, placebo-controlled study assessing the reduction in Average Daily Pain Score (ADPS) at eight weeks as the primary endpoint.
• LX9211, an orally delivered AAK1 inhibitor discovered through Lexicon's gene science approach, has received fast-track designation from the FDA for DPNP treatment.

Lexicon Pharmaceuticals has completed subject enrollment for its Phase IIb PROGRESS trial, evaluating LX9211, a novel adaptor-associated kinase 1 (AAK1) inhibitor, for the treatment of diabetic peripheral neuropathic pain (DPNP). The multicenter trial enrolled 494 subjects, surpassing the initial target by approximately 20%. Top-line data is anticipated in the first quarter of next year.

The double-blind, dose-ranging, randomized, parallel-group, open-label extension trial began in December of last year. The study aims to enroll adult subjects with type 1 or type 2 diabetes who are suffering from moderate to severe DPNP. The primary endpoint is the decrease of the Average Daily Pain Score (ADPS) at eight weeks compared to placebo.

Trial Design and Endpoints

The PROGRESS trial is placebo-controlled, with secondary endpoints including the evaluation of changes in burning pain and sleep interference due to pain. The trial design allows subjects to continue one stable-dose DPNP therapy, reflecting the real-world use of new DPNP drugs.

LX9211: A Novel AAK1 Inhibitor

LX9211 was discovered through Lexicon’s gene science-based approach and is delivered orally. The US Food and Drug Administration (FDA) has granted fast-track status to the therapy for development in treating DPNP.

Management Commentary

Lexicon Pharmaceuticals chief medical officer and senior vice-president Craig Granowitz said, “We are pleased to have completed enrolment for the PROGRESS study of LX9211 in DPNP, a condition for which there is a significant need for new, non-opioid treatment options. The strong interest in this study resulted in enrolment significantly exceeding the target and completion of enrolment eight weeks ahead of schedule, underscoring the urgent demand in DPNP. We are confident that the greater-than-expected enrolled patient population will lead to critical insights, inform our Phase III design, and add to the body of evidence supporting the use of LX911 in treating neuropathic pain, and we look forward to sharing top-line findings from the study early next year.”