Lexicon Pharmaceuticals has completed the enrolment of subjects for the multicentre, Phase IIb PROGRESS trial of the new adaptor-associated kinase 1 (AAK1) inhibitor, LX9211, to treat diabetic peripheral neuropathic pain (DPNP).
The trial has enrolled 494 subjects, surpassing the initial target by approximately 20%. Top-line data is anticipated in the first quarter of next year.
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The double-blind, dose-ranging, randomised, parallel-group, open-label extension trial began in December last year and aims to enrol adult subjects with type 1 or type 2 diabetes who are suffering from moderate to severe DPNP.
It is a placebo-controlled trial, with the primary endpoint being the decrease of the Average Daily Pain Score (ADPS) at eight weeks.
Secondary endpoints include 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.
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By GlobalDataLexicon 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.”
LX9211 was discovered through the company’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.
In May this year, the company chose Medidata to help advance the Phase IIb PROGRESS trial of LX9211.
