Lexicon Pharmaceuticals, a biopharmaceutical entity dedicated to developing transformative medicines, has finalized the patient enrollment process for their PROGRESS study. This Phase 2b trial evaluates LX9211, an innovative orally-administered selective small molecule inhibitor targeting adaptor-associated kinase 1 (AAK1), specifically for diabetic peripheral neuropathic pain (DPNP).
The research project, surpassing its original target, successfully recruited 494 participants, exceeding expectations by approximately 20 percent, thereby enhancing the study’s statistical power. Lexicon anticipates releasing the initial results from the PROGRESS study in the first quarter of 2025.
“We are delighted with the completion of enrollment for the DPNP study of LX9211, especially since there is a significant demand for innovative, non-opioid treatments,” stated Dr. Craig Granowitz, Lexicon’s Senior VP and CMO. “The overwhelmingly positive response resulted in an enrollment that surpassed projections, eight weeks ahead of schedule. It highlights the urgent need for DPNP solutions, and we are optimistic that this larger participant pool will yield vital insights, inform the design of Phase 3, and reinforce the evidence base for LX9211 in managing neuropathic pain. We eagerly anticipate sharing the top-line findings in early 2025.”
Initiated in December 2023, the study targeted adult diabetic patients—both Type 1 and Type 2—suffering from moderate to severe DPNP. Designed as a placebo-controlled trial, it primarily aims to observe the reduction in the Average Daily Pain Score (ADPS) over eight weeks. Secondary outcomes measure the change in burning pain and pain’s impact on sleep. Participants were allowed to continue a consistent dose of existing DPNP therapies (gabapentin, pregabalin, or duloxetine), ensuring they didn’t withdraw from treatments providing some relief, aligning with how new DPNP treatments will likely be utilized.
Diabetic Peripheral Neuropathic Pain, associated with chronic hyperglycemia, often leads to incapacitating nerve damage, manifesting as pain, numbness, and additional symptoms in extremities. In the US, approximately 20 million individuals experience neuropathic pain, with around 5 million affected by DPNP.
Crafted using Lexicon’s patented gene science methodology, LX9211 functions as a potent, orally administered selective AAK1 inhibitor, identified through Lexicon’s target discovery initiatives as promising for neuropathic pain management. Preclinical findings exhibited its ability to penetrate the central nervous system and lessen pain behaviors in neuropathic models without engaging the opiate pathway. LX9211 has earned Fast Track designation from the US FDA for its development in DPNP treatment.
Lexicon Pharmaceuticals remains committed to pioneering life-changing therapies, leveraging its Genome5000 program—a unique genomics-based target discovery platform—through which nearly 5,000 genes were studied, uncovering over 100 protein targets with significant therapeutic promise across various diseases.