Lexicon Completes Screening in Phase 2B Study of LX9211 for Diabetic Neuropathic Pain

Lexicon Pharmaceuticals, Inc. has announced the completion of screening and expects to complete enrollment ahead of schedule in their Phase 2b clinical trial named PROGRESS. This trial is focused on evaluating LX9211, a potent, selective, orally-administered investigational small molecule inhibitor designed to treat diabetic peripheral neuropathic pain (DPNP). The company has also accelerated its timeline for the release of top-line data, moving the expected date from the second quarter of 2025 to the first quarter of the same year.

Dr. Craig Granowitz, Lexicon's senior vice president and chief medical officer, expressed enthusiasm about the trial's progress, remarking that the swift advancement is promising for the near-term completion of the study. He highlighted the urgent need for new, non-opioid medications to treat neuropathic pain, noting that no such drugs have been approved in over two decades. Dr. Granowitz emphasized the potential impact of LX9211 on the lives of patients suffering from neuropathic pain and extended gratitude to the investigators, study sites, Lexicon's clinical team, and especially the patients for their participation.

The PROGRESS trial began in December 2023 and aims to enroll adult patients diagnosed with either type 1 or type 2 diabetes who experience moderate to severe DPNP. Participants are allowed to continue their existing pain management therapies during the trial. The primary endpoint being measured is the reduction in Average Daily Pain Score (ADPS) over an eight-week period.

Lexicon Pharmaceuticals is a biopharmaceutical company dedicated to developing transformative medicines for patients. The company employs its unique genomics platform, the Genome5000™ program, to identify and investigate the role of nearly 5,000 genes. Through this program, Lexicon has pinpointed over 100 protein targets with significant therapeutic potential across various diseases. The company aims to develop innovative medicines that precisely target these proteins, maximizing therapeutic efficacy and safety. Lexicon has already launched one such medication, INPEFA® (sotagliflozin), in the United States, and is actively developing a pipeline of other promising drug candidates for neuropathic pain, diabetes, and metabolic disorders.

LX9211, discovered through Lexicon’s gene science approach, is a selective inhibitor of adaptor-associated kinase 1 (AAK1). This enzyme was identified during Lexicon's target discovery efforts as a potential therapeutic target for neuropathic pain. Preclinical studies of LX9211 demonstrated its ability to penetrate the central nervous system and reduce pain behavior in models of neuropathic pain without involving opiate pathways. The U.S. Food and Drug Administration (FDA) has granted LX9211 Fast Track designation for the treatment of diabetic peripheral neuropathic pain, underscoring the significant need for new treatment options in this area.

In summary, Lexicon Pharmaceuticals is making significant strides with its Phase 2b trial for LX9211 aimed at treating diabetic peripheral neuropathic pain. The company's innovative approach and accelerated timelines highlight the potential of LX9211 to address a critical unmet medical need for non-opioid pain management therapies.