Lexicon Pharmaceuticals Chooses Medidata for Non-Opioid Neuropathic Pain Drug

7 June 2024

Medidata Solutions, Inc., a leading provider of clinical trial solutions and a subsidiary of Dassault Systèmes, has been chosen by Lexicon Pharmaceuticals, Inc. to support the advancement of LX9211, a potential non-opioid treatment for diabetic peripheral neuropathic pain (DPNP). The collaboration aims to enhance the Phase 2b PROGRESS study, which evaluates the efficacy of LX9211, potentially becoming the first new non-opioid drug approved for neuropathic pain in over 20 years.

Medidata’s role in this partnership is to facilitate accelerated patient enrollment and streamline the clinical trial processes for Lexicon's AAK1 inhibitor, LX9211. By leveraging Medidata’s Decentralized Clinical Trial (DCT) solutions, which incorporate artificial intelligence and automation, Lexicon can conduct real-time remote monitoring and data capture, irrespective of the patient's location in their treatment journey. This approach aims to improve patient experiences and address the significant unmet need for effective chronic neuropathic pain therapies.

Anthony Costello, CEO of Medidata, highlighted the transformative impact of their technology on clinical trials. He noted that their innovative solutions are revolutionizing how trials are initiated and managed, ultimately expediting the development and approval of new treatments. Costello expressed honor in supporting Lexicon's efforts to advance a novel therapy for diabetic peripheral neuropathy, potentially improving the lives of many patients.

Diabetic neuropathy, as reported by the Mayo Clinic, is a severe complication of diabetes affecting up to 50% of diabetic patients. Current treatments predominantly rely on opioids, which carry risks of severe side effects, including addiction. The development of LX9211, therefore, represents a crucial step forward in providing a safer, non-opioid alternative for treating neuropathic pain.

Craig Granowitz, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Lexicon, expressed excitement about LX9211’s potential. He emphasized the critical stage they are at in making this medication available to diabetic patients suffering from neuropathic pain and acknowledged the invaluable support from Medidata in advancing the trial and enrolling patients efficiently.

Medidata, established 25 years ago, has been at the forefront of technological innovation in clinical trials, with a record of over 33,000 trials and 10 million patients. The company offers a comprehensive, end-to-end platform trusted by more than 1 million registered users across 2,200+ customers, aimed at improving patient experiences and accelerating the development of new therapies. As a Dassault Systèmes brand, Medidata continues to be recognized for its leadership in the industry.

Dassault Systèmes, Medidata’s parent company, focuses on providing collaborative virtual environments through its 3DEXPERIENCE platform, enabling sustainable innovations across various industries. With over 350,000 customers in more than 150 countries, Dassault Systèmes aims to foster human progress through technological advancements.

Lexicon Pharmaceuticals, a biopharmaceutical company, is committed to developing groundbreaking medicines that transform patients’ lives. Utilizing its Genome5000™ program, Lexicon has identified significant therapeutic targets and developed innovative medicines such as INPEFA® (sotagliflozin). The company’s pipeline includes promising drug candidates in various stages of development for neuropathic pain, diabetes, and other indications.

LX9211, discovered through Lexicon’s gene science approach, is an orally administered, selective inhibitor of adaptor-associated kinase 1 (AAK1). It has demonstrated potential in preclinical studies to reduce pain behavior without affecting opioid pathways and has received Fast Track designation from the U.S. Food and Drug Administration for diabetic peripheral neuropathic pain treatment.

In summary, the collaboration between Medidata and Lexicon Pharmaceuticals is set to significantly advance the clinical trial process for LX9211, potentially bringing a much-needed non-opioid treatment option to patients suffering from diabetic peripheral neuropathic pain.

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