Lexicon Pharmaceuticals Selects Medidata to Help Advance First Non-Opioid Drug for Neuropathic Pain in Over Two Decades

Medidata’s technology to improve patient experience, accelerate clinical trials, and streamline enrollment process

Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, announced today that it has been selected by Lexicon Pharmaceuticals, Inc. to help advance PROGRESS, a Phase 2b study of LX9211 in diabetic peripheral neuropathic pain (DPNP), with the potential for LX9211 to become the first new, non-opioid drug approved for neuropathic pain in over two decades. Medidata will enable Lexicon to accelerate patient enrollment and clinical trials for Lexicon’s AAK1 inhibitor LX9211, improving the patient experience with a focus on addressing the high, unmet need for chronic neuropathic pain therapies.

Lexicon will utilize Medidata’s Decentralized Clinical Trial (DCT) solutions, incorporating artificial intelligence and automation, to conduct real-time remote monitoring and data capture from patients in a real-world setting, regardless of where the trial participant is along their treatment journey.

“Our innovative technology is transforming how clinical trials are initiated and managed, and ultimately improving patient experience, supporting the development and approval for new treatments faster than ever before,” said Anthony Costello, CEO, Medidata. “We are honored to work with Lexicon to advance this novel therapy for diabetic peripheral neuropathy with the potential to positively impact the lives of patients suffering from this condition.”

According to the Mayo Clinic, diabetic neuropathy is a serious complication of diabetes that can affect as many as 50 percent of patients suffering from this chronic disease. Currently, existing treatments depend on opioids, which can have severe side effects, including addiction, to relieve pain.

“With no new, non-opioid drugs approved for the treatment of neuropathic pain in over two decades, we are excited about the potential for LX9211,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer, Lexicon. “We are at a critical juncture in our efforts to make this medication available to diabetic patients suffering from neuropathic pain, and our partnership with Medidata has been invaluable in advancing this trial expeditiously and enrolling our first patients in the PROGRESS study.”

About Medidata

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 33,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across 2,200+ customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

About Dassault Systèmes

Dassault Systèmes is a catalyst for human progress. We provide business and people with collaborative virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers can redefine the creation, production and life-cycle-management processes of their offer and thus have a meaningful impact to make the world more sustainable. The beauty of the Experience Economy is that it is a human-centered economy for the benefit of all –consumers, patients and citizens. Dassault Systèmes brings value to more than 350,000 customers of all sizes, in all industries, in more than 150 countries. For more information, visit www.3ds.com

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About Lexicon Pharmaceuticals

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.

About LX9211

Discovered using Lexicon’s unique approach to gene science, LX9211 is a potent, orally delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain and identified LX9211 and another development candidate in a neuroscience drug discovery alliance with Bristol-Myers Squibb from which Lexicon holds exclusive development and commercialization rights. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for development in diabetic peripheral neuropathic pain.

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