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Medidata has announced it has been selected by Lexicon Pharmaceuticals to help advance the Phase IIb study, PROGRESS (NCT06203002). The dose-ranging, randomized, double-blind trial is evaluating LX9211 in diabetic peripheral neuropathic pain (DPNP), with the potential for it to become the first new, non-opioid drug approved for neuropathic pain in over two decades.1
Lexicon will utilize Medidata’s decentralized clinical trial solutions, which will incorporate artificial intelligence and automation to conduct real-time remote monitoring and data capture from patients in a real-world setting. This will allow Lexicon to accelerate enrollment and improve the overall patient experience.
“Our innovative technology is transforming how clinical trials are initiated and managed, and ultimately improving patient experience, ensuring that new treatments can be developed and approved faster than ever before,” Anthony Costello, CEO, Medidata said in a press release. “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 Lexicon, LX9211 is a potent, orally delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1). In December 2020, Lexicon received Fast Track designation from the FDA for the development of LX9211 in DPNP.2
“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,” Craig Granowitz, MD, PhD, senior vice president and chief medical officer, Lexicon said in the press release. “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.”
References
1. Lexicon Pharmaceuticals Selects Medidata to Help Advance First Non-Opioid Drug for Neuropathic Pain in Over Two Decades. News release. May 29, 2024. Accessed May 29, 2024. https://www.medidata.com/en/about-us/news-and-press/lexicon-pharmaceuticals-selects-medidata-to-help-advance-first-non-opioid-drug-for-neuropathic-pain-in-over-two-decades/
2. Lexicon Pharmaceuticals Receives Fast Track Designation from the FDA for LX9211 for Diabetic Peripheral Neuropathic Pain. News release. December 11, 2020. Accessed May 29, 2024. https://www.lexpharma.com/media-center/news/lexicon-pharmaceuticals-receives-fast-track-designation-from-the-fda-for-lx9211-for-diabetic-peripheral-neuropathic-pain
