Medidata has been chosen 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, ensuring that new treatments can be developed and approved 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,” stated Costello.

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, MD, PhD, 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,” Granowitz added.