Press release
Vertex Announces Positive Results From Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy
– Treatment with the NaV1.8 inhibitor VX-548 led to statistically significant and clinically meaningful reduction in the primary endpoint of change from
About this update from Vertex Pharmaceuticals Incorporated
[{"type":"text","content":"\n– Treatment with the NaV1.8 inhibitor VX-548 led to statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the Numeric Pain Rating Scale (NPRS) –\n\n\n– VX-548 was generally well tolerated –\n\n\n– Vertex plans to advance VX-548 into pivotal development in diabetic peripheral neuropathic pain following discussions with regulators –\n\n\n– VX-548 Phase 2 study in patients with painful lumbosacral radiculopathy, another type of peripheral neuropathic pain, has initiated –\n\n\n– Vertex to host investor call December 13 at 8:00 a.m. ET –\n\n\n BOSTON--(BUSINESS WIRE)--\nVertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN). Treatment with all doses of VX-548 resulted in a statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the weekly average of daily pain intensity on a Numeric Pain Rating Scale (NPRS) at Week 12. The study also included an active reference arm of pregabalin to support the evaluation of the VX-548 treatment effect.\n\n\nVX-548 was generally well tolerated at all doses tested in the study. Most adverse events (AEs) were mild to moderate and there were no serious adverse events (SAEs) related to VX-548.\n\n\n“We are very pleased with these results which add to the body of safety and efficacy data for VX-548 and provide further validation of the analgesic effects of NaV1.8 inhibitors,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “Given the favorable benefit/risk profile of VX-548 seen in this study, we are working with urgency to advance this investigational non-opioid pain medicine into Phase 3 in painful diabetic neuropathy with the goal of changing the standard of care for neuropathic pain, where treatment options are limited. In addition, our Phase 3 studies of VX-548 in acute pain are on track to read out in the first quarter of 2024.”\n\n\n“I am excited by the results from the VX-548 Phase 2 DPN study, which demonstrate a promising safety and efficacy profile and represent a significant milestone in pain management,” said Roy Freeman, M....