SAN DIEGO, Calif., June 7, 2021 -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced that 500 of its target 1,000 subjects have been enrolled in the Phase 3, RESUME-1 clinical study of tolperisone, a novel, non-opioid, centrally acting muscle relaxant in clinical development for the treatment of symptoms associated with acute and painful muscles spasms of the back.
Randall Kaye, M.D., Chief Medical Officer of Neurana, stated, “We are very pleased with the pace and cadence of enrollment, particularly considering the challenges of the COVID-19 environment. RESUME-1 is the largest clinical study ever conducted in patients with acute and painful muscle spasms of the back, and to initiate such a study during the unparalleled challenges of COVID-19, is not only a testament to the entire team involved, but also to this painful condition, which impacts so many people. Enrolling half of the projected subjects brings us one step closer to potentially providing a novel solution for patients to manage their acute and painful muscle spasms without the drowsiness associated with commonly prescribed medicines.”
The RESUME-1 Study is a 14 day, double-blind, randomized, placebo-controlled Phase 3 clinical study designed to assess the safety and efficacy of tolperisone in 1,000 male and female subjects experiencing back pain due to or associated with muscle spasms of acute onset. The tolperisone group is receiving 50 mg, 100 mg or 200 mg doses administered three times per day (TID) for a total daily dose of 150 mg, 300 mg or 600 mg. The tolperisone doses selected for the RESUME-1 Study are based on positive safety and efficacy results from the Phase 2 STAR Study, in combination with feedback from the U.S. Food and Drug Administration (FDA) at Neurana’s End-of-Phase 2 meeting. The primary endpoint is subject-rated pain “right now” due to acute back spasm using a Numerical Rating Scale (NRS) (0 to 10 scale, from no pain to worst pain imaginable) on Day 14. The study will enroll subjects across approximately 70 clinical sites throughout the United States.
Neurana anticipates reporting top-line data from the Phase 3 RESUME-1 Study in the fourth quarter of 2021.
About Neurana Pharmaceuticals, Inc.
Neurana Pharmaceuticals, Inc. is a privately held, clinical-stage, biotechnology company focused on the treatment of neuromuscular conditions, including acute, painful muscle spasms of the back. The company was founded in 2013 and is based in San Diego. Neurana’s lead development compound is tolperisone, a novel, non-opioid, non-drowsy, non-cognitive impairing treatment, which the company is developing for the large population of patients who experience muscle spasms. In May 2018, Neurana completed a $60 million Series A financing led by Sofinnova Ventures with participation from Longitude Capital, New Leaf Venture Partners and H.I.G. BioHealth Partners to fund the clinical development of tolperisone. For additional information, please visit www.neuranapharma.com.