SAN DIEGO, Calif., December 21, 2020 -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced that the first patient has 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.
“We are excited to enroll the first patient in our Phase 3 RESUME-1 Study,” shared Randall Kaye, MD, Chief Medical Officer of Neurana. “I would like to extend our sincere gratitude to our 70 clinical trial site investigators who will be navigating unprecedented times during COVID-19. It is with the commitment and dedication of this team that we have the potential to provide patients with a novel solution for managing their pain without the drowsiness of commonly prescribed medicines.”
The RESUME-1 Study is a 14 day, double-blind, randomized, placebo-controlled Phase 3 study designed to assess the safety and efficacy of tolperisone in 1,000 male and female patients experiencing back pain due to or associated with muscle spasm of acute onset. The tolperisone group will receive 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 (CLN-201), 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 patients across 70 clinical sites in the United States.
“Patients with acute and painful muscle spasms have been without a treatment option that does not cause sleepiness or drowsiness,” stated Joseph V. Pergolizzi Jr., MD, Chief Operating Officer of NEMA Research, Inc. “The enrollment of the first patient in the tolperisone RESUME-1 Study marks an important milestone towards potentially having a novel solution for patients that will provide relief from pain while enabling them to participate in their daily lives.”
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.