SAN DIEGO, June 8, 2020 /PRNewswire/ -- Neurana Pharmaceuticals, Inc., a biotechnology pharmaceutical company focused on the treatment of neuromuscular conditions, today announced that the first patient has been enrolled in the Phase 1 central nervous effects (CNS) clinical study of tolperisone, a novel skeletal muscle relaxant in development for the treatment of acute and painful muscle spasms without drowsiness or impact on cognititve function.
"The initiation of this clinical study is an important milestone for the company as we anticipate that tolperisone will not impact cognitive function. This is a key benefit of tolperisone as it is a differentiating feature from currently available skeletal muscle relaxants that are known to cause drowsiness and impair cognitive function," shared Randall Kaye, MD, Chief Medical Officer of Neurana Pharmaceuticals. "We are fortunate to work on this clinical study with Gary Kay, Ph.D. who is an expert in the field of cognition and understanding how therapies impact cognition, mood, and psychomotor performance."
Gary Kay, Ph.D., President and Chief Scientific Officer of Cognitive Research Corporation, stated, "We previously conducted a similar Phase 1 driving simulation study. In that study, patients who received tolperisone experienced no impact on driving performance compared to placebo; in contrast, participants who received cyclobenzaprine showed significant impairment compared to placebo. Additionally, on measures of self-reported sleepiness, motivation and driving performance we found no significant effects for tolperisone compared to placebo. On the other hand, following treatment with cyclobenzaprine, participants failed to recognize that their ability to drive had become impaired at a level comparable to a blood alcohol concentration of 0.05%."
The Phase 1 CNS effects study will utilize the expected commercial dose of tolperisone that will be taken into Phase 3 studies. The study is a randomized, 4-period, crossover study in 36 healthy volunteers designed to investigate the effects of tolperisone on measures of drowsiness and cognitive function compared to cyclobenzaprine and placebo. Eligible volunteers will receive tolperisone 200 mg, tolperisone 400 mg (supratherapeutic dose), a positive control - cyclobenzaprine 10 mg, and/or placebo three times a day (TID) over 3 days of dosing per treatment period. Measures of simulated driving performance and sleepiness compared to placebo (single-day, next day residual effect, multiple-day) will be assessed during the course of the study.
Neurana anticipates reporting topline data for the Phase 1 study in the fourth quarter of 2020.
About Neurana Pharmaceuticals, Inc.
Neurana Pharmaceuticals, Inc. is a privately held, clinical-stage, biotechnology pharmaceutical company focused on the treatment of neuromuscular conditions, including acute, painful muscle spasms of the neck and 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, H.I.G. BioHealth Partners, Hale BioPharma Ventures and MagnaSci Ventures to fund the clinical development of tolperisone. For additional information, please visit www.neuranapharma.com.
SOURCE Neurana Pharmaceuticals, Inc.