SAN DIEGO—Neurana Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the treatment of neuromuscular conditions, announced early this morning the completion of a $60 million Series A financing to further develop tolperisone, a novel, patented skeletal muscle relaxant for the treatment of acute, painful muscle spasms and spasticity without sedation. The financing was led by Sofinnova Ventures and included participation from New Leaf Venture Partners, H.I.G. BioHealth Partners, Longitude Capital and MagnaSci Ventures.
According to Neurana’s website, “Tolperisone is a novel therapeutic compound that has been shown in clinical studies to be safe and effective in the treatment of significant musculoskeletal conditions, including neuromuscular spasms and spasticity. Through wide commercial usage and clinical studies, it has been shown that tolperisone is non-sedating, a key differentiating feature from products that are currently marketed in the US, including cyclobenzaprine.”
Tolperisone is approved and widely used in Europe and Asia for the treatment of neuromuscular conditions, and it has been shown to treat these conditions without sedating patients. It has not been available in the U.S. due to an impurity that was higher than ICH Guidelines. Neurana has an exclusive license from Sanochemia AG to develop and commercialize a patented composition of tolperisone which meets ICH Guidelines in North America.
In Neurana’s recently announced clinical driving simulation study, designed to measure the sedation effects of tolperisone in comparison to cyclobenzaprine (Flexeril), the leading treatment for acute muscle spasms, and placebo in healthy volunteers. Using both objective and subjective measures, tolperisone demonstrated a sedation effect equivalent to placebo, while cyclobenzaprine demonstrated significant impairment, correlating to a blood alcohol content of greater than 0.05.
“Approximately 65 million prescriptions are written each year for the treatment of acute, painful muscle spasms. However, all approved treatment options have been shown to be sedating in both clinical trials and routine clinical usage,” said David F. Hale, Chairman and Interim President & CEO of Neurana. “These sedating effects impact the personal and professional lives of patients, affecting their ability to function and potentially impairing their ability to drive a vehicle when taking skeletal muscle relaxants to treat acute, painful muscle spasms. We believe that tolperisone’s potential to treat neuromuscular conditions without sedation addresses a significant unmet medical need. We are gratified by the support of this experienced group of investors as we seek to treat and improve the quality of life for patients with acute, painful muscle spasms and spasticity.”
Neurana Pharmaceuticals plans to commence a Phase 2 dose ranging clinical trial later this year to further demonstrate the safety and efficacy of tolperisone in subjects with acute, painful neuromuscular spasms of the neck and back.
“Tolperisone is a clinical stage product ready to enter Phase 2 clinical trials. The Company has completed a clinical study to confirm the non-sedative properties of tolperisone using a driving simulation study. With the completion of this study, the Company is planning to commence Phase 2 clinical trials, which are expected to be completed within one year,” Neurana’s website notes. “The subsequent Phase 3 clinical program will be a a 2-week trial designed to establish safety and effectiveness in patients with neuromuscular spasms, and is expected to complete within one year. This will serve as the basis for a New Drug Application (NDA) to obtain regulatory approval from the FDA.”
In conjunction with the financing, David Kabakoff, Ph.D. of Sofinnova Ventures; Dan Becker, M.D., Ph.D. of New Leaf Venture Partners; Alex Zisson of H.I.G. BioHealth Partners; and Josh Richardson, M.D. of Longitude Capital have joined David Hale and Brian Dorsey on Neurana’s board of directors.