Besins Healthcare will license the Muco (μco) intranasal system from Shin Nippon Biomedical Laboratories (SNBL) for delivery of its BHR-310 progesterone powder, which it is developing for the treatment of mild traumatic brain injury (TBI). The SNBL system includes a muco-adhesive drug carrier and a delivery device called the Fit-Lizer.
Besins Chief Development Officer Thomas W. MacAllister commented, “The overwhelming need for a treatment for concussions or mild TBI cannot be overstated. The condition is a huge unmet medical need, especially in theaters of war and on sports fields. Partnering with SNBL will allow us to quickly accelerate our intranasal progesterone research program. They have a tremendous amount of expertise in nasal delivery and the platform we are licensing gives far superior performance than the numerous other approaches we have tried.”
Clinical studies are anticipated to begin in the 3rd quarter of 2013. According to Besins, prec-clinical studies in rats and monkeys demonstrated that intranasal BHR-310 could “deliver clinically meaningful doses of progesterone to the brain.”
SNBL President and CEO Ryoichi Nagata said, “As we have seen in the preclinical phase, we expect that our Muco system will safely deliver therapeutic levels of progesterone, enabling the drug to be used in a broad population of brain injured patients. We are pleased to partner with a company so dedicated to finding a viable treatment for this unmet medical condition. Establishment of this relationship is another important milestone in using Muco System to provide intranasal solutions to biopharmaceutical products. With its versatility to deliver different types of compounds, we expect that there will be many more partnerships to follow.”
A US company, Prevacus, is also developing an intranasal drug for the treatment of TBI.
Read the Besins press release.