NeuroHealing Pharmaceuticals was founded in 2004 with an unusual mission and out-of-the-box business model. It scours the vast world of approved drugs for molecules that can be reformulated and then repositioned as therapies to treat diseases of the central nervous system. And it does so with only four full-time employees, because NeuroHealing is a “virtual” company—it outsources everything from basic research to clinical trials.
Now, the Newton, MA-based outfit can point to some compelling evidence that its approach is working. In May, NeuroHealing began a pivotal phase 2/3 study of NH001, its drug to treat patients who have fallen into comas following severe traumatic brain injuries. The study is partially funded by a grant from the FDA and has been initiated at the Spaulding Rehabilitation Hospital at Harvard.
NH001 is the first of three drug candidates that NeuroHealing is advancing through the research process. CEO Neal Farber, a veteran of Biogen and several startups, says he was looking for a way to improve the rehabilitation process for patients with brain injuries. “When people suffer those injuries, it isn’t the neurons that are broken, but the connections between them,” he explains.
Some scientific literature suggested that boosting dopamine levels in the brain might help repair those connections. So Farber and his small team started by scouring the globe for a dopamine product that could be used in brain-injury patients. They settled on apomorphine, a drug developed in the 1980s in Europe to treat Parkinson’s Disease. Apomorphine never found much of a market, because it has to be injected, making it less appealing than oral drugs to treat Parkinson’s. NeuroHealing tweaked the drug so it could be safely injected into coma patients as a continuous infusion for 12 hours a day. “We believe that if we keep [dopamine] levels high for a prolonged length of time, we can kickstart neuroplasticity,” Farber says.
In an early trial with eight patients, seven regained consciousness—a success rate that Farber hopes will be repeated in the new trial, which will include 76 patients. If it works, the market opportunity could be rich: There are about 200,000 patients in comas at any given time, according to NeuroHealing’s market research. But there are no … Next Page »
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