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 drugs approved to treat them. That would offer the company pricing power, which in turn could translate to a market of between $500,000 and $1 billion a year, Farber estimates.
NeuroHealing’s second product candidate required a combination of deep market research and resourcefulness. Farber and his colleagues wanted to develop a drug to address Parkinson’s, so they began asking physicians who treat the disease what the greatest unmet needs were among patients who suffer from it. Much to their surprise, one problem commonly cited was uncontrollable drooling—known by its scientific name as sialorrhea. “It’s a problem that patients are embarrassed to talk about,” Farber says. “We went to Parkinson’s support groups to talk to these patients, and the more research we did, the more we realized they really wanted a therapy to treat this.”
NeuroHealing found a potential remedy for drooling in a most unlikely place: the eye doctor’s office. The company’s experimental product, NH004, is a variation of tropicamide—a drug used for more than 50 years to dilate the pupils of patients prior to eye exams or surgeries. Tropicamide is an “anticholinergic agent,” meaning it blocks certain receptors in the nervous system. As an oral preparation, it blocks the acetylcholine receptors of the salivary glands, thereby providing a potential solution for drooling. NeuroHealing developed and patented a thin-strip technology, and transformed tropicamide into an oral drug that Parkinson’s patients can take to immediately dry out their mouths. The strip dissolves in the mouth over a period of 30 minutes to an hour. “We found a way to deliver it so it would work fast and not be intrusive,” Farber says.
NH004 has been tested in an initial study designed to determine the optimal dose. A second study is planned for this summer. The Michael J. Fox Foundation awarded NeuroHealing a grant to fund part of the trial program.
The Fox Foundation grant was part of what Farber calls an “unusual and creative funding history.” He won’t reveal how much NeuroHealing has raised all together, except to say the company has been bootstrapped with government grants, disease-foundation grants, personal investments from the founders, and some angel funding. Farber says the company is looking for corporate partners to help take its best clinical candidates through the development process.
Finding such a partner will be vital for advancing the company’s third drug, NH0D2, which it is developing to treat premature ejaculation. NH0D2 is a variation of modafinil (Provigil), a drug to treat sleepiness. “We recognized a side effect,” Farber says, namely an improvement in sexual function. NeuroHealing completed preclinical trials, but needs a deep-pocketed investor to take the drug further. Farber hopes the market potential will capture the attention of the pharma community. “We think it’s a $4 billion market opportunity,” he says.
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