When Barry Fogel first started developing a new treatment 15 years ago, his main goal was to help his own patients. Fogel, a physician trained in both psychiatry and neurology, saw many patients with a movement disorder called tardive dyskinesia (TD). The condition—which can be caused by drugs that block dopamine, such as antipsychotics—is characterized by involuntary movements of the face like puckering, closed eyes, and grimacing. Some patients suffer writhing of their hands and feet, or difficulty moving their upper bodies. “At its worst, it’s quite disfiguring,” Fogel says. And there is no approved drug to treat TD.
Fogel developed a treatment for the condition in the late 1990s, patented it, and set out to try to get it on the market. On Monday, Fogel’s dream took a huge leap towards reality when his Waltham, MA-based company, Synchroneuron, announced it had raised its first round of venture capital—$6 million from Morningside Technology Ventures. It’s enough to take the drug through a substantial portion of the clinical trials Synchroneuron will need to complete to apply for FDA approval, says chief financial officer Marc Cote.
Synchroneuron’s journey from idea to Series A could be a case study in stick-to-it-tiveness—and the value of networking. Fogel, a clinical professor of psychiatry at Harvard Medical School, suspected that modulating two brain chemicals, glutamate and GABA, would relieve TD. So he did a bit of experimenting on his own patients, prescribing them existing drugs that targeted those chemicals but were approved to treat other conditions. “I established that if you modulate glutamate, in particular, the TD gets better,” Fogel says.
So Fogel developed and patented a method for using a drug called acamprosate to do just that, and in 2004, he licensed it to San Diego-based Somaxon Pharmaceuticals (NASDAQ: SOMX). But Somaxon was developing an insomnia drug, which took precedence over the acamprosate program, Fogel says. “They didn’t give sufficient resources to acamprosate,” he says. “The progress was disappointing.” Somaxon declined to comment. (A sidenote: Somaxon eventually did get its insomnia drug on the market, but has struggled to make it stand out in a competitive market.)
In 2007, Fogel got his patents back from Somaxon and began looking for an alternate path to FDA approval. It wasn’t easy: Fogel and his wife had to do all the work tomaintain the patents themselves, in their spare time. Fogel’s experience with Somaxon made him reluctant to seek out another partner. “My concern was that if I licensed it out, I would lose control,” he says. Fogel approached several VCs, but was continually turned down for funding. “They said, ‘fascinating market, great patent position, but where’s your team?'” Fogel recalls. “They said, ‘You’re a Harvard professor—what do you know about developing drugs?'”
Then a relative of one of Fogel’s patients introduced him to William Kerns, partner and CEO of Waltham, MA-based Accellient Partners, a drug-development consulting firm. The two co-founded Synchroneuron and operated it as a virtual company, drawing from the expertise of Accellient’s staff of physicians and PhDs. Accellient also introduced Synchroneuron to potential funding sources, eventually locking up the deal with Morningside, a Hong Kong-based investment group.
Kerns, who is Synchroneuron’s acting CEO, says the company has not yet determined whether acamprosate will be its lead development candidate or if it will go forward with an entirely new molecule. The company has been conducting animal trials to identify new formulation opportunities, he says. Synchroneuron expects to identify a lead drug candidate and begin Phase 1 studies by mid-2012. If all goes well, Phase 2 studies should start in the first quarter of 2013.
Fogel adds that while Synchroneuron’s main focus will be the TD compound, the company has identified future opportunities in other movement disorders, such as Parkinson’s disease and Tourette Syndrome. Still, he says, the opportunity in TD alone “is substantial.” Although no national surveys have been done to measure the size of the market, he says, the number of patients with the condition “could be as high as a million.”
For Fogel, the Series A marks a happy ending to the long and often frustrating story of his quest to help patients with TD. “This has been a considerable strain for my wife and me, but we believed eventually the value would come out,” he says. “It’s satisfying to see it come to fruition.”
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