Tuesday, February 7, 2012

Synchroneuron focuses new funds on movement disorder drug

By Lori Valigra

Synchroneuron Inc., a biotech company that emerged from stealth mode Monday with a $6 million Series A financing, said it will use the funds to finish developing a new formulation for a chemical compound that is approved for other indications, company executives told Mass High Tech in an interview.

The company aims to have its repurposed chemical compound, targeted at a movement disorder called tardive dyskinesia (TD), in Phase 1 trials by the end of this year and Phase 2 trials at the beginning of 2013, said Dr. William Kerns, interim CEO of the Waltham-based company.

TD is a usually irreversible and often disfiguring movement disorder caused by taking dopamine antagonists, antipsychotic medications and selected drugs used to treat nausea and vomiting. There are currently no FDA-approved therapies for TD, Kerns said. Synchroneuron is developing an oral drug that simultaneously affects excitatory and inhibitory pathways to balance them, and thus counter the twitches and jerking movements that accompany TD, which occurs in up to half of patients who take first-generation antidepressant drugs. Millions of people worldwide suffer from such movement disorders, which can keep them essentially housebound, according to the company. The treatment will be lifelong or until the symptoms subside.

Synchroneuron’s drug is a reformulation of a chemical compound that already is sold by other pharmaceutical companies for other indications, Kerns said. He would not reveal the compound’s name, but said his company’s drug candidate for TD is novel enough that Synchroneuron has applied for patents for it. The company also plans to develop other movement disorder-related drugs going forward.

The company was founded by inventor and neurologist Dr. Barry Fogel and the principals of Accellient Partners LLC, a consultancy in Waltham. Kerns also is CEO of Accellient, whose staff of 20 physicians and PhDs serve as the virtual employees of Synchroneuron, which itself has three employees: Kerns, Fogel and chief financial officer Marc Cote.

Fogel explained that he developed the drug candidate in the late 1990s to treat his patients with particularly difficult TD. He applied for patents, formed Synchroneuron LLC with family and friends, and in 2004 licensed the patents to an existing pharmaceutical company, Somaxon Pharmaceuticals Inc. of San Diego, Calif. “It was a secondary project for them, so in 2007 I got the patents back,” he said.

Through family members of a patient using his drug, Fogel was introduced to Kerns, and the two hammered out a business plan for Synchroneuron Inc.

Kerns said that this year the company will focus on developing the formulation and Phase 1 trial for the TD drug, using part of the recent funding, which will be available in three tranches. He would not comment on the amount for the first tranche. Since it is a reformulated drug, Synchroneuron will follow FDA 505(b)(2) procedures, an abbreviated new drug application that does not require repeating nonclinical toxicology studies already done on the compound, but does require clinical trials through Phase 3. Other possible formulations of the drug in the future may target Parkinson’s and Tourette Syndrome, Fogel said.

While the company initially is focusing on the repurposed drug, in the future it might develop its own compounds. “We are looking at other opportunities to bring into the portfolio, and we are not excluding new chemistry,” Kerns said.