Developing treatments for chronic diseases
 

Dayton-area entrepreneur on cusp of ‘billion-dollar’ product (Exclusive)

by Tristan Navera
Dayton Business Journal – Febuary 4, 2015

Dr. Amol Soin is setting his sights on a new drug with immense potential for pain relief. It also has huge potential for helping to create the next billion-dollar company in the Dayton region.

Soin, who is head of Centerville-based Ohio Pain Clinic, is part of a team of physicians developing a drug that treats diabetic neuropathy pain. Soin and his team filed a patent last February and filed an Investigational New Drug Application with the U.S. Food and Drug Administration in December, paving the way for clinical tests to be done locally starting within a few months.

If the results continue to be encouraging, the drug could be introduced on a national scale. And it could have a major effect. About 300 million people worldwide suffer from diabetes, a number expected to grow to 450 million by 2035.

“It’s got the potential to be a $1 billion-a-year drug,” Soin said, noting major national drugs intended to treat pain, like Lipitor and Lyrica, exceed $1.5 billion a year in sales.

The drug Soin co-invented features enteric coated, time-released sodium nitrite, which is intended to stimulate blood vessel growth and has been shown in early tests to reduce pain in patients with diabetic neuropathy, but it is not a narcotic or a sedative.

“A non-narcotic, non-sedative, non-addicting drug to treat pain – really could be the holy grail,” Soin said. “I think this will be a real game-changer. For far too long we have been treating pain with addicting narcotics and finally we will have an option that treats the ’cause’ of the pain instead of masking symptoms. It will also be beneficial to society as a whole to have fewer narcotics on the streets.”

Poor blood circulation, especially to the feet, is one of the long-term results of that disease which can cause significant pain. But drugs for pain relief are commonly sedatives or narcotics — and addicting. That can result in some addicts then turning to illicit drugs like heroin, which can be cheaper. Physicians who prescribe controlled substances also must get stringent additional medical licenses, and the new drug would be a way around that.

This new drug doesn’t just treat the symptoms, it treats the cause of the problem itself, Soin said. By stimulating blood vessel growth, the drug could help increase blood flow to the feet, which would speed up wound healing and cut down on amputations.

The drug is set for a Phase 2 study which involves 30 patients who will visit Soin’s clinic three times over 12 weeks. The study will be done in Dayton, with some of the patients receiving placebos. All will be compensated.

Soin has gathered additional medical expertise to his clinical advisory team to develop the drug, including Dr. Edgar Ross, Medical Director for Pain Management at Harvard University, and Dr. Nagy Mekhail, Director for Pain Management Research and Education at the Cleveland Clinic.

The next phase would be a major national study — where a national clinical trial is undertaken on a larger scale. Soin said that could entail partnering with “big pharma.” The cost of such a study would be extensive, $15 million to $50 million depending on the number of people and clinics required to participate. But if the data is encouraging, he said the physicians would look to raise venture capital or consider an IPO to fund the next phase.

“There’s huge potential here, if the data from this study looks good,” Soin said.

Soin, who owns the Ohio Pain Clinic, is an inventor of medical devices and a member of the Dayton Business Journal Forty Under 40 Hall of Fame. A native of Beavercreek, he is also a clinical professor of surgery at Wright State University, and the medical director for pain management at Greene Memorial Hospital and the Indu & Raj Soin Medical Center, named after his parents.

In 2011, he introduced the Electrical Nerve Block, a new effort to relieve pain that he invented.

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