Soin Neuroscience, a biotech startup based in Dayton, OH, has recently signed a drug development deal with Cleveland Diabetes Care for SNI’s lead developmental pain drug TV1001SR- which uses sodium nitrite as its active ingredient to treat neuropathic pain.
Terms of the deal include cash milestone payments and a royalty in exchange for exclusive worldwide rights to SNI’s lead drug- TV1001SR. Dr. Amol Soin, founder and CEO of Soin Neuroscience, is an inventor of the drug and a practicing pain management physician who has witnessed the opioid epidemic cripple his hometown of Dayton, OH.
Dr. Soin also is the current president of the State Medical Board of Ohio- appointed to the board in 2013 by Governor John Kasich. “As physicians, we have limited tools to treat pain since most of the stronger painkillers are addicting. It is important for us have options to treat pain without opioids- we desperately need newer safer medications. This is what led me on this journey of research and development- to help those who are suffering without creating addicts,” Dr. Soin said.
Cleveland Diabetes Care (CDC), led by its CEO Dr. Charles Richardson, MD, plans to move the drug through its final clinical stage, obtain FDA approval, and commence market launch. Dr. Richardson, who is also the founder of CDC, is a successful biotech entrepreneur and inventor who has founded several successful biotech companies including Cleveland Heart and Transworld Med as well as several other businesses.
“I am excited that TV1001SR will be in capable hands to move forward with a team led by Dr. Richardson who has the talent and skill set to help take this product to market,” Dr. Amol Soin noted.
In a recently completed Phase II trial of TV1001SR, patients who suffered from painful diabetic neuropathy noted significant reduction in pain. This is compelling since the drug offers a new way to treat pain with a new type of medication that lacks addiction or sedating side effects. Given the rise of abuse and overdose deaths related to opioids, new painkillers that are non-opioid in nature are desired.
The recently completed Phase II trial also demonstrated an improvement in nerve conduction velocity which may indicate an improvement in nerve function and nerve health. Dr. Amol Soin and the team of scientists recently filed an additional method of use patent based on this new finding. “If our modeling is correct, not only would the medication treat pain, but also potentially help improve nerve function and nerve health. This new finding is very exciting and shows that drug can have additional benefits and applications outside of just pain,” Dr. Soin noted.
Soin Neuroscience recently filed an orphan drug application for TV1001SR to treat systemic sclerosis and expects to hear back from the FDA within the next 2 – 3 months. The next steps for the drug development include completing the final/pivotal Phase III trials for diabetic neuropathic pain and systemic sclerosis. After those trials are completed, Dr. Soin hopes the drug will be ready for a NDA (new drug application) with the FDA which would allow the medication to be available to the public.
“I am truly excited to see this drug move forward. I can’t help but think about how many patients can benefit from this. Finally, we may have a new medication to treat pain- and one that lack addiction or sedation,” Dr. Soin noted.
“Another major advantage is that TV1001SR has been shown to be a good painkiller in patients who suffer from damage to small arteries- like peripheral artery disease.”
Dr. Soin went on to say that “The mechanism of action of TV1001SR appears to treat the actual cause of the pain and instead of masking the symptoms. It should also improve the symptoms a patient experiences while at the same time helping to improve the blood flow that was lost due to damage to the small blood vessels and improve the nerve conduction velocity. I really think we can help a lot of people.”