Soin Neuroscience Files An Orphan Drug Application To Treat Systemic Sclerosis

Wednesday, June 7, 2017 Drug News
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DAYTON, Ohio, June 7, 2017 /PRNewswire/ -- Soin Neuroscience (, a biotech startup

based in Dayton, OH, has recently filed an Orphan Drug application with the FDA to treat systemic sclerosis/scleroderma with their developmental drug TV1001SR- which uses sodium nitrite as its active ingredient.

Systemic Sclerosis

is an autoimmune connective tissue disorder which is characterized by thickening of the skin and damage to small arteries. TV1001SR has been shown in multiple completed phase II and preclinical trials to enhance the growth of small arteries and promote blood flow to damaged tissue. This mechanism of action may prove to be quite helpful for patients suffering from systemic sclerosis.

Systemic sclerosis is an orphan disease states effecting less than 250,000 people in the US, and there are not many effective treatments that help the damage to small arteries. "Our modeling suggests that patients suffering from systemic sclerosis will see a marked improvement in blood flow and help reverse or prevent damage to the small arteries that are damaged by the disease," noted Dr. Amol Soin, MD, Founder and CEO of Soin Neuroscience.

Patients suffering from this disease often develop damage to their internal organs due to poor blood flow and develop painful ulcers in the distal portion of their fingers and toes due to the damage to small blood vessels. Dr. Soin noted that at times this pain can become debilitating.

"Another major advantage is that TV1001SR has been shown to be a good painkiller in patients who suffer from damage to small arteries. Given the non-addicting and non-sedating nature of the medication, it can truly help people who are suffering without the side effects of other painkillers."

Dr. Soin went on to say that "The mechanism of action of TV1001SR appears to treat the actual cause of the pain and 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. I really think we can help a lot of people."

Typically the FDA responds to Orphan Drug requests within 4 – 6 months of submission of the application. The Soin Neuroscience team is currently planning for a phase III trial to test TV1001SR for systemic sclerosis which it hopes to begin within the next year.

About Soin Neuroscience:

Soin Neuroscience (SNI) is a pharmaceutical startup company based in Dayton, OH that specializes in treating pain and other neurological conditions. Its lead compound, TV1001SR, is entering late stage trials to treat systemic sclerosis and diabetic peripheral neuropathy. SNI also has multiple other compounds in development including a way to restore functional motor and cognitive function after ischemic stroke, a method to treat intensive care unit myopathy, and is working on an option to treat Huntington's disease. The company was founded by Dr. Amol Soin who is also an inventor on most of the core technologies that are being developed. He can be reached at

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SOURCE Soin Neuroscience


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