Tony McKinney, the founder and CEO of Ethismos Research Inc., has worked with the small molecule he plans to take into the clinic this year for the past 10 years. All the while he’s used the same support group of personnel to develop the molecule. Sometimes that group works and sometimes it’s on hiatus.

Now McKinney has put the band back together with Ethismos’ $50 million private placement, creating plans to fund a phase II study of its lead candidate, amitifadine, a small-molecule serotonin-preferring triple reuptake inhibitor for chronic pain, opioid-sparing and for tapering patients off of opioids while managing their pain and withdrawal. It will be tested first as an adjunct to opioids in patients with chronic noncancer pain.

Ethismos was born of Euthymics Bioscience Inc. as it acquired Euthymics’ intellectual property assets, 12 families of patents and patent applications, including those underlying amitifadine. McKinney was the founding CEO of both Euthymics and of Neurovance Inc., which was spun out from Euthymics as a sister company and later acquired in March 2017 by Tokyo-based Otsuka Pharmaceutical Co. Ltd. on the basis of a single asset in attention deficit hyperactivity disorder.

“Our goal is to reduce utilization of opioids by administering our medicine alongside the opioid, to reduce use over a six-month period to taper down so people don’t need as much,” McKinney told BioWorld.

Since the 2016 guidelines for opioid use were released, many people with chronic pain had their use tapered far too rapidly, McKinney said, and many have died, often of suicide, “because doctors and the health care system were afraid of opioids. Our approach embeds a validated tapering regimen alongside our medication.”

Amitifadine increases transmission of three neurotransmitters – serotonin, norepinephrine and dopamine – which is believed to relieve pain, improve mood symptoms, reduce the emotional impact of pain and moderate the psychiatric symptoms of withdrawal. The molecule has already been through initial FDA safety and dosing trials and it is ready for phase II efficacy trials, McKinney said.

McKinney plans to step into the clinic this year to study amitifadine’s safety and efficacy for treating chronic noncancer pain. The Cambridge, Mass.-based company also plans to assess amitifadine in a second phase II in either maintenance of depression remission after ketamine treatment, relapse prevention in methamphetamine dependence, or nicotine cessation for both combustible and e-cigarettes. The second study will most likely start in early 2021, McKinney said.

“Our priority is the opioid crisis,” he added.

Providing a non-opioid pain medication that also treats mood and psychiatric withdrawal symptoms is amitifadine’s strength, McKinney said. About 10 million Americans rely on chronic opioid use to treat their long-term pain and almost 50,000 die every year.

McKinney said that once amitifadine has been shown to work well in an opioid sparing and tapering program and that it’s safe and effective, other and larger companies will take notice.

“One or several big pharmas, domestic or international, or a big biotech, will be interested in one or more of these claims,” he said. “We will be ready for phase III at that point and we may get some interest.”

That’s when an opportunity to sell the company may occur, he said.

Payers will also be interested in some of those unmet medical needs because they’re all incredibly expensive, he added.

McKinney said he is confident that Ethismos, which means addiction in modern Greek and a word for building good habits in ancient Greek, will be successful because he’s been involved with the molecule for so long.

“I’ve been dealing with this drug for 10 years and I’ve been in biotech and pharma for 30,” McKinney said. “I’ve had a lot of trials fail. That’s the way biotech is. And I’ve raised a fair about of money, not quite $400 million over the years.”

The new round of funding is being led by led by managing broker-dealer Brokerage Services.

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