Search for a cure: Missoula to host clinical trials in PTSD drug research

Matt Kuntz, executive director of the Montana chapter of the National Alliance on Mental Illness, left, welcomed Monday’s announcement by Tonix Pharmaceuticals that it will hold phase III clinical testing for a new treatment for PTSD in Missoula. Dr. Jason Molinaro, a psychiatrist trained at the Department of Veterans Affairs who now works at Providence St. Patrick Hospital, will serve as one of the study’s principal investigators. (Martin Kidston/Missoula Current)

A decade removed from the loss of his brother to suicide, Matt Kuntz leads a crusade that has taken him across the country, from town-hall meetings in Montana to the company of former President Barack Obama.

Along the way, he’s forged small victories, helping other war veterans and family members deal with the mental health issues that surround post traumatic stress disorder. The signature wound of the nation’s recent conflicts in the Middle East, he knows the challenges personally.

“I lost a family member to PTSD in March 2007, just 15 months after he came home from Iraq, and I’ve been at this ever since,” said Kuntz, who chairs the Montana chapter of the National Alliance on Mental Illness. “It’s been a hard journey. Hard to try and help people. Hard to try and help navigate people through losing family members.”

On Monday, Kuntz – a former Army officer and West Point graduate – embraced a new partnership between the University of Montana, Providence St. Patrick Hospital and Tonix Pharmaceuticals that will open a clinical research site in Missoula to explore a cure for PTSD.

As part of the initiative, Tonix and its partners will hold Phase III HONOR trials to evaluate a new drug in clinical testing. Known as Tonmya, the pharmaceutical has already received a breakthrough therapy designation from the U.S. Food and Drug Administration.

“The designation as a breakthrough therapy acknowledges that PTSD is a significant mental health disorder and that Tonmya has the potential to provide benefits not available in existing medicines,” said Dr. Seth Lederman, president and CEO of Tonix. “It was only the 10th psychiatric product to ever get this designation, and it’s the most expedited form of review that FDA offers.”

Sponsored by Tonix, the study will be conducted by St. Patrick Hospital and UM as the primary investigators. The trial looks to recruit more than 500 participants, all veterans who experienced a traumatic event during military service after 2001, the year the U.S. invaded Afghanistan, launching the longest-running military engagement in the nation’s history.

“The Missoula site is part of a nationwide study targeting the total enrollment of up to 550 participant veterans who are experiencing ongoing, disabling PTSD stress symptoms such as nightmares, flashbacks and agitation,” said Reed Humphrey, dean of the College of Health Professionals and Biomedical Sciences at UM. “Through the Missoula trial and nationwide study, we hope to accelerate the development of new, effective and safe treatments for PTSD.”

Veterans who suffer PTSD generally display symptoms including nightmares, flashbacks, agitation and irritability. And while it’s painful for those suffering from PTSD to talk about their traumatic experiences and symptoms, Lederman said veterans have proved up to the task in earlier phases of the study.

“Subjects that participate in our trials are not participating to help themselves,” Lederman said. “It’s truly out of a sense of altruism. What we hear across the country when we get feedback from them and the principal investigators is that they’re doing it to help their brothers and sisters in arms.”

Dr. Seth Lederman, president and CEO of Tonix, said Missoula was well suited to serve as a research site for clinical testing. (Martin Kidston/Missoula Current)

While Tonmya remains experimental, it has shown success in early phases of study, Lederman said. The active ingredient, cyclobenzaprine, was initially used to treat muscle spasms and has decades of use with humans.

But the new formulation, taken under the tongue, has shown promise in treating sleep quality. That’s not the same as sleep quantity, Lederman said, as Tonmya isn’t a narcotic and hasn’t shown any addictive qualities.

Taken at bedtime, the active ingredient arrives at the brain when the brain is processing memories. Because PTSD is a memory processing disorder, Lederman said, helping it to process thoughts may serve as a treatment.

“This research has taken decades to bring to fruition,” Lederman said. “It’s essential for us to recruit patients, otherwise there’s no way for us to know definitively or scientifically what advantages it has.”

Joining hospital and university officials in Monday’s announcement, Lederman described Missoula as the right place for the phase III HONOR study to evaluate the drug’s effectiveness.

Montana claims more veterans per capita that nearly all other states, as well as the highest rate of veteran suicides in the nation. According to a VA report released this year, the suicide rate among Montana veterans is nearly double the national average.

With PTSD and suicide are at the forefront of medical discussions, UM and St. Patrick Hospital have taken steps toward treatment through recruiting and internal development. The university hired Cindy Laukes to head its Neural Injury Center, and St. Pat’s acquired Dr. Jason Molinaro, a psychiatrist trained at the Department of Veterans Affairs.

Both Laukes and Molinaro will serve as principal investigators in the phase III study.

“Montana is a fertile ground for a growing enterprise in clinical research for PTSD,” Lederman said. “I believe the HONOR study and the participation of St. Patrick Hospital and the University of Montana could be a spark that will hopefully set off an explosion of research on PTSD in Montana.”

That came as pleasing news to Kuntz, who has watched with frustration as mental health treatment among the veteran population struggles for direction and positive outcomes.

That was evidenced by a recent Facebook message he received – one that’s kept him up at night. It came from the wife of a veteran who is struggling with PTSD. Simply, the wife asked when the treatment would get better, saying she didn’t know how much longer they could wait.

“I didn’t have a great answer for her,” said Kuntz. “Whether it’s this medication or something else, the best treatment happens where research happens. Regardless of whether this works, Tonix has brought that training into Montana. We need that infrastructure to improve the care of Montanans.”