Montana veterans who suffer from post traumatic stress disorder as a result of military service from 2001 on may be eligible to participate in a new clinical trial to test an experimental medicine.
"We believe it improves sleep quality, and that's very different from sleep quantity," said Seth Lederman, president and chief executive officer of Tonix Pharmaceuticals. "It is not a sleeping pill. It is not a narcotic. And it is not addictive."
Monday at a news conference, Lederman and representatives from Providence St. Patrick Hospital and the University of Montana announced the launch of The Honor Study that aims to test the drug called Tonmya. Researchers are seeking veterans with PTSD who are willing to participate in the study (see related box for details).
"We think that this (medicine) can lead to healing," said Lederman, also former associate professor at Columbia University's medical school.
The nationwide study is targeting 550 participants, and U.S. Sen. Jon Tester helped bring the project to Missoula. In a video message, the Democrat said an estimated 15,000 veterans in the state experience PTSD, making it hard for them to hold jobs and provide for their families.
"We'll be trying to treat one of the largest unseen wounds in the world," said Tester, who also thanked veterans in attendance for their service and sacrifice.
At the news conference at St. Pat's, researchers talked about results of earlier trials, the hope for the current phase, and the reason Missoula is one of an estimated 40 study sites in the U.S.
"The best patient care seems to occur in institutions where research is occurring," Lederman said. "Research is a magnet for the best young minds and the most dedicated faculty, and Montana is a fertile ground for a growing clinical enterprise in PTSD."
The study is free to veterans who participate. Tonix is sponsoring the research, which Lederman said cost an estimated $120 million in its first two phases and could cost some $60 million in its third phase.
Participants place the medicine or a placebo under their tongues at bedtime every night for 12 weeks, he said. The active ingredient in the drug was initially developed as a treatment for muscle spasms.
In general, he said the medicine performed well compared to others for psychiatric conditions when it comes to the balance of risk versus reward. He said side effects include insomnia, dry mouth and sleepiness, but not weight gain or increases in blood pressure or blood sugar levels.
"This research has taken decades to bring to fruition," Lederman said.
An earlier trial with some 231 participants included tests of a low dose and high dose of the drug, and the results of the high dose were encouraging, he said. In Phase 2, some 21 percent of patients were in remission in weeks eight and 12 of the study compared to 5 percent of the patients who took a placebo.
"We're hoping this study will confirm the results of that earlier study," Lederman said.
Veterans who complete the blind phase of the research will be invited to take the active medicine for three months in a study extension, he said. A news release described Tonmya as "Cyclobenzaprine HCI Sublingual Tablets."
Lederman anticipates results will be out in less than a year, before the end of 2018.
Matt Kuntz, with the National Alliance on Mental Illness in Montana, said he's been working to help Montanans who struggle with PTSD since he lost a family member in 2007. This summer, he read a Facebook message from the wife of a veteran that hit him hard.
"When are the treatments going to get better? I don't know how much longer we have to wait," the message said.
Montana counts the highest per capita suicide rate in the country, Kuntz said. He said he didn't have a good answer for her, but he's spent probably the past six years trying to bring top-level mental health treatment to the state.
"Whether it's this medication or something else, the best treatment happens where research happens," he said.
At this point, he said the infrastructure needs to be pieced together, and he's grateful that researchers agreed to take a risk on Montana: "I want to thank them for developing treatment for vets, for realizing this is important, and for trying to solve one of our generation's biggest challenges."
He also thanked UM and St. Pat's, "who stuck their necks out," along with Tester. Kuntz's stepbrother was a Montana National Guardsman with PTSD who died by suicide, according to the NAMI website. At the news conference, Kuntz said Tester was the politician who called him on his cellphone after he started a statewide, then nationwide, effort to help in response to his stepbrother's death.
"That was in summer 2007, and he (Tester) has never stopped trying to work to improve the system for Montana's veterans," Kuntz said.
Reed Humphrey, dean of the UM College of Health Professions and Biomedical Sciences, said researchers hope to accelerate the development of effective treatments with the Missoula trial. The effort amplifies the importance of community collaborations, he said, and UM is honored to participate in the trial through its Neural Injury Center.
"We are very excited to participate in this clinical research study to address public health challenges and unmet medical need," Humphrey said in a statement.
In a statement, Joyce Dombrouski, chief executive of Providence Montana, also thanked those involved for participating: "Providence St. Patrick Hospital has a long history of supporting research and innovation. The Phase 3 HONOR Study may lead to advancement of an effective treatment option for veterans suffering from PTSD."
Because preliminary evidence shows clinical benefits of Tonmya and the market needs better drugs for PTSD, the U.S. Food and Drug Administration granted the new drug "breakthrough therapy designation," Lederman said. He said the support from Tester helps expedite the clinical development of the medicine.