The United States of America is on the verge of a revolution of psychedelic treatment options, and a surge of foreign capital and biotech is hoping to give natural treatment options a push toward the finish line.
Psychedelics in America have gained ground in Congress, on the local level and in research circles, leaving one final major hurdle to bring the treatment options to market: Approval by the Food and Drug Administration. With that crucial step remaining, overseas investment has emerged as a potential catalyst for getting research trials over the finish line.
And that increased investment in time and resources has rephrased the conversation from ‘if’ FDA approval will come to asking ‘who?’ will be the first and ‘when’ will that final domino fall.
The impact of foreign capital on psychedelics took a major step forward this week when Awakn Life Sciences Corp announced its intention to expand its commercial operations into the United States. Awakn plans to enter into a licensing partnership with Revitalist Lifestyle & Wellness Ltd., a US-based chain of ketamine wellness-clinics.
What makes this partnership especially intriguing is the status of Awakn’s clinical trials on ketamine-assistant therapy to treat addiction. The treatment, which has a “near-term focus on Alcohol Use Disorder,” has reached Phase III of clinical trials, and it was recently announced that grant funding from the United Kingdom’s National Health Service would contribute 2.5 million Canadian dollars of the 3.75 million the project is projected to cost.
At the time, the release announcing the Phase III trials said that Awakn was seeking “marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in the UK and the US.” Now, with Awakn making moves into the American consumer market, ketamine-assisted therapy options are poised to make a real push toward FDA approval.
According to Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy, the pieces in place for these clinical trials make it feasible to foresee ketamine therapy being readily available in the near future.
“The financial commitment by the UK Government emphasizes the promise of this treatment and the scientific rigor behind the trial,” Morgan said. “This, coupled with running the trial in the NHS settings and working closely with regulators throughout, means that the probability of quick adoption is very high, should the results of this trial fulfill their early promise.”
After receiving “ground-breaking positive data” from its Phase II A/B trial, the Phase III trial is set to seek specific data to provide “definitive evidence of the efficacy of ketamine-assisted therapy for treatment of AUD.” However, based on the results of the Phase II, hopes are high for the data to help Awakn move toward approval for licensing this treatment method.
The Phase II trial was the first ever controlled trial for ketamine-assisted therapy, and saw 96 patients with severe AUD evaluated for a 6-month period. Patients who participated saw a significant increase in “total abstinence” of alcohol use, seeing an 86 percent rate of abstinence post trial after just 2 percent abstinence prior to the trial. In addition, the group of patients who took ketamine alongside therapy were 2.7 times less likely to relapse after six months than the placebo group.
It’s just one trial, seeking to treat one specific condition with a specific compound, however, Morgan said the early results give hope for treating the complex mental health issues that exist in modern society.
“Alcohol Use Disorder is a pervasive and persistent public health issue, affecting at least 390 million people globally. Treatment rates are low and relapse rates post treatment tend to be high. We urgently need new and more effective treatments,” Morgan said.
“We found that controlled, low doses of ketamine combined with manualized psychological therapy can significantly increase post treatment abstinence rates. This is extremely encouraging, as we normally see three out of four people returning to heavy drinking within twelve months of treatment. The data we’ve collected from this study paves the way for a paradigm shift in how AUD is treated”
Awakn is not the only foreign entity pushing the envelope on ketamine treatment, either. Earlier this year, German psychedelics startup Atai Life Sciences was granted FDA approval to conduct a clinical trial on how a non-psychedelic form of ketamine can be used as an option for therapy-resistant depression.
Atai is backed by Peter Thiel, a German-American billionaire, and was the third psychedelic biotech firm to go public in the U.S. More importantly, the involvement of Thiel and the addition of psychedelic companies to Wall Street has the industry racing to make the first major breakthrough in terms of FDA approval.
COMPASS Pathways was the second publicly traded company listed on the Nasdaq, and has a number of psychedelic trials in the works. Earlier this year COMPASS presented the American Psychiatric Association annual meeting with “positive data from the largest randomized, controlled, double blind study of psilocybin therapy ever completed.” In July, COMPASS announced a Phase II trial to study the efficacy of psilocybin in treating anorexia nervosa.
With the influx of new treatment methods, the chief medical officer at COMPASS said early promising results should make it clear: More trials and research only stands to help patients who need it the most.
“Our mission is all about developing mental health innovations through scientific evidence…” said Dr. Guy Goodwin. “We now need to continue our research to understand if this can be replicated in even larger trials.”