Psychedelic Therapies Advance Through Clinical Trials as HMNC's Novel Ketamine Formulation Shows Promise
核心洞察
HMNC Brain Health (搜索)'s oral ketamine formulation KET01 demonstrated antidepressant effects without typical dissociation or cardiovascular side effects in a multicenter phase 2 trial across Germany, Poland, and the Czech Republic.
The slow-release oral formulation delays peak blood concentration for seven hours and produced rapid antidepressant signals within hours, with clear separation from placebo by day four.
HMNC is also developing nelivaptan, a vasopressin blocker, paired with genetic patient-selection tools that showed encouraging efficacy signals in a 338-patient phase 2 study.
The psychedelic therapy landscape is experiencing unprecedented momentum as clinical research accelerates and novel formulations demonstrate promising results. According to Hans Eriksson, M.D., Ph.D., chief medical officer for precision psychiatry company HMNC Brain Health (搜索), "We're in the second golden era of neuropsychopharmacology."
Novel Ketamine Formulation Shows Unique Profile
HMNC Brain Health (搜索)'s oral ketamine formulation, KET01, has completed a multicenter phase 2 study across Germany, Poland, and the Czech Republic, revealing a distinct therapeutic profile compared to existing ketamine treatments. Unlike intravenous ketamine or Spravato (esketamine), KET01 releases slowly through the gut, delaying peak concentration in the bloodstream for seven hours.
This dosing strategy produced antidepressant effects without the dissociation or cardiovascular side effects typically associated with ketamine therapy. The trial demonstrated an antidepressant signal emerging within hours of the initial dose, with clear separation from placebo appearing by day four—an unusually rapid response for an oral medication. Although the placebo group temporarily improved at the three-week mark, the early signal was strong enough to justify further development.
Targeting Stress Resilience Systems
HMNC is also advancing nelivaptan, a vasopressin blocker originally developed by Sanofi, which targets hormonal pathways of the hypothalamic-pituitary-adrenal (HPA) axis. This approach revisits therapeutic concepts that showed promise two decades ago but were stalled due to cumbersome diagnostic requirements.
In a 338-patient phase 2 study, pairing nelivaptan with the company's genetic selection tool yielded encouraging efficacy signals. This strategy represents a shift toward personalized therapies using predictive patient selection tools, which could dramatically expand accessibility compared to treatments requiring intensive oversight.
Research Momentum Reaches New Heights
Psychedelic research is advancing at an unprecedented pace. In the early 2000s, only a handful of researchers were conducting animal studies with mind-altering substances. Today, more than 100 papers on psychedelics are published every month, with a new clinical trial started every week.
Clinical trial participation has more than doubled, rising from an average of 1,100 patients per year between 2016 and 2018 to 2,450 patients per year between 2019 and 2021. The average trial size is 52 participants, increasing from 36 on average in phase I trials to 96 per phase III trial.
Current Clinical Landscape
Ketamine has generated the most research among psychedelics, with 140 clinical trials conducted for mental health and substance use disorders as of July 2021. This extensive research has supported the approval of Spravato for treatment-resistant depression and the widespread use of ketamine for major depressive disorder and suicidal ideation.
MDMA for PTSD is currently in phase IIIb trials and is expected to receive FDA approval by 2023, with MAPS (搜索) having invested under $100 million in development costs. Psilocybin for depression has completed data collection on a large phase IIb trial, with 26 phase IIb trials conducted or currently ongoing.
Industry Growth and Investment
Commercial interest has expanded rapidly, with more than 30 companies either running trials, having completed trials, or publicly indicating intent to conduct psychedelic research. Companies have sponsored an average of 10 trials annually over the last three years, with projections rising to 40 annually in 2024.
The largest sponsors include COMPASS Pathways, MindMed (搜索), Johnson & Johnson, and atai and its subsidiaries. Government sponsorship is also increasing, notably through US Veterans Affairs services, with signals from Germany and Australia suggesting further government funding is forthcoming.
Scaling Challenges and Solutions
While companies like Compass Pathways focus on psilocybin-based therapy paired with psychological support, HMNC's approach using predictive patient selection tools represents a strategy to address scalability challenges. Traditional psychedelic treatments often require intensive oversight, making widespread implementation difficult.
The field faces the challenge of translating compelling personal transformation narratives into successful phase III outcomes. Based on research from the Biotechnology Innovation Organisation, the probability of developing a novel compound into an approved medicine remains below 10%, though repurposing drugs for new indications has better odds at approximately 25%.