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Hello and welcome to the Pulse, the monthly psychedelics industry roundup from Technology Networks and Analytical Cannabis. Here, we’ll highlight some of the most significant psychedelic industry news from the past month, including important announcements, pre-clinical work and the latest from groundbreaking psychedelic clinical trials. Keep on the pulse of psychedelics and more by subscribing to our Breaking Science Newsletter below.
Kernel has published the results of a study funded by Cybin that it says demonstrates the effectiveness of its Flow1 system in tracking neural alterations induced by psychedelics. Traditionally, studying brain activity during psychedelic experiences has been hampered by reliance on self-reports and the temporal challenges posed by functional magnetic resonance imaging (fMRI) approaches. Kernel’s Flow1 device, utilizing near-infrared spectroscopy, allows real-time data collection, offering new insights into blood oxygenation changes related to neural activity.
Kernel’s placebo-controlled, single-blinded study monitored the effects of ketamine administration, revealing alterations in consciousness, increases in pulse rate and other physiological metrics and shifts in brain connectivity. The preliminary findings suggest that the recorded changes may predict clinical and cognitive outcomes, such as mystical experiences and depressive symptom reductions.
Compass Pathways has projected that psilocybin-assisted therapy could obtain regulatory approval and reach commercialization by the beginning of 2027. That exciting prediction is contingent on the success of their Phase 3 clinical trials of Compass’s proprietary psilocybin formula, COMP360, for treatment-resistant depression. The announcement was made at the Psych Global Symposium in London. Compass’s ambitious program, bolstered by a Phase 2b study showing significant improvement in depressive symptoms, also includes Phase 2 trials using COMP360 for PTSD and anorexia nervosa. It remains unclear whether the commercialization timeline refers to post-European or U.S. FDA regulatory approval.
- PharmaTher has completed a preclinical research study with the Terasaki Institute, successfully evaluating PharmaPatch™, a microneedle patch for delivering microdoses of DMT. The study suggests that the patch may overcome challenges related to oral and intravenous dosing, offering a less-painful method with a controlled release. The results suggest the Patch has potential for alleviating mood and anxiety disorders.
- PsyBio Therapeutics has become the first biotechnology company to receive formal government authorization to manufacture biosynthetic tryptamines, including its lead compound PsyBio-11142. PsyBio has spent two years chasing this approval, which will allow the production of sufficient quantities for human clinical trials.
- Psycheceutical Bioscience announced that the first patient has been dosed in a Phase I study evaluating its patented NeuroDirect™ ketamine topical delivery system for treating post-traumatic stress disorder (PTSD). Conducted in the psychedelic-friendly settings of Australia, the trial aims to test the safety, tolerability and pharmacokinetics of the drug in 24 healthy adult volunteers.
- Tryp Therapeutics, a clinical-stage biotech, has received the green light from the U.S. Food and Drug Administration (FDA) to proceed with its Phase 2a clinical trial at Massachusetts General Hospital for psilocybin-assisted psychotherapy in treating patients with irritable bowel syndrome (IBS). Tryp’s study will measure the intervention’s effect on chronic abdominal pain and other symptoms.