This week in psychedelic business news: FDA green lights a new psilocybin study; MindMed commences LSD treatment for ADHD; Sage Institute shuffles leadership.
This week in psychedelic business news, Tryp Therapeutics got approval from the Food and Drug Administration to proceed with the next stage of its psilocybin study on binge eating disorder. The pharmaceutical company will advance to Phase 2a of its clinical trial, which seeks to evaluate the effectiveness of therapy combined with TRP-8802—its proprietary psilocybin formulation—to treat the eating disorder. Tryp, which is also working on psilocybin treatments for fibromyalgia and hypothalamic obesity, among others, estimates the potential market value of its synthetic psilocybin to be worth $12.5 billion if proven safe and effective.
MindMed began a groundbreaking Phase 2a trial of its own. The psychedelic-therapy focused biotech company initiated a proof-of-concept trial of lysergic acid diethylamide (LSD) in adults with attention deficit hyperactivity disorder (ADHD). Patient enrollment is expected to start immediately in the randomized, double-blind, placebo-controlled trial which evaluates the safety and efficacy of low-dose LSD as treatment for ADHD, a disorder affecting 10 million American adults. According to co-primary investigator Dr. Matthias Liechti, this will be the first trial to “validly evaluate effects of very low doses of a psychedelic in patients.”
Mydecine—a biotechnology company focused on mental health and addiction treatment—signed a letter of intent with Maya—a holistic software solution for psychedelic practitioners—to co-develop a novel digital therapeutics (DTx) platform aimed at increasing the safety, efficacy, and accessibility of psychedelic-assisted treatments. Mydecine hopes the DTx platform will enhance treatment effectiveness when paired with its existing digital health platform, Mindleap, and medication-based treatments.
Ixtlan Bioscience, an Israeli biotech company focused on developing psilocybin-based treatment for Alzheimer's Disease and other forms of dementia, announced the filing of a new Provisional Patent with the United States Patent and Trademark Office (USPTO) for its Ixtlan AD Kit, a novel and proprietary psilocybin treatment for Alzheimer's and neuronal disorders. The kit—which combines a web-application with a physical, encapsulated receptor-activating product—hopes to enhance the therapeutic potential of psilocybin microdosing.
Finally, on the non-profit side of the of the psychedelic business, Sage Institute for Psychedelic Therapy announced on Wednesday that founding Executive Director Genesee Herzberg and co-founder and training director Jason Butler have left the organization to pursue other opportunities. The executive committee of the Sage Institute’s board of directors has assumed Dr. Herzberg’s responsibilities as the search for replacements begins.
For more psychedelic business news, watch our resident psychedelic investor James Halifax dive into these and other recent industry developments.