Drug repurposing company Algernon Pharmaceuticals has requested a pre-Investigational New Drug (IND) meeting with regulators in the hopes of launching a clinical trial in stroke patients for n,n-dimethyltryptamine (DMT), a naturally derived psychedelic compound. If approved, the trial could be the first psychedelic tested by a company in patients recovering from stroke.
The company’s compound, AP-188, is an intravenously delivered microdose of DMT that will not produced hallucinogenic effects, and it will seek a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
The DMT program fits with Algernon’s approach to repurposing existing compounds. Its lead asset is NP-120 (ifenprodil), a decades-old N-methyl-d-aspartate (NDMA) receptor glutamate receptor antagonist that has been approved in some markets outside the U.S. for circulatory disorders.
In recent years, the FDA has approved a marijuana-derived drug, Epidiolex(cannabidiol), for rare forms of epilepsy, and ketamine a dissociative anesthetic often used as a party drug–for treatment-resistant depression.
Academics and nonprofits have launched dozens of trials in recent years for psychedelics like 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, and lysergic acid diethylamide (LSD), primarily in patients with psychiatric diseases including depression, post-traumatic stress disorder, eating disorders, or alcohol use disorder.
DMT, a serotonergic agonist derived from the Psychotria viridis plant and used to make a traditional psychedelic compound called Ayahuasca, is in the same tryptamine family as psilocybin, but has not received the same amount of attention. COMPASS Pathways received an FDA Breakthrough Therapy designation for psilocybin in 2018 for treatment resistant depression.
Still, interest is increasing: it has been tested in clinical trials by academics in patients with depression. The first company-backed Phase I DMT trial, by London-based Small Pharma Ltd., launched in January in patients with anxiety and depression. And earlier this week, psychedelic specialty companies PharmaDrug and MindSet Pharma announced progress on preclinical programs researching DMT. PharmaDrug is exploring DMT for ischemia reperfusion injury in patients undergoing kidney transplantation.
And in November, Dublin-based GH Research, announced its DMT had completed the Phase I safety trial in patients with treatment-resistant depression for a similar psychoactive compound, 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT), and was beginning a Phase II trial.
Want to know more about psychedelics?
- How To Change Your Mind: The New Science of Psychedelics – Michael Pollan
- The Psychedelics Explores Guide
- A Really Good Day
- Psilocybin Mushrooms: A Practical Guide to the Types and Magic Effects of Psychedelic Mushrooms
- DMT: The Spirit Molecule: A Doctor’s Revolutionary Research into the Biology of Near-Death and Mystical Experiences
- Quantum Science of Psychedelics: The Pineal Gland, Multidimensional Reality, and Mayan Cosmology