Phase 2 Trial On Ayahuasca's Active Ingredient Puts Small Pharma On Track To Winning The Psychedelics Race

Small Pharma Inc. DMTTF DMT, a biotech company focused on psychedelic therapies, has begun its phase 2a clinical trial on SPL026.

SPL026 is a proprietary version of DMT, also known as the active ingredient in ayahuasca, a hallucinogenic beverage used ceremonially by native people in the Amazon basin.

The research is studying the application of DMT in association with psychotherapy for the treatment of major depressive disorder.

The news makes Small Pharma one of the few companies in the space to lead phase 2 trials with a psychedelic molecule. Others include Compass Pathways CMPS and MindMed MNMD.

“The world’s first regulated clinical trial for DMT-assisted therapy targeting MDD is underway and we continue to make rapid progress. This is a key study for our DMT-assisted therapy portfolio as we assess the effectiveness of our lead candidate to treat MDD,” said Dr. Carol Routledge, chief medical and scientific officer of Small Pharma.

The company completed the phase 1 part of this research last month, which showed that the formulation had “a favorable safety profile with no serious adverse events.”

Now, the 42 patients taking part in the phase 2 proof-of-concept study have been given their first dose at two clinical trial sites in the UK: Hammersmith Medicines Research and MAC Clinical Research.

Topline results from the study are expected by the first half of next year.

Photo by Pretty Drugthings on Unsplash.