Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed
In big industry news, MAPS has published the second part of its long-awaited Phase 3 trial of MDMA-assisted therapy for PTSD. Results of the second Phase 3 trial have now been published in Nature Medicine, showing details of MDMA-assisted therapy for posttraumatic stress disorder.
- “…45 of 52 (86.5%) participants treated with MDMA-AT achieved a clinically meaningful benefit, and 37 of 52 (71.2%) participants no longer met criteria for PTSD”
- The MDMA group achieved remission of PTSD at more than double the rate of the placebo group (reduction in CAPS-5 score was 23.7 in MDMA group vs 14.8 for placebo group, both with therapy).
MindMed has completed dosing of its main Phase 2b clinical trial. The study — investigating LSD for Generalized Anxiety Disorder (GAD) — has dosed 198 participants across 20 clinical sites.
“With growing public interest in the benefits of psychedelics, it is now crucially important that we work on scaling up safe and legal access to these therapeutic compounds. Beckley Waves already has an impressive track record of founding and investing in startups that are building the care-delivery infrastructure, and this new funding gives us the resources to continue this important work,” said Amanda Feilding, Founder and Director of Beckley Waves.
The new funding will enable Beckley Waves to continue building and investing in the next cohort of startups that will provide the infrastructure and services for expanding safe and legal access to psychedelic therapies worldwide.
Reunion Neuroscience Inc. Announces FDA Clearance of IND Application to Initiate a Phase 2 Study of RE104 for the Treatment of Postpartum Depression
Reunion has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2 study of RE104, a novel serotonergic psychedelic compound, for the treatment of postpartum depression (PPD). The Phase 2 study, the RECONNECT Trial, is a multicenter, randomized, double-blind, parallel-group, active-dose placebo-controlled study, which will evaluate the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with PPD. The study is expected to begin in Q4 2023 with a targeted data readout in late 2024.
A new study published in Nature shows that MDMA can reduce difficult experiences with other psychedelics.
“Co-use of MDMA with psilocybin/LSD may buffer against challenging experiences and enhance positive experiences” was published by researchers from Imperial College London and New York University’s Langone Center for Psychedelic Medicine.
The survey followed almost 700 people who’d used LSD or psilocybin, with 27 using MDMA in conjunction with the classic psychedelics. The results suggest that small doses of MDMA can potentially minimize the effects of a bad trip.