First week of the site. Here's what mattered.
The EPIsoDE Trial: Mixed Results, Important Nuance
The biggest scientific development of the week was the publication of the EPIsoDE trial in JAMA Psychiatry. The German Phase 2b randomized controlled trial tested 25mg psilocybin in 144 patients with treatment-resistant depression.
The headline is complicated. Psilocybin produced a clinically meaningful reduction in depressive symptoms. It did not, however, meet the primary endpoint — a statistically significant treatment response at week 6. Response rates were 17% in the 25mg group versus 12.5% in the 5mg group and around 10% in the active placebo group.
This is not a failed trial. It's an inconclusive one, which is a different thing. The authors note the study was likely underpowered for the primary endpoint. What it does is add to a pattern: psilocybin consistently produces symptom improvements in TRD patients, but the effect sizes in controlled trials are smaller and less consistent than the earlier open-label work suggested.
Otsuka Buys Transcend for $1.2 Billion
Otsuka's U.S. subsidiary agreed to acquire Transcend Therapeutics for up to $1.225 billion. Transcend's lead compound TSND-201 is a methylone analog — chemically related to MDMA — being studied for PTSD. Phase 3 is recruiting.
The deal is notable because Otsuka is a major pharmaceutical company betting that the regulatory pathway for entactogen-assisted therapy is still open despite the FDA's rejection of Lykos's MDMA application last year.
Lykos: Three Papers Retracted
The journal Psychopharmacology retracted three Lykos-related MDMA papers, citing undisclosed competing interests and unethical conduct at a Canadian trial site. Lykos disputes the decision.
Oregon's Program Is Struggling
Oregon's psilocybin service centers are closing and facilitators aren't renewing licenses. The program is required by law to fund itself through licensing fees — and as revenue shrinks, fees have to rise. Lucid News has the full picture.
New Trials Worth Watching
Two new trials registered this week: the University of New Mexico's Phase 1 study of group-format psilocybin-assisted therapy for PTSD (NCT07506395), and Indiana University's Phase 1/2 trial targeting veterans and first responders with both treatment-resistant depression and active substance use disorder.
That's the week. Back Monday.