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Beckley’s 5-MeO-DMT Shows Rapid, Durable Antidepressant Effects in Phase 2b Study

This morning, Beckley Psytech shares topline data from its Phase 2b study of intranasal 5-MeO-DMT (BPL-003) in treatment-resistant depression (TRD). The study, the largest of the drug to date, printed positive results, with a significant and rapid antidepressant effect and favourable safety profile. Here, we take a closer look at the results and share our quick-take analysis with reference to GH Research’s similar Phase 2b study.

Beckley Execs Talk Phase 2b Data, Competition, and Phase 3 Plans

Psychedelic Alpha’s Josh Hardman sits down with Beckley Psytech CEO Cosmo Feilding-Mellen and Chief Scientific and Medical Officer Rob Conley to discuss today’s topline results from the company’s Phase 2b trial of intranasal 5-MeO-DMT (BPL-003) in treatment-resistant depression (TRD).

Pα+ Psychedelic Bulletin #202: Psychedelics Access ‘Within 12 Months’, RFK Jr. Says; Psychedelics in Washington; Lykos’ New CEO, CMO; New Zealand’s First Psilocybin Prescriber; Judge Recommends Schedule I Placement for DOI and DOC

RFK Jr. Envisages Psychedelics Access ‘Within 12 Months’ • Psychedelics in Washington: FDA, VA, and New Political Signals • Lykos Therapeutics’ New CEO and CMO, Amy Emerson Joins Board • New Zealand Approves First Psilocybin Prescriber • DEA Judge Recommends Schedule I Placement for DOI and DOC • and more…

Cautious Optimism, Lingering Questions: Researchers React to Compass’ Phase 3 Psilocybin Results

It’s been two days since Compass Pathways provided a first look at data from its Phase 3 program, by way of a limited readout from COMP005, a placebo-controlled study of its COMP360 psilocybin in treatment-resistant depression (TRD). Today, we share perspectives from various researchers who commented on the efficacy and safety signals, what they expect from COMP006, and how psilocybin might fare in the real world.

Compass Pathways’ Psilocybin Clears First Phase 3 Hurdle

This morning, Compass Pathways shared the first cut of Phase 3 data for a classical psychedelic, reporting a statistically significant MADRS difference vs. placebo and a reassuring safety profile in its trial of COMP360 psilocybin for treatment-resistant depression. Here, we provide our quick-take analysis and speak with company execs about the news.

The Library

Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.

The Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.

It’s exclusively available to our Pα+ subscribers, with new content added regularly.

Pα+ Library: Bifurcated Scheduling

Pα+ Library: we introduce some of the key concepts in the matter of bifurcated scheduling; a process by which an approved drug product may be placed in a different schedule to the substance itself. As we discuss in this piece, this could have significant repercussions for psychedelic research, legality, and even taxes.

Pα+ Library: Psychedelic REMS

Pα+ Library: we sketch out what a psychedelic REMS might look like, highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.

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