The Week of

November 14, 0225

Genentech's multiple sclerosis treatment shows major promise; atai Beckley to meet with the FDA about its new depression treatment.

In Psychedelics and Neuroscience...

Genentech, a member of the Roche Group, announced that the first Phase III of two pivotal, similarly-designed Phase III studies (FENhance 1 and 2) in patients with relapsing multiple sclerosis (RMS) met its primary endpoint.

Fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, significantly reduced the annualized relapse rate (ARR) compared to teriflunomide over a period of at least 96 weeks of treatment.

Fenebrutinib targets cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. Check it out: https://www.businesswire.com/news/home/20251109262712/en/Genentechs-Fenebrutinib-Shows-Unprecedented-Positive-Phase-III-Results-as-the-Potential-First-and-Only-BTK-Inhibitor-in-Both-Relapsing-and-Primary-Progressive-Multiple-Sclerosis

New research from the University of North Carolina at Chapel Hill has shown that psilocin, the active metabolite of psilocybin, may reduce alcohol consumption by calming stress-sensitive neurons in the central amygdala.

In female mice exposed to long-term alcohol use, psilocin dampened the hyperactivity of these neurons, temporarily reducing drinking.

Similar effects occurred in mice with milder alcohol exposure, aligning with clinical observations that psychedelics can improve emotional regulation across multiple disorders. The work offers an important mechanistic window into how psychedelic-based treatments may benefit alcohol use disorders and stress-related conditions.  Here’s more: https://www.jneurosci.org/content/early/2025/10/30/JNEUROSCI.0652-25.2025

atai Beckley announced positive topline results from its open-label extension study of its Phase 2b clinical trial of BPL-003 in patients with treatment-resistant depression (TRD).

Findings showed that a 12 mg dose of BPL-003 administered eight weeks after a 0.3 mg, 8 mg or 12 mg dose of BPL-003 was generally well-tolerated and provided additional rapid, clinically meaningful antidepressant effects, which were sustained for up to eight weeks.

The company is now scheduled to meet with the FDA at an End-of-Phase 2 meeting to align on clinical trial designs and other aspects of the Phase 3 development program. Management anticipates providing guidance on the Phase 3 clinical program in the first quarter of 2026 with Phase 3 clinical trial initiation in the second quarter of 2026, pending the outcome of the FDA meeting. Check it out: https://finance.yahoo.com/news/ataibeckley-announces-positive-topline-data-120000248.html

Did You Know?

Did you know that a technique called ‘mind captioning’ can generate descriptive sentences of what a person is seeing or picturing in their mind using a read-out of their brain activity?

The technique also offers clues for how the brain represents the world before thoughts are put into words. Researchers believe this might be able to help people with language difficulties, such as those caused by strokes, to better communicate. Check it out: https://www.science.org/doi/10.1126/sciadv.adw1464

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