atai Life Sciences and Beckley Psytech seek further FDA approval after positive results from depression treatment study.
atai Life Sciences and Beckley Psytech announced positive data from a new proof-of-concept study investigating a two-dose induction regimen of BPL-003 in patients with treatment-resistant depression (TRD).
BPL-003 is an intranasal formulation of 5-MeO-DMT designed to treat TRD and alcohol use disorder.
Here’s what Beckley Psytech CEO Cosmo Feilding Mellen had to say about the results…
“These results underline BPL-003’s potential to offer a rapid, well-tolerated, and durable treatment option for patients with treatment-resistant depression. They suggest that a second dose of BPL-003 not only maintains, but potentially deepens, antidepressant effects while remaining well-tolerated. Importantly, the findings are consistent with results from earlier Phase 2a cohorts, including studies in patients who were taking antidepressants (SSRIs), where a single dose of BPL-003 produced rapid and sustained improvements for up to three months. Together with the results from our Phase 2b program, these data provide a strong foundation of evidence to design our Phase 3 program.”
atai and Beckley Psytech are now finalizing plans to engage with the FDA to discuss the design of the Phase 3 clinical trials for BPL-003 in patients with TRD. Pending FDA feedback, initiation of the Phase 3 clinical program is expected in the first half of 2026. Here’s more: https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-and-beckley-psytech-report-positive-phase-2a
A new study published in JAMA Psychiatry has indicated that sugary drinks may raise the risk of depression in women by disrupting the gut microbiome.
Researchers have discovered that high consumption of soft drinks is linked to both a greater likelihood of major depressive disorder and more severe symptoms, particularly among women. The effect appears tied to an increase in Eggerthella bacteria, which have been linked to depression in earlier studies. These findings suggest nutrition-based interventions could play a role in preventing or treating depressive disorders. Check it out: https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2839019
Researchers from the University of Illinois have found that severe flu infections in pregnant mice compromise both placental and brain barriers, allowing large molecules and fibrinogen (a protein that plays a crucial role in blood clotting) to reach the fetal brain.
These molecules accumulate in critical regions like the subventricular zone, where neural stem cells develop, raising concerns about long-term impacts the flu might have on neurodevelopment.
Researchers emphasize that not every infection leads to harm, but severity plays a key role in determining outcomes. Here’s more: https://www.sciencedirect.com/science/article/pii/S0889159125003034?via%3Dihub
Did you know that a green-Mediterranean diet can slow brain aging by altering key blood proteins linked to neurodegeneration?
Using MRI scans and proteomic profiling, researchers tracked nearly 300 participants over 18 months and found that diet significantly shaped the brain age gap. Two proteins, Galectin-9 and Decorin, emerged as strong indicators of accelerated brain aging but were reduced by the polyphenol-rich green-Mediterranean diet. These findings highlight the potential of diet-based strategies to modulate biological pathways tied to Alzheimer’s and age-related cognitive decline. Here’s more: https://www.clinicalnutritionjournal.com/article/S0261-5614(25)00235-3/fulltext