Overview
Beckley Psytech, now combined with atai Life Sciences as AtaiBeckley, develops psychedelic compounds like intranasal BPL-003 (mebufotenin benzoate, a 5-MeO-DMT formulation) for treatment-resistant depression and other psychiatric disorders. Their Phase IIb trial demonstrated significant MADRS score reductions of 11.1-12.1 points versus 5.8 in controls, with rapid onset within days and durability up to two months. The company plans Phase III advancement and regulatory engagement with the FDA.
Frequently asked questions
- What is Beckley Psytech's lead product candidate?
- BPL-003, an intranasal formulation of mebufotenin benzoate (5-MeO-DMT), for treatment-resistant depression, showing significant symptom reduction in Phase IIb trials.
- What are the clinical trial results for BPL-003?
- Phase IIb trial met primary endpoint with 11.1-12.1 point MADRS reductions versus 5.8 in low-dose control, rapid effects within 2 days, durable for at least 2 months, well-tolerated at 8mg dose.
- What is the regulatory and development status?
- Advancing 8mg BPL-003 to Phase III after Phase IIb success; planning FDA engagement for pivotal trials; ongoing open-label study for second-dose data expected Q3 2025.