Atai Life Sciences And Merger Partner Set Up Psychedelic Depression Therapy With Encouraging Late-Stage Data

Atai Life Sciences (NASDAQ:ATAI) and Beckley Psytech Limited jointly announced topline results from the eight-week, quadruple-masked, dose-finding core stage of the Phase 2b trial of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in patients with treatment-resistant depression (TRD).

The study achieved its primary endpoint as well as all key secondary endpoints.

In June, the companies announced their plan to combine in an all-share transaction, subject to the pre-agreed Phase 2b success criteria for BPL-003 (mebufotenin benzoate).

The transaction is expected to close in the second half of 2025.

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Key Efficacy Findings:

At Day 29, a single 12 mg dose of BPL-003 demonstrated a statistically significant reduction in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), with a mean decrease of 11.1 points from baseline compared to a 5.8 point reduction in the 0.3 mg comparator group (p = 0.0038).

For the key secondary efficacy endpoints, a single 8 mg dose of BPL-003 also showed significant improvement at Day 29, with a mean MADRS score reduction of 12.1 points (p = 0.0025 for change vs. the 0.3 mg control). The 8mg and 12mg of BPL-003 showed statistically significant improvements in MADRS scores as early as one day after dosing, with these effects generally maintained through Week 8.

The 8 mg and 12 mg doses of BPL-003 demonstrated equivalent efficacy, suggesting the 8 mg dose may be sufficient to achieve therapeutic benefit from a single dose.

The difference in MADRS scores between the 8 mg and 12 mg doses versus the 0.3 mg dose were statistically significant in both active arms from as early as Day 2, with mean MADRS reductions from baseline of 8.8 points in the 8 mg group and 8.9 points in the 12 mg group observed at that timepoint, compared to a reduction from baseline of 3.9 points in the 0.3 mg group.

These mean reductions from baseline increased to 11.1 points in the 8 mg group and 10.8 points in the 12 mg group at Day 8.

A durable effect was also observed for both higher doses, with the 8 mg group showing a mean reduction of 10.8 points from baseline at Day 57 and the 12 mg group showing a mean reduction of 10.2 points from baseline compared with the 0.3 mg group (5.2 point reduction).

Key Safety Findings:

Safety and efficacy results from this study support the selection of the 8 mg dose of BPL-003 for advancement into Phase 3 clinical studies.

More than 99% of treatment-emergent adverse events (TEAEs) were mild or moderate; there were no drug-related serious adverse events (SAEs).

Dose-related increases in administration site discomfort, nausea, headache, blood pressure, and anxiety suggest that the 8mg dose was better tolerated than the 12mg dose.

No participants in the 8 mg or 12 mg arms had any instance of treatment-emergent suicidal intent or behaviour, indicating no suicide-related safety signal observed to date.

Follow-up in the study’s eight-week open-label extension (OLE) stage is ongoing.

The OLE study evaluates the safety and efficacy of a second 12 mg BPL-003 administered to patients eight weeks after dosing in the core study. Data from the OLE study is expected in the third quarter of 2025 and will provide additional insights into the safety and tolerability of repeat dosing, as well as the durability of BPL-003’s antidepressant effect.

Concurrently, on Tuesday, Atai Life Sciences announced the private placement of 18.3 million shares with a nominal value of €0.10 (approximately $0.11) and pre-funded warrants to purchase 4.6 million shares, with approximately $50 million in gross proceeds.

Price Action: ATAI stock was up 28.3% at $2.81 during the premarket session at the last check on Tuesday.

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