Atai Life Sciences ATAI and Beckley Psytech Restricted collectively introduced topline outcomes from the eight-week, quadruple-masked, dose-finding core stage of the Part 2b trial of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in sufferers with treatment-resistant despair (TRD).
The examine achieved its main endpoint in addition to all key secondary endpoints.
In June, the businesses introduced their plan to mix in an all-share transaction, topic to the pre-agreed Part 2b success standards for BPL-003 (mebufotenin benzoate).
The transaction is predicted to shut within 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 vital discount in depressive signs, as measured by the Montgomery-Åsberg Melancholy Score Scale (MADRS), with a imply lower of 11.1 factors from baseline in comparison with a 5.8 level discount within the 0.3 mg comparator group (p = 0.0038).
For the important thing secondary efficacy endpoints, a single 8 mg dose of BPL-003 additionally confirmed vital enchancment at Day 29, with a imply MADRS rating discount of 12.1 factors (p = 0.0025 for change vs. the 0.3 mg management). The 8mg and 12mg of BPL-003 confirmed statistically vital enhancements in MADRS scores as early as someday after dosing, with these results usually maintained via Week 8.
The 8 mg and 12 mg doses of BPL-003 demonstrated equal efficacy, suggesting the 8 mg dose could also be ample to attain therapeutic profit from a single dose.
The distinction in MADRS scores between the 8 mg and 12 mg doses versus the 0.3 mg dose had been statistically vital in each energetic arms from as early as Day 2, with imply MADRS reductions from baseline of 8.8 factors within the 8 mg group and eight.9 factors within the 12 mg group noticed at that timepoint, in comparison with a discount from baseline of three.9 factors within the 0.3 mg group.
These imply reductions from baseline elevated to 11.1 factors within the 8 mg group and 10.8 factors within the 12 mg group at Day 8.
A sturdy impact was additionally noticed for each greater doses, with the 8 mg group exhibiting a imply discount of 10.8 factors from baseline at Day 57 and the 12 mg group exhibiting a imply discount of 10.2 factors from baseline in contrast with the 0.3 mg group (5.2 level discount).
Key Security Findings:
Security and efficacy outcomes from this examine assist the collection of the 8 mg dose of BPL-003 for development into Part 3 medical research.
Greater than 99% of treatment-emergent adversarial occasions (TEAEs) had been delicate or reasonable; there have been no drug-related critical adversarial occasions (SAEs).
Dose-related will increase in administration web site discomfort, nausea, headache, blood stress, and nervousness recommend that the 8mg dose was higher tolerated than the 12mg dose.
No individuals within the 8 mg or 12 mg arms had any occasion of treatment-emergent suicidal intent or behaviour, indicating no suicide-related security sign noticed to this point.
Observe-up within the examine’s eight-week open-label extension (OLE) stage is ongoing.
The OLE examine evaluates the protection and efficacy of a second 12 mg BPL-003 administered to sufferers eight weeks after dosing within the core examine. Knowledge from the OLE examine is predicted within the third quarter of 2025 and can present further insights into the protection and tolerability of repeat dosing, in addition to the sturdiness of BPL-003’s antidepressant impact.
Concurrently, on Tuesday, Atai Life Sciences introduced the personal placement of 18.3 million shares with a nominal worth of €0.10 (roughly $0.11) and pre-funded warrants to buy 4.6 million shares, with roughly $50 million in gross proceeds.
Worth Motion: ATAI inventory was up 28.3% at $2.81 throughout the premarket session on the final examine on Tuesday.
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