Atai and Beckley's Psychedelic Breakthrough: Merger Plans Advance on Positive Depression Study Results

Atai Life Sciences and Beckley Psytech have announced promising results from a Phase 2b study of their psychedelic drug mebufotenin, paving the way for their planned merger and advancement to Phase 3 trials. The nasal spray treatment for treatment-resistant depression has shown significant efficacy and safety, potentially positioning the companies at the forefront of the burgeoning psychedelic medicine market.

Study Success Bolsters Merger and Financing

The Phase 2b study results revealed that mebufotenin safely and significantly reduced symptoms of treatment-resistant depression. Following this announcement, Atai's shares surged by 20%, reflecting investor confidence in the drug's potential. The positive outcome has cleared the way for the companies to proceed with their merger plans, initially announced in June and contingent on these results.

Concurrent with the study announcement, Atai secured a $50 million private placement led by Ferring Ventures and Apeiron Investment, the family office of Atai's founder and Chairman Christian Angermayer. This influx of capital is expected to support the combined entity's push towards Phase 3 trials and potential commercialization.

Mebufotenin's Promising Clinical Profile

The Phase 2b study of mebufotenin demonstrated several key advantages:

• Efficacy: The drug showed a difference of 5.3 and 6.3 points for two therapeutic doses compared to a low-dose control group on a scale measuring depressive symptoms at Day 29 post-treatment.
• Rapid Onset: Improvements were observed as early as one day after treatment.
• Duration: Effects generally lasted at least eight weeks, suggesting potential for less frequent dosing compared to existing treatments.
• Safety: No serious side effects or evidence of suicidal intent or behavior were reported.
• Administration: Patients were generally able to leave the clinic within 90 minutes of treatment, aligning with conventional treatment windows.

The companies plan to advance the 8 mg dose into Phase 3 testing, citing equivalent efficacy between the 8 mg and 12 mg doses tested.

Positioning in the Psychedelic Medicine Landscape

Atai and Beckley's progress comes amid growing acceptance of psychedelic drugs for mental health treatment. Both Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin Makary have expressed support for the potential benefits of these medicines.

The success of mebufotenin positions Atai and Beckley favorably in comparison to competitors. Notably, Compass Pathways recently faced shareholder disappointment despite Phase 3 success, as their drug showed a mean difference of only 3.6 points compared to placebo on the depressive symptom scale.

As the pharmaceutical industry continues to explore psychedelic treatments, Atai and Beckley's merger and advancement of mebufotenin represent a significant development in addressing the critical need for effective therapies for treatment-resistant depression.