atai Life Sciences announced positive initial results from Beckley Psytech’s Phase 2a open label study of BPL-003 in Treatment Resistant Depression, a condition that affects approximately 100 million people worldwide. Initial analysis showed that a single dose of BPL-003 induced a rapid antidepressant response in 55% of patients on the day after dosing. The antidepressant effect was durable, with a 55% response rate maintained at week 4, which continued to week 12. There were 55% of patients in remission at week 4 and 45% in remission at week 12. These findings represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT. Commenting on the results, Florian Brand, Chief Executive Officer and Co-Founder of atai Life Sciences said: “We are thrilled with the progress the Beckley Psytech team has made on the BPL-003 program. The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year. With around half of TRD patients in remission three months after just a single dose of BPL-003 in this study, we are particularly excited about its antidepressant durability potential. The results indicate that BPL-003 could offer a scalable, single-dose administration within the two hour in-clinic treatment paradigm successfully established by Spravato.”
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