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$ATAI Life Sciences(ATAI.US$ Intranasal 5-MeO-DMT Clinical Trial Offers Hope For Treatment-Resistant Depression
Benzinga· 2 mins ago
Partners Beckley Psytech and atai Life Sciences (NASDAQ:ATAI) have jointly announced positive initial results from a Phase 2a study of Beckley's novel formulation of 5-MeO-DMT in Treatment Resistant Depression (TRD.)
See: Atai Invests $50M In Beckley Psytech For Short-Duration Psychedelics Development
BPL-003 is a synthetic and patent-protected benzoate salt formulation of 5-MeO-DMT (aka mebufotenin) designed for intranasal administration. The open-label study assessed safety, tolerability and efficacy of the compound at a single 10mg dose, alongside psychological support, in patients with moderate-to-severe TRD (who withdrew from concomitant antidepressants.)
The study's initial findings reflect treatment of 11 participants, who were followed for 12 weeks post-dosing. Efficacy was assessed using the widely known and accepted Montgomery–Åsberg Depression Rating Scale (MADRS.)
The single 10mg dose resulted in a rapid onset and durable antidepressant effect in patients with TRD, which affects approximately 100 million people worldwide. Importantly, these findings are believed to represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT.
Specifically:
BLP-003's single dose induced a rapid antidepressant response in 55% of patients on the day after dosing. The antidepressant effect lasted, with a 55% response rate maintained at Week 4 and further on to Week 12.
55% of patients were in remission at Week 4, and 45% in remission at Week 12.
BPL-003 showed a good safety profile and was well tolerated. Adverse events (AEs) were predominantly mild or moderate and the most common AEs (>10%) were nasal discomfort, headaches, nausea and vomiting, broadly consistent with Phase 1 findings. No serious AEs were reported.
Acute effects resolved on average in less than two hours.
Altogether, data suggest BPL-003 could offer a shorter in-clinic treatment time vs. other psychedelic treatments in development.
Benzinga· 2 mins ago
Partners Beckley Psytech and atai Life Sciences (NASDAQ:ATAI) have jointly announced positive initial results from a Phase 2a study of Beckley's novel formulation of 5-MeO-DMT in Treatment Resistant Depression (TRD.)
See: Atai Invests $50M In Beckley Psytech For Short-Duration Psychedelics Development
BPL-003 is a synthetic and patent-protected benzoate salt formulation of 5-MeO-DMT (aka mebufotenin) designed for intranasal administration. The open-label study assessed safety, tolerability and efficacy of the compound at a single 10mg dose, alongside psychological support, in patients with moderate-to-severe TRD (who withdrew from concomitant antidepressants.)
The study's initial findings reflect treatment of 11 participants, who were followed for 12 weeks post-dosing. Efficacy was assessed using the widely known and accepted Montgomery–Åsberg Depression Rating Scale (MADRS.)
The single 10mg dose resulted in a rapid onset and durable antidepressant effect in patients with TRD, which affects approximately 100 million people worldwide. Importantly, these findings are believed to represent the longest known follow-up of depression outcomes in a clinical study of 5-MeO-DMT.
Specifically:
BLP-003's single dose induced a rapid antidepressant response in 55% of patients on the day after dosing. The antidepressant effect lasted, with a 55% response rate maintained at Week 4 and further on to Week 12.
55% of patients were in remission at Week 4, and 45% in remission at Week 12.
BPL-003 showed a good safety profile and was well tolerated. Adverse events (AEs) were predominantly mild or moderate and the most common AEs (>10%) were nasal discomfort, headaches, nausea and vomiting, broadly consistent with Phase 1 findings. No serious AEs were reported.
Acute effects resolved on average in less than two hours.
Altogether, data suggest BPL-003 could offer a shorter in-clinic treatment time vs. other psychedelic treatments in development.
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