Beckley Psytech, a UK-based developer of psychedelic medications, has announced positive findings from its phase 2 trial of BPL-003, a treatment for individuals with treatment-resistant depression (TRD). The trial involved 12 participants who received a single dose of BPL-003 alongside their existing selective serotonin reuptake inhibitor (SSRI) medication.
BPL-003 is an intranasal formulation containing 5-MeO-DMT benzoate, a psychoactive substance derived from various plant species and the Colorado River toad. Results indicated that the drug produced rapid antidepressant effects, lasting up to three months post-administration, and was well-tolerated by participants. The treatment was administered in a controlled environment with psychological support, allowing patients to be discharged within a few hours after dosing.
The open-label phase 2a study focused on individuals with moderate to severe depression who had not responded to at least two previous treatments. Results showed an average reduction of 18 points on the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline the day after dosing, with reductions of 19 points after one month and 18 points after three months.
These findings corroborate earlier results from Part 1 of the study, which were reported last year. Beckley Psytech noted that no serious adverse effects were observed among the participants. The company is now awaiting initial data from a larger phase 2b study involving 196 subjects, expected in mid-2025. This study will evaluate two doses of BPL-003 (8mg and 12mg) and include a lower dose (0.3mg) as an active placebo, with assessments occurring at four and eight weeks.
Analysts from Jefferies believe that the new data from the phase 2a trial represents a positive development for Beckley, suggesting consistent effects of BPL-003 across multiple studies and reducing risks for the ongoing phase 2b trial. A successful outcome in this larger study could lead to a pivotal phase 3 trial.
Dr. Rob Conley, Beckley’s chief scientific and medical officer, expressed optimism regarding the results, stating that they validate the safety and efficacy of combining BPL-003 with SSRIs. He emphasized the importance of understanding how various treatments interact, particularly since managing depression often involves multiple interventions. This approach could help minimize withdrawal symptoms for patients continuing on SSRIs and broaden access to treatment.
In addition to BPL-003, other psychedelics such as psilocybin, LSD, MDMA, and mescaline are also being investigated as potential treatments for TRD. With approximately 300 million people worldwide living with depression, and a third of those not responding to conventional antidepressants, the need for effective new treatments remains critical.
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