Beckley Psytech’s psychedelic drug has successfully reduced the symptoms of depression in a phase 2 study, triggering the next stage of a planned merger with mental health-focused company Atai Life Sciences.
The phase 2b trial of 193 patients with treatment-resistant depression evaluated 8-mg and 12-mg doses of the drug, dubbed BPL-003, against a 0.3 mg comparator arm for eight weeks. BPL-003 is an intranasal formulation of mebufotenin or 5-MeO-DMT, a psychedelic substance belonging to the tryptamine family.
A single 12-mg dose of BPL-003 was shown to result in the “statistically significant” 11.1-point decrease in depression symptoms at Day 29 as measured on the the Montgomery-Åsberg Depression Rating Scale (MADRS), compared to a 5.8-point decrease for the comparator arm, hitting the primary endpoint of the trial.
Meanwhile, the 8-mg dose achieved a similar MADRS reduction of 12.1 points, which Atai said hit a key secondary efficacy endpoint for the study. As both doses appeared to demonstrate similar efficacy, Beckley and Atai suggested that the 8-mg dose “may be sufficient to achieve therapeutic benefit from a single dose.”
“Notably, both the 8 mg and 12 mg doses of BPL-003 showed statistically significant improvements in MADRS scores as early as one day after dosing, with effects generally maintained out to week 8,” the companies explained in a July 1 release.
When it came to safety, 99% of treatment-emergent adverse events were mild or moderate, said the companies, which noted that there were no drug-related serious adverse events nor suicide-related safety signals.
The results hit the criteria required for Atai to proceed with its planned merger with Beckley Psytech, which was first set out last month. Assuming the plan is signed off by Atai’s shareholders, the resulting company, to be named Atai Beckley, should “create a global leader in short-time in-clinic psychedelic-based mental health therapies,” the companies said in this morning’s release.
“The achievement of our primary and secondary endpoints in this study represents an important milestone in the development of BPL-003 and reinforces its potential to be a viable treatment option for patients and healthcare systems,” Beckley’s CEO Cosmo Feilding Mellen said in the release.
“We are particularly encouraged that a single 8 mg or 12 mg dose of BPL-003 showed rapid and durable efficacy results, favourable tolerability and a short time in-clinic, giving us important flexibility in optimising the design of future trials,” the CEO added. “We now look forward to preparing for end-of-phase 2 meetings with regulators and moving forward with our strategic combination with Atai Life Sciences.”
When it comes to nasal sprays for depression, Johnson & Johnson’s Spravato leads the way. The companies said the fact that the majority of patients in the phase 2 trial were deemed ready for discharge at the 90-minutes post-dose assessment “suggests BPL-003 could fit within the existing two-hour in-clinic interventional psychiatry treatment paradigm established by Spravato.”
“These findings strengthen our confidence in the potential of BPL-003 to be a transformative psychedelic therapy, offering rapid and durable antidepressive effects with minimal in-clinic time for patients with treatment-resistant depression,” Atai CEO Srinivas Rao, M.D., said in the release. “We look forward to engaging with the regulators later this year to advance this innovative treatment into phase 3 clinical development.”
The psychedelics sector received a high-profile setback last year when the FDA rejected Lykos Therapeutics’ application for approval of its MDMA therapy for post-traumatic stress disorder. But recent weeks have seen some good new emerge from the clinic, including a successful phase 3 depression readout for Compass Pathways’ psilocybin treatment.