atai Life Sciences and Beckley Psytech’s psychedelic medicine will progress to Phase III following its mid-stage success in treatment-resistant depression (TRD).
This follows the positive results of the Phase IIa study (NCT05660642), which found that an 8mg dose of mebufotenin benzoate nasal spray offered a 13.3-point reduction in depression scores from baseline at day two. This effect was maintained eight days after treatment, with patients experiencing a mean 12.9-point improvement by this time.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Depression scores in this trial were determined by the Montgomery-Åsberg Depression Rating Scale (MADRS), which is commonly used to classify symptom severity in depression clinical trials.
Though a singular dose of the psychedelic – otherwise known as BPL-003 – was proven to be efficacious, a second dose further enhanced these effects, slashing MADRS scores by 19.0 from baseline. This reduced slightly to a 13.7-point reduction from baseline after 12 weeks.
The subsequent dose was also linked to better response rates in patients, with the percentage of patients in remission nearly doubling from 25% to 50% four weeks after the second dose.
Though atai and Beckley have not released specific Phase IIa safety data for intranasal mebufotenin benzoate, the pair noted that the drug was well tolerated, with all reported treatment-emergent adverse events (TEAEs) classified as mild to moderate.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataPatients given the drug also met the discharge readiness criteria within two hours after dosing for both the 8mg and 12mg doses, which atai believes could facilitate the drug’s integration into the “established interventional psychiatric treatment paradigm”.
Following the promising results of this Phase IIa trial, atai and Beckley plan to discuss optimal dosing approaches, as well as the Phase III trial design for BPL-003 in TRD, with the US Food and Drug Administration (FDA). If all goes to plan, the pivotal trial will begin in H1 2026.
The biotechs are also keenly awaiting the results from the open-label extension (OLE) of their Phase IIb trial on mebufotenin benzoate, which is assessing the impact of a 12mg dose of the drug eight weeks after an initial dose. Data for this study are due to be released in October 2025.
It appears that investors mirror the pair’s excitement, as atai’s stock value jumped by 12% from $4.98 at market close on 22 September to $5.61 at market close on 23 September after the news. As Beckley Psytech is a privately held company, its value is currently unknown.
The race for psychedelic approval
In recent years, the pharmaceutical industry has taken a shine to psychedelic therapies, which have shown potential in a wide range of mental health conditions – from TRD to post-traumatic stress disorder (PTSD) and anxiety.
This comes at a time when the World Health Organisation (WHO) estimates that one billion individuals worldwide live with mental health disorders, including depression, highlighting the need for effective therapeutic options in certain patient subgroups.
Though psychedelics show promise, trial-related challenges have plagued the development of the drug class, with high patient expectations and functional unblinding (where a patient is aware they are under the influence of the drug) making it difficult for companies to get therapies over the line. Because of this, no psychedelic drug has yet received FDA approval.
However, the rocky road to approval has not completely deterred developers, as there are currently 13 planned or ongoing Phase III studies in TRD exploring the efficacy of psychedelics.
This includes Compass Therapeutics’ synthetic psilocybin, which hit its primary endpoint in a Phase III trial, as well as various trials involving Pfizer’s Esketamine (esketamine hydrochloride) and Molteni Farmaceutici’s Ketamine (ketamine hydrochloride).
