atai Life Sciences, a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, has officially announced positive topline results from Beckley Psytech’s Phase 2a open-label study of its BPL-003 therapeutic in regards to treating Alcohol Use Disorder (AUD).
According to certain reports, BPL-003 happens to be a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate, focused on delivering rapid and durable treatment effects from a single dose with a short in-clinic treatment time.
As for the study, it recruited a total of 12 patients with moderate to severe alcohol use disorder (AUD). The study went on to discover that a single dose of BPL-003, in combination with relapse prevention cognitive behavioral therapy, was able to achieve meaningful and sustained reduction in alcohol use and heavy drinking days (HDDs) among patients out to 12 weeks.
Before expanding any further upon the study’s results, we must take into how account how AUD is a medical condition where the patient’s ability to stop or control alcohol use despite adverse social, occupational, or health consequences is essentially impaired. If we go by the word of World Health Organization, more than 400 million people are currently suffering from AUD worldwide. WHO also claims around 3 million deaths each year are attributed to the harmful use of alcohol.
Now, to address the given problem, we do have available an assortment of pharmacological treatment options, none has actually shown to be optimally effective. As a result, many patients who actually wish to abstain from, or reduce, alcohol consumption do not achieve their treatment goal.
In response, during the course of this study, atai’s BPL-003 was able to cut down on the mean number of alcohol units consumed per day from 9.3 units to 2.2 units at Week 12.
Next up, we must dig into how the mean percentage of HDDs, defined as consuming seven or more units of alcohol per day for women and nine or more units of alcohol per day for men, declined from 56% to 13% at Week 12. Mean number of abstinent days also increased from 33% to 81% at Week 12.
Another detail worth a mention here is rooted in the fact that almost 50% of the patients were found to be successful in remaining completely abstinent through the 12-week study.
Among other things, we ought to mention that BPL-003 was well-tolerated, all adverse events (AEs) were reported as mild or moderate. In fact, a larger chunk of patients were deemed as ready for discharge in no more than two hours.
Moving forward, Beckley Psytech has expressed an intention to evaluate future development options for BPL-003 in substance use disorders. Apart from that, the underlying formulation is also being investigated for treatment resistant depression (TRD).
Thus far, in a Phase 2a TRD study, a single 10mg dose of BPL-003 produced a rapid antidepressant response across 55% of patients at Day 1, with 55% of patients in remission at Day 29 and 45% in remission at Day 85.
“We are encouraged by these exploratory results from Beckley Psytech, our strategic investment, which demonstrate the potential of short in-clinic psychedelic therapies to transform the treatment of substance use disorders,” said Dr. Srinivas Rao, CEO and Co-founder of atai. “The high rates of sustained abstinence in this study are particularly promising given the significant challenges patients with alcohol use disorder face in achieving and maintaining abstinence. These findings add to the growing body of evidence supporting the potential of BPL-003 in treating serious mental health disorders. We look forward to the Phase 2b data readout of BPL-003 in treatment-resistant depression.”
