Eli Lilly has completed its acquisition of AtaiBeckley, a US-based clinical-stage biopharmaceutical company developing rapid-acting neuroplastogens for mental health conditions, including BPL-003, its lead investigational programme for treatment-resistant depression (TRD).
Following the completion of the transaction, AtaiBeckley has become a wholly owned subsidiary of Lilly. The acquisition was approved by AtaiBeckley shareholders at a special meeting held prior to the closing of the transaction.
“Treatment-resistant depression persists even after multiple treatment attempts, leaving millions of people still searching for relief,” said Carole Ho, executive vice president and president of Lilly Neuroscience.
“AtaiBeckley’s neuroplastogens have the potential to open a new paradigm of treatment, with rapid-acting therapeutics designed to move away from chronic dosing. It’s the innovation this field needs, and we are committed to advancing them for patients who need more options,” Ho added.
BPL-003 Phase 2a data
In an open-label Phase 2a study, BPL-003 was evaluated for safety, efficacy and pharmacokinetics following a single dose in 12 patients with moderate-to-severe depression who had failed to respond to at least two prior depression treatments and were taking one of four selective serotonin reuptake inhibitors (SSRIs): citalopram, escitalopram, sertraline or fluoxetine.
Patients were followed for 12 weeks after dosing, with assessments conducted at multiple time points. Efficacy was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS).
A single intranasal dose of BPL-003 was associated with a rapid antidepressant effect, with a mean reduction of 18 points in MADRS scores from baseline on the day after dosing. The reduction was 19 points at one month and 18 points at three months after dosing.
BPL-003 was reported to be well tolerated. All adverse events were mild or moderate in severity, with no serious adverse events reported.
In a separate open-label Phase 2a study, 10 mg of BPL-003 was evaluated in patients with TRD who were not taking concomitant antidepressants.
A single administration resulted in a rapid antidepressant effect, with 55% of patients achieving a 50% or greater improvement in depression symptoms on day two, the day after dosing.
The study also reported a sustained antidepressant effect, with 55% of patients meeting remission criteria on day 29 and 45% remaining in remission on day 85.
BPL-003 was administered with a relatively short clinic stay, with patients considered ready for discharge within an average of less than two hours. According to the company, this could support a scalable treatment model that, if approved, could fit within the existing interventional psychiatry treatment paradigm.
