atai Life Science has released its most recent corporate update.
This chance to review the company’s entire development portfolio is timely, as just a few days ago atai released news that its most advanced drug candidate, PCN-101, did not meet the primary endpoint of its Phase 2a trial. Investors and the markets were not pleased and the stock has taken a beating (down 35% in the last 5 days).
Therefore this is an opportunity to take a step back and see the full breadth of atai’s diverse set of programs.
Here’s a look at some highlights of atai’s main development programs:
atai’s pipeline has been considered the most comprehensive in the industry. This chart shows an updated view of its most advanced programs, covering a range of compounds and conditions:
The PCN-101 results were disappointing because it was the firm’s most advanced trial. The bulk of atai’s other studies are still in earlier stages. This chart shows upcoming milestones and new programs moving into Phase 2:
In December, atai initiated a Phase 2b proof-of-concept trial of RL-007 for Cognitive Impairment Associated with Schizophrenia. The trial was initiated and has begun patient screening. There are currently no FDA-approved medications for CIAS, a major cause of disability in 80% of patients with schizophrenia1.
atai has dosed the first subject in their Phase 1
single-ascending dose (SAD) trial of VLS-01 with topline results expected in H1 2023. VLS-01 is a synthetic form of N,N-dimethyltryptamine (DMT) under development for treatment-resistant depression (TRD).
While PCN-101 “demonstrated signals of efficacy across all timepoints out to two weeks” — showing that the compound does have some positive effects on patient results — it did not show significant differences in efficacy from the placebo group. atai is reviewing the next steps for this once-promising program.
Just yesterday, GABA Therapeutics Announces Positive Final Results from Phase 1 Single and Multiple Ascending Dose Trial of GRX-917. The drug was well-tolerated and initiation of a GRX-917 efficacy study is anticipated in H1 2023 with results expected in 2024.
DMX-1002 is an oral formulation of ibogaine, a naturally occurring psychedelic product isolated from a West African shrub. Subjects have been dosed in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002) for the treatment of Opioid Use Disorder, with Phase 1 results expected in first half of 2023.
