A Deeper Look at atai Life Sciences’ Corporate Update

atai Life Science has released its most recent corporate update.

This chance to review the company’s entire development portfolio is timely, as investors look for some guidance after atai’s most advanced program, PCN-101, did not meet the primary endpoint of its Phase 2a trial.

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:

A summary of atai’s upcoming major milestones:

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 is the largest shareholder in Compass Pathways, with their much-anticipated Phase 3 trial for COMP360 just getting underway.

The PCN-101 results were disappointing, but atai has given some clarity on the program’s future:

PCN-101 (R-Ketamine for Treatment-Resistant Depression): atai will continue to support Perception’s development of PCN-101 through an additional IV-to-subcutaneous bridging study, which is currently on-track to be completed in the middle of 2023. In parallel, atai continues to work with Perception Neuroscience to explore strategic partnership options.

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).

GABA Therapeutics has announced 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.

Click here for a look at the complete pipeline update and stay tuned to Microdose for more on atai Life Sciences