Atai Update: Ketamine Trials Are Ongoing, Company Cuts 30% Workforce

The clinical-stage biopharma company atai Life Sciences ATAI founded in 2018 shared updates on the two clinical trials as well as its plan to streamline its workforce with significant layoffs. 

Trials For Treatment-Resistant Depression

atai is currently involved in two clinical trials which aim to develop new options for Treatment-Resistant Depression (TRD.)

The most advanced to date is COMPASS’ synthetic psilocybin program. Proprietary COMP360 in conjunction with psychological support has provided positive results in depressive symptom severity on its multisite Phase 2b trial and is now advancing towards two concurrent Phase 3 trials.

Recent news includes an acceleration of Pivotal Trial 1 (COMP 005) following already achieved results, with top-line data is expected in the summer of 2024.

The second of atai’s psychedelics program studies include R-ketamine PCN-101 and is led by its subsidiary Perception Neuroscience. After the Phase 2a study’s mixed results and an in-depth evaluation, atai has decided to continue supporting PCN-101’s development through an IV-to-subcutaneous bridging study.

While the trial is ongoing and set to be completed in mid-2023, both companies continue to explore strategic partnership options.

Corporate Reorganization

atai’s co-founder and CEO Florian Brand stated that following efforts to focus capital allocation to generate near-term “meaningful clinical readouts” as well as to optimize operational efficiency, the company reduced its team by approximately 30% .  

See also: Cybin Streamlines Organization As It Focuses On Clinical-Stage: Here's How The Market Responded

The majority of the cost savings are expected to result from a workforce reduction in general and administration and non-clinical development as well, extending atai’s cash runway into mid-2026.

The other two key clinical programs involve pro-cognitive neuromodulator for cognitive impairment associated with schizophrenia RL-007, which has previously been evaluated in over 500 participants and was well-tolerated and even showed pro-cognitive effects; and a deuterated version of anxiety drug etifoxine GRX-917, which was well tolerated in a Phase 1 trial and appears to be non-addictive.

Brand believes the recent first patient dosing in the Phase 2b study of RL-007 exemplifies the team’s execution capabilities and further announced an updated clinical strategy for GRX-917, including a direct progress into a Phase 2 study in patients with an anxiety disorder.

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