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atai Life Sciences Announces Key Clinical Pipeline and Corporate Updates
RL-007: First patient dosed in the on-going phase 2b study in cognitive impairment associated with schizophreniaGRX-917: Intention to progress GRX-917 into a
About this update from Ataibeckley Inc.
[{"type":"text","content":"RL-007: First patient dosed in the on-going phase 2b study in cognitive impairment associated with schizophreniaGRX-917: Intention to progress GRX-917 into a phase 2 study in an anxiety disorder as the next step in clinical developmentCOMP360: Recently announced acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program, with top line data now expected in the summer of 2024Corporate: As a result of our recent restructuring and pipeline updates, the company has extended its cash runway, which is now expected into 1H 2026 NEW YORK and BERLIN, March 06, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, provided key clinical pipeline and corporate updates. “The dosing of the first patient in the phase 2b study of RL-007 in CIAS earlier this quarter exemplifies the execution capabilities of our team as we advance our programs into later-stage clinical studies,” said Florian Brand, CEO and Co-Founder of atai. “Along these lines, we are excited to announce the updated clinical strategy for GRX-917. The compound will progress directly into a phase 2 study in patients living with an anxiety disorder to accelerate development and generate the robust clinical data needed to inform a potential future registration.” Mr. Brand continued, “As part of our efforts to further focus our capital allocation towards generating meaningful clinical readouts in the near-term and to optimize our operational efficiency, we reduced our team by approximately 30%. I am grateful for the dedication of the team members impacted by this decision and their contributions towards our mission.” Pipeline Updates RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS)) The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS. Initial results from this study are expected in the 2nd half of 2024.The phase 2b study is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 20mg and 40mg of RL-007 vs placebo in approximately 230 patients with CIAS. The primary endpoint of the US-based study is the MATRICS Consensus Cognitive Battery neurocognitive composite score at 6-weeks.RL-007 is an orally available compound that modulates cholinergic, glut...