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atai Life Sciences Initiates Phase 2b proof-of-concept trial of RL-007 for Cognitive Impairment Associated with Schizophrenia
The phase 2b proof-of-concept trial will evaluate the novel compound, RL-007, for pro-cognitive effects in patients with Cognitive Impairment Associated with
About this update from Ataibeckley Inc.
[{"type":"text","content":"The phase 2b proof-of-concept trial will evaluate the novel compound, RL-007, for pro-cognitive effects in patients with Cognitive Impairment Associated with Schizophrenia (CIAS).The trial was initiated and has begun patient screening this month with first-patient-in anticipated by end-of-year.There are currently no FDA-approved medications for CIAS, a major cause of disability in 80% of patients with schizophrenia1.Topline results are expected in the first half of 2024. NEW YORK and BERLIN, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Today, atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced the initiation of its Phase 2b proof-of-concept clinical trial for RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS), a condition for which there are currently no FDA-approved treatments. The Phase 2b trial is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 2 doses of RL-007 and a placebo among 234 patients. The trial includes a 6-week treatment period with the MATRICS Consensus Cognitive Battery (MCCB) as the primary endpoint. The MCCB has been supported by the FDA as an approvable endpoint for CIAS. The trial will be conducted in the US, and patient screening is currently underway. RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in ten clinical studies, including one in the CIAS indication, with over 500 unique participants dosed to-date. In December 2021, atai announced positive biomarker data from a Phase 2a proof-of-mechanism study designed to evaluate the effects of RL-007 on safety, tolerability, electroencephalogram-based biomarkers, and cognition. RL-007 was well tolerated and demonstrated a clinically meaningful pro-cognitive profile consistent with previous Phase 1 and Phase 2 trials of this compound. These results supported the progression of an RL-007 Phase 2b proof-of-concept trial with the goal of demonstrating the pro-cognitive effect of RL-007 in CIAS. Schizophrenia affects approximately 24 million people worldwide. The disease is frequently associated with significant distress and impairm...