atai Life Sciences Initiates Phase 2b proof-of-concept trial of RL-007 for Cognitive Impairment Associated with Schizophrenia

December 19, 2022

• 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 impairment in personal, family, social, educational, occupational, and other important areas of life. For example, cross-sectionally, only 10% of patients with schizophrenia are employed in a competitive role2. Furthermore, they are 2 to 3 times more likely to die early compared to the general population3. 80% of people with schizophrenia suffer from cognitive impairments, which include poor learning and retention of verbal information, as well as the most consistent findings of executive functioning deficits and an impaired ability to encode and retain verbally presented information4.

“Schizophrenia is a debilitating neurological disease that can reduce life expectancy by almost 20 years. What’s worse is only about 30% of people with psychosis receive specialist mental health care,” commented atai Co-Founder and CEO Florian Brand. “The safety profile and positive pro-cognitive efficacy of RL-007 show promise for the significant unmet needs of people suffering from schizophrenia.”

“RL-007’s unique pharmacology as a GABA/nicotinic modulator, acute onset of action, and excellent tolerability profile differentiates it from competitor pipeline options,” stated Srinivas Rao, atai Co-Founder and Chief Scientific Officer. “It has the potential for complimentary use with antipsychotics. We look forward to the Phase 2b results anticipated H1 2024.”

About atai Life Sciences

atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai Life Sciences’ subsidiary, Recognify Life Sciences, is conducting this study. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients. atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.