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atai Life Sciences Announces Successful Outcome of Phase 2a Biomarker Trial of RL-007 in Cognitive Impairment Associated with Schizophrenia
RL-007 was well tolerated and demonstrated a clinically meaningful pro-cognitive profile Changes in quantitative electroencephalogram (qEEG) were consistent
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[{"type":"text","content":"RL-007 was well tolerated and demonstrated a clinically meaningful pro-cognitive profile Changes in quantitative electroencephalogram (qEEG) were consistent with the results of a previous Phase 1 trial of RL-007 These results support the progression of RL-007 to a double-blind, placebo-controlled Phase 2 trial focused on cognition NEW YORK, Dec. 14, 2021 (GLOBE NEWSWIRE) -- atai Life Sciences (Nasdaq: ATAI) (\"atai\"), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced positive topline data from its Phase 2a study of RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS). The 32-patient, single-arm, single-blind study demonstrated a clinically meaningful pro-cognitive profile for RL-007, based on analysis of general cognition and episodic memory. Additionally, the trial showed changes in quantitative electroencephalogram (qEEG) that are consistent with previous results of a prior study of healthy volunteers. Together, the results support atai’s decision to progress RL-007 to a double-blind, placebo-controlled Phase 2 trial focused on cognition. The topline Phase 2a data showed dose-related improvements on exploratory cognitive endpoints. These included the Brief Assessment of Cognition in Schizophrenia, Symbol Coding Test (Symbol Coding) and Hopkins Verbal Learning Task (HVLT), focusing on general cognitive function and episodic memory, respectively.1,2 The dose-responsive improvement of Symbol Coding and HVLT replicated the previously observed cognitive bi-phasic dose response of RL-007. Importantly, Symbol Coding is a highly sensitive cognitive endpoint in CIAS patients, has a high correlation with patient outcome, and is a key component of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB™).3 In addition to the pro-cognitive effects, a dose dependent response in qEEG was observed, with the greatest increases seen in 20mg and 40mg doses of RL-007. The qEEG data demonstrated salient increases in amplitude in the alpha band (up to 17% increase in normalized, baseline adjusted band power) and in the alpha-slow wave index (up to 21% increase), both markers of alertness believed to correlate with aspects of cognition.4 Notably, these findings recapitulate promising results from a...