atai Life Sciences 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™). 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 previous study of RL-007 in a human model of cognitive impairment utilizing a scopolamine challenge. This previous trial observed similar qEEG responses and changes in a word recall task within the same dose range. Recognify Life Sciences, an atai Life Sciences platform company, is conducting the current and upcoming RL-007 trials in CIAS.