Schizophrenia drug improves cognitive function in phase 2a trial

A single-arm, single-blind, phase 2a study of the neuromodulating drug RL-007, initiated by biopharmaceutical company atai Life Sciences, revealed its effectiveness in improving cognitive function and awareness in patients with schizophrenia.

“The impact of cognitive impairment in schizophrenia can be debilitating and limit the ability of patients to conduct everyday tasks,” Florian Brand, CEO and co-founder of atai Life Sciences, said in a press release. “These phase 2a results further reinforce our belief in RL-007 to provide benefit in this challenging condition.”

A total of 32 patients with schizophrenia participated in the trial and were divided into four eight-patient cohorts. The cohorts were each administered oral doses of 10 mg, 20 mg, 40 mg, and 80 mg of RL-007 three times per day. Participants were required to be prescribed a stable dosing regimen of antipsychotic medication, which remained unchanged through the course of the trial.

All participants were given four doses of placebo, followed by six doses of RL-007, without knowledge of the strength of each dose or the exact order in which they were given either the drug or a placebo.

Data from three specific cognitive tests showed improvement in patients’ overall cognitive function, as well as in aspects of memory, based on certain intervals of increased drug dosage. Additionally, the trial revealed positive changes in quantitative electroencephalogram readings consistent with results of a prior study conducted with volunteers without schizophrenia who were given the same dosages of the drug scopolamine.

“These exciting phase 2a results extend previously observed clinical activities of RL-007 to CIAS patients and support advancement to the next clinical trial, which will be designed to assess cognitive benefits in a double-blind, placebo-controlled manner,” Matthew Pando, PhD, CEO and co-founder of Recognify Life Sciences, a platform company of atai Life Sciences that is conducting the RL-007 trials, said in the release. “These results demonstrate RL-007’s potential in [cognitive impairment associated with schizophrenia], a major area of unmet patient need that presently lacks approved therapies.”

atai plans to commence a randomized, double-blind, placebo-controlled, proof-of-concept phase 2 study of the drug, involving multiple cognitive tests similar to the ones in the just-completed trial.