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Iclepertin Shows No Benefit for Cognitive Function in Schizophrenia

A Phase II clinical trial evaluating the efficacy of iclepertin (BI 425809), a glycine transporter-1 inhibitor, in treating cognitive impairment associated with schizophrenia (CIAS) showed no significant differences in cognitive outcomes compared to placebo. Findings were published in Schizophrenia Research: Cognition.

“To relieve the burden on patients and reduce the financial and social burden of illness, CIAS must be adequately treated,” said Phillip D. Harvey, PhD, Miller School of Medicine at the University of Miami, Florida, and co-authors. “However, there are currently no approved pharmacotherapies specifically targeting cognitive symptoms in schizophrenia.”

The double-blind, placebo-controlled, parallel-group trial included 200 patients aged 18–50 with schizophrenia on stable antipsychotic therapy. Participants were randomized to receive either iclepertin 10-mg or placebo once daily for 12 weeks, in addition to adjunctive at-home computerized cognitive training (CCT). The primary endpoint assessed the change from baseline in neurocognitive composite T-scores from the MATRICS Consensus Cognitive Battery (MCCB). Secondary endpoints included score change on the Schizophrenia Cognition Rating Scale (SCoRS), the Positive and Negative Syndrome Scale (PANSS), and functional performance via the Virtual Reality Functional Capacity Assessment Tool.

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At Week 12, measurements showed no significant differences between the iclepertin and placebo groups across all endpoints. Adverse events (AEs) were reported in 39 patients receiving iclepertin, with most AEs mild to moderate in nature.

“To our knowledge, this trial is the largest of its kind combining daily pharmacotherapy for CIAS with at-home CCT,” Harvey and co-authors concluded.

“Even though efficacy could not be demonstrated, the safety results of iclepertin 10-mg were consistent with previous clinical studies and no new risks were identified. Three multinational Phase III trials (CONNEX-1, −2, and − 3) are ongoing to further investigate the efficacy and safety of iclepertin in improving cognition and daily functioning (without utilizing an adjunctive CCT) in patients with schizophrenia.”

 

Reference

Harvey PD, McDonald S, Fu E, et al. Efficacy and safety of iclepertin (BI 425809) with adjunctive computerized cognitive training in patients with schizophrenia. Schizophr Res Cog. Published online December 14, 2024. doi: 10.1016/j.scog.2024.100340