Investigators Share Baseline Data From Study on Iclepertin for Schizophrenia at APA Annual Meeting


The extension trial aims to address the cognitive impairment often observed in schizophrenia.




A poster at the 2024 American Psychiatric Association (APA) Annual Meeting discussed the baseline data from the CONNEX-X study, which delves into the potential of iclepertin (BI 425809), a glycine transporter-1 inhibitor, to address the cognitive impairment often observed in schizophrenia.1

According to the study’s researchers, cognitive deficits are a hallmark of schizophrenia and significantly impact functional outcomes for patients, yet effective pharmacological interventions remain elusive. Building on promising results from earlier phase 2 trials indicating iclepertin's ability to enhance cognition in schizophrenia, phase 3 trials are now underway. The current study, CONNEX-X (NCT05211947), serves as an extension trial aimed at gathering additional safety data regarding the long-term use of iclepertin in patients who have completed phase 3 trials.1

CONNEX-X represents a continued effort in this line of research. It is a multicenter, multinational, open-label, single-arm extension trial targeting individuals with cognitive impairment often observed in schizophrenia who successfully completed 26 weeks of treatment with either iclepertin 10 mg or a matching placebo in 1 of 3 phase 3 CONNEX parent trials (NCT04846868, NCT04846881, and NCT04860830). The trial aims to enroll approximately 1400 clinically stable outpatients who will receive daily treatment with iclepertin 10 mg for 1 year, regardless of whether they previously received iclepertin or placebo.1

Eligible participants are those who did not exhibit suicidal behavior or ideation, were not diagnosed with moderate/severe substance use disorder, and did not receive diagnoses other than schizophrenia during the parent trial and up to visit 1 of CONNEX-X. Patients with conditions preventing participation or experiencing significant decreases in hemoglobin levels are also excluded.1

The primary objective of CONNEX-X is to monitor the occurrence of treatment-emergent adverse events. Secondary endpoints include changes from baseline in the Clinical Global Impressions-Severity (CGI-S) scale and hemoglobin levels. Moreover, efficacy endpoints encompass changes in cognitive and functional assessments, such as the MATRICS Consensus Cognitive Battery (MCCB) overall composite T-score, the Schizophrenia Cognition Rating Scale (SCoRS) total score, and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) total times.1

As of the latest analysis, 460 patients have been enrolled and randomized from the parent trials, boasting a screening failure rate of 0% and an impressive rollover rate of approximately 80% as of August 30, 2023. Baseline assessments conducted on a subset of 249 patients as of August 09, 2023, revealed mean scores for MCCB (29.5 [12.7] overall composite T-score), SCoRS (37.7 [9.8] interviewer total score), and VRFCAT (32.9 [20.8] adjusted total time).1

“Patient enrollment rate from parent CONNEX trials to CONNEX-X has been stable to date,” the researchers reported. “This extension study will allow the examination of long-term safety and descriptive analyses of cognitive and functional endpoints of iclepertin in the treatment of CIAS, providing key evidence supporting its long-term use in chronic disorders such as schizophrenia.”

The poster was presented by Corey Reuteman-Fowler, PhD; Zuzana Blahova, PharmDr; Stephen R. Marder, MD; and Satoru Ikezawa, MD.

According to the World Health Organization, schizophrenia affects 24 million individuals, or 1 in 300 individuals.2 Are you interested in learning more about schizophrenia and its potential treatments? Explore some of the latest coverage on schizophrenia in Psychiatric Times®.

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Note: This article was prepared with the assistance of ChatGPT.


1. Reuteman-Fowler C, Blahova Z, Marder ST, Ikezawa S, Falkai P. CONNEX-X: an extension trial examining the long-term safety of iclepertin in patients with schizophrenia who completed phase II CONNEX trials. American Psychiatric Association Annual Meeting. Poster presentation. May 6, 2024. Accessed May 6, 2024.,%20May%2006,%202024

2. Schizophrenia. World Health Organization. January 10, 2022. Accessed May 6, 2024.,as%20many%20other%20mental%20disorders

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