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

CONFERENCE REPORTER

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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Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of psychiatric disorders at psychiatrictimes.com.

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

References

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. https://s7.goeshow.com/apa/annual/2024/poster_search.cfm?session_key=0103B7BC-90B1-1C06-DFD2-2C023AB50518&session_date=Monday,%20May%2006,%202024

2. Schizophrenia. World Health Organization. January 10, 2022. Accessed May 6, 2024. https://www.who.int/news-room/fact-sheets/detail/schizophrenia#:~:text=Schizophrenia%20affects%20approximately%2024%20million,as%20many%20other%20mental%20disorders