APA

APA 2024: Update on study of iclepertin use in patients with schizophrenia

May 9, 2024

CONNEX-X is a multicenter, multinational, open label, single arm extension trial in patients with cognitive impairment associated with schizophrenia (CIAS) who completed 26 weeks of treatment with the glycine transporter-1 inhibitor iclepertin (10 mg) or matching placebo in one of three parent trials. The baseline data shared at the American Psychiatric Association’s Annual Meeting shows the study is on track with stable enrollment thus far.

• CONNEX-X aims to recruit ~1,400 clinically stable outpatients who will be treated daily with iclepertin 10 mg for 1 year, regardless of whether they previously received iclepertin or placebo.
• In total, 460 patients have been enrolled and randomized from the parent trials to date with 0% screening failures (~80% rollover rate, August 2023).
• Primary endpoint of the trial is occurrence of treatment-emergent adverse events. Secondary endpoints are change from baseline in the following: Clinical Global Impressions-Severity (CGI-S), hemoglobin levels, MATRICS Consensus Cognitive Battery (MCCB) overall composite T-score, Schizophrenia Cognition Rating Scale (SCoRS) total score, and Virtual Reality Functional Capacity Assessment Tool (VRFCAT) total times.

Source:

Reuteman-Fowler C, et al. CONNEX-X: an extension trial examining the long-term safety of iclepertin in patients with schizophrenia who completed phase II CONNEX trials. Poster P10-012. Presented at: American Psychiatric Association Annual Meeting; May 4-8, 2024; New York City, NY. 2024. https://s7.goeshow.com/apa/annual/2024/poster_search.cfm?session_key=0103B7BC-90B1-1C06-DFD2-2C023AB50518&session_date=Monday,%20May%2006,%202024