Boehringer Ingelheim's schizophrenia drug candidate has failed in clinical trials, leading to the discontinuation of further research.
Global pharmaceutical company Boehringer Ingelheim noted on the 16th (local time) that it could not confirm the targeted efficacy in the phase 3 clinical trial for the schizophrenia treatment candidate, 'Iclepertin,' which is accompanied by cognitive impairment.
Iclepertin was anticipated to be effective for schizophrenia with cognitive impairment due to its effect of inhibiting glycine transporter type 1 (GlyT1). The U.S. Food and Drug Administration (FDA) also designated Iclepertin as an innovative therapy for schizophrenia with cognitive impairment.
Boehringer Ingelheim had been implementing the clinical trial program 'CONNEX' to evaluate the efficacy of Iclepertin. CONNEX consisted of three phase 3 clinical trials aimed at confirming the cognitive impairment improvement effects and safety for adult schizophrenia patients.
1,840 participants took Iclepertin and a placebo for 26 weeks to assess the effects. However, Iclepertin showed no significant effects across all three clinical trials.
Boehringer Ingelheim stated, 'Iclepertin did not meet the primary and secondary endpoints,' but did not disclose specific evaluation metrics.
With the confirmation that Iclepertin has no effects, the long-term extension study (CONNEX-X) will also be discontinued. However, Iclepertin appears to have no significant issues regarding safety.
Shashank Deshpande, head of Boehringer Ingelheim's Pharmaceuticals Division, expressed disappointment at the clinical trial results but noted, 'Boehringer Ingelheim has more than 20 candidates in various disease areas, including schizophrenia and major depressive disorder,' adding, 'We look forward to the future development of these candidates.'