Boehringer Ingelheim’s once-daily oral treatment for cognitive impairment in adults with schizophrenia failed to meet primary and key secondary endpoints in a phase 3 clinical program.
In the CONNEX program, which enrolled 1,840 patients, no statistically significant effects on cognition or functioning were observed in patients treated with iclepertin versus placebo at six months. The program comprised three clinical trials, all of which were randomized, double-blind, placebo-controlled parallel group trials investigating treatment with oral iclepertin 10 mg once daily over a 26-week period in adults with schizophrenia who received stable antipsychotic treatment.
Boehringer was hoping iclepertin, a glycine transporter 1 (GlyT1) inhibitor, would be the first approved targeted treatment for cognitive impairment in schizophrenia. Cognitive impairment is one of the three core symptom domains of schizophrenia, along with positive and negative symptoms.
In September 2024, Bristol Myers Squibb’s oral drug, Cobenfy, won approval to address the positive symptoms of schizophrenia, such as hallucinations and delusion, as well as the negative symptoms, including diminished emotional expression, speech, motivation, and pleasure. The approval made Cobenfy the first new drug for the disease in more than 30 years.
Following the iclepertin trial failures, Boehringer says it will discontinue the long-term extension trial, CONNEX-X, immediately.