Boehringer updates on iclepertin Phase III schizophrenia program

Boehringer Ingelheim recently disclosed the outcomes of their Phase III CONNEX clinical program, aimed at addressing cognitive impairment in adults suffering from schizophrenia. The results revealed that the primary and key secondary objectives were not achieved, as there were no statistically significant improvements in cognition or functionality observed in patients treated with iclepertin compared to those given a placebo over a six-month duration. Despite these results, iclepertin, a glycine transporter 1 (GlyT1) inhibitor, was generally well tolerated, displaying a safety profile consistent with prior research.

Shashank Deshpande, a Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, expressed disappointment in the findings but reaffirmed the company's commitment to pursuing solutions for individuals with severe mental illnesses. He highlighted that Boehringer's pipeline includes over 20 investigational therapies at various stages of development, targeting conditions such as schizophrenia and major depressive disorder.

The CONNEX clinical program stands as the most extensive initiative to date focused on cognitive impairment associated with schizophrenia. Boehringer Ingelheim anticipates that the findings from this program will enhance scientific understanding and guide future research efforts in this field, which currently lacks approved pharmaceutical treatments. The comprehensive efficacy and safety data from the program are expected to be presented at an upcoming medical meeting.

Globally, schizophrenia affects about 24 million people, with cognitive impairment being one of the three primary symptom domains, alongside positive and negative symptoms. Cognitive challenges impact over 80% of those diagnosed with schizophrenia, often emerging early in life and significantly hindering daily functioning. These cognitive deficits can impede problem-solving, attention, and memory, complicating daily tasks and making it challenging for individuals to lead independent lives.

Currently, there are no approved pharmaceutical treatments specifically targeting cognitive impairment in schizophrenia. Iclepertin (BI 425809) was under investigation as a potential solution for this issue. The CONNEX program, structured to evaluate the safety and efficacy of iclepertin, included three randomized, double-blind, placebo-controlled trials. These trials involved administering 10 mg of oral iclepertin once daily over a 26-week period to adults with schizophrenia undergoing stable antipsychotic treatment. The extensive program enrolled 1,840 participants across 41 countries.

Following these results, Boehringer Ingelheim has decided to halt the long-term extension trial, CONNEX-X, with immediate effect. The company continues to be a leading figure in the biopharmaceutical sector, focusing on both human and animal health. As a major investor in research and development, Boehringer Ingelheim is dedicated to developing innovative therapies in areas with significant unmet medical needs. Established in 1885, the company remains independent, prioritizing sustainability throughout its operations. With over 53,500 employees serving in more than 130 markets, Boehringer Ingelheim is committed to fostering a healthier, more sustainable, and equitable future.