Boehringer Ingelheim recently announced that its product, BI 425809, has received Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for Cognitive Impairment Associated with Schizophrenia (CIAS). There are currently no approved pharmacological treatments for CIAS and if BI 425809 is successful, it could address this unmet need in the schizophrenia market. It is anticipated that BI 425809 will be launched in 2026 in the US, says GlobalData, a leading data and analytics company.

Christie Wong, Pharma Analyst at GlobalData, comments: “The current schizophrenia treatment landscape includes a high number of established atypical antipsychotic products that can effectively manage the positive symptoms of the disorder; however, there is a significant unmet need for novel effective treatment options for the negative symptoms and cognitive impairments seen in schizophrenia.”

As BI 425809 is the only pipeline drug in Phase III of development that has received BTD from the FDA, BI 425809 has the potential to become the first available pharmacological treatment for CIAS. However, BI 425809 will need to demonstrate in the CONNEX trial programme a strong safety profile and efficacy in improving cognition in adults with schizophrenia. The programme consists of three Phase III randomized, double-blind, placebo controlled parrel group clinical trials where patients receive a daily dose of BI 425809 over a 26-week treatment period. The estimated primary completion dates for these trials are in May 2024.

Wong added: “Pfizer’s PF-03463275 previously failed to demonstrate efficacy as an add-on therapy in patients with negative symptoms of schizophrenia when added to ongoing antipsychotic treatment. However, PF-03463275 is likely to compete directly with BI 425809 for CIAS indication due to its similar mechanism of action, targeting the sodium and chloride dependent glycine transporter 1 (Glyt1). Furthermore, both candidates are orally administered.

“PF-03463275 is currently in Phase II of development, with an estimated primary completion date in December 2021. As such, BI 425809 is anticipated to have the first-to-market advantage over PF-03463275.”