The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to BI 425809, an investigational glycine transporter-1 (GlyT1) inhibitor, for the treatment of cognitive impairment associated with schizophrenia.

The designation is based on results from the randomized, double-blind, placebo-controlled phase 2 1346.9 trial (ClinicalTrials.gov: NCT02832037), which evaluated the efficacy and safety of 4 different doses of BI 425809 in adults with cognitive impairment associated with schizophrenia. Patients were randomly assigned to receive either BI 425809 or placebo orally once daily for 12 weeks.

Findings showed that treatment with BI 425809 led to improvements in cognition, as measured by the overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (primary endpoint), compared with placebo at 12 weeks.

The Company will evaluate the efficacy and safety of BI 425809 in the CONNEX trial program, which includes the phase 3 CONNEX-1 (ClinicalTrials.gov: NCT04846868), CONNEX-2 (ClinicalTrials.gov: NCT04846881), and CONNEX-3 (ClinicalTrials.gov: NCT04860830) studies. The program will also use the Virtual Reality Functional Capacity Assessment Test, which simulates activities of daily living in a realistic and interactive environment, as a secondary endpoint.


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“Cognition is a fundamental aspect of everyday life, including problem solving, memory and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim Mental Health research,” said Vikas Mohan Sharma, MD, Head of Medicine CNS, Retinopathies & Emerging Areas, Boehringer Ingelheim. “This Breakthrough Therapy Designation further highlights the urgent need for novel treatments for people living with schizophrenia.” 

Reference

Boehringer Ingelheim’s investigational treatment for cognitive impairment associated with schizophrenia receives FDA Breakthrough Therapy designation. [press release]. Ridgefield, CT: Boehringer Ingelheim; May 24, 2021.