The Food and Drug Administration (FDA) has granted BI 425809, an investigational glycine transporter-1 (GlyT1) inhibitor, Breakthrough Therapy status for the treatment of cognitive impairments associated with schizophrenia.
The designation is based on the results of the randomized, double-blind, placebo-controlled phase 2 study 1346.9 (ClinicalTrials.gov: NCT02832037), in which the efficacy and safety of 4 different doses of BI 425809 in adults with cognitive impairments related to schizophrenia was rated. Patients were randomized to receive either BI 425809 or placebo orally once daily for 12 weeks.
The results showed that treatment with BI 425809 resulted in an improvement in cognition, as measured by the composite total T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (primary endpoint) compared to placebo at 12 weeks .
The company will evaluate the efficacy and safety of BI 425809 in the CONNEX study program, which includes Phase 3 CONNEX-1 (ClinicalTrials.gov: NCT04846868), CONNEX-2 (ClinicalTrials.gov: NCT04846881) and CONNEX-3 (ClinicalTrials.) .gov: NCT04860830) Studies. As a secondary endpoint, the program will also use the Virtual Reality Functional Capacity Assessment Test, which simulates daily living activities in a realistic and interactive environment.
“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, so finding solutions to cognitive impairment is a key area of Boehringer Ingelheim Mental Health research,” said Vikas Mohan Sharma, MD, CNS Head of Medicine, Retinopathies & Emerging Areas, Boehringer Ingelheim. “This breakthrough therapy award underscores the urgent need for novel treatments for people with schizophrenia.”
Boehringer Ingelheim’s trial treatment for the treatment of cognitive impairment associated with schizophrenia has been granted Breakthrough Therapy status by the FDA. [press release]. Ridgefield, CT: Boehringer Ingelheim; 05/24/2021.
This article originally appeared on MPR