Innovative therapy to effectively improve cognitive impairment was recognized as a breakthrough therapy by the FDA

On May 24, 2021, Boehringer Ingelheim (Boehringer Ingelheim) announced that the US FDA has granted an oral investigational therapy BI 425809 Breakthrough Therapy Designation (BTD) for the treatment of schizophrenia-related cognitive impairment (CIAS) .

This breakthrough therapy designation and the initiation of the Phase 3 clinical trial project CONNEX are based on the results of a randomized, double-blind, placebo-controlled Phase 2 clinical trial.

BI 425809 is a new type of Gly-T1 inhibitor developed by Boehringer Ingelheim, which aims to improve the function of N-methyl-D-aspartate (NMDA) receptors by inhibiting Gly-T1, thereby acting as a treatment effect.

The planned Phase 3 clinical trial project will consist of 3 clinical trials.

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Reference materials:

[1] Boehringer Ingelheim's Investigational Treatment for Cognitive Impairment Associated with Schizophrenia Receives FDA Breakthrough Therapy Designation.

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