Express | Effectively improve cognitive impairment, innovative therapy is recognized by FDA as a breakthrough therapy

▎ WuXi AppTec content team editor 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).

BI 425809 is a new type of glycine transporter-1 (GlyT1) inhibitor.

CIAS includes the ability to solve problems in daily life, memory and attention, and is the main burden of patients with schizophrenia.
There is currently no approved therapy.

Boehringer Ingelheim plans to initiate a phase 3 clinical trial of BI 425809 to evaluate the safety and effectiveness of the drug in improving the cognition of adults with schizophrenia.

It is worth mentioning that on March 24 this year, according to the official website of CDE, it has been approved for clinical use in China by default and is intended to be used for the treatment of cognitive symptoms of schizophrenia.

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.

The trial enrolled 509 patients, and the patients in the experimental group took BI 425809 at 2 mg, 5 mg, 10 mg or 25 mg orally once a day.

The primary endpoint is the change from baseline in the patient's MCCB overall comprehensive T-score (a neurocognitive efficacy assessment test for schizophrenia).

According to the dose assessment model, compared with placebo, the MCCB overall composite T score of the 10 mg and 25 mg dose groups changed the most from baseline, and the incidence of adverse reactions in each group was similar.

The test showed that BI 425809 can improve the cognitive ability of adult patients with schizophrenia.

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 abnormality of the glutamatergic pathway caused by the low function of N-methyl-D-aspartate receptor is one of the pathological causes of schizophrenia and Alzheimer's disease.

Image source: The Phase 3 clinical trial project planned by 123RF will consist of 3 clinical trials.

Some of the symptoms of schizophrenia are produced by cognitive and emotional processes and can be identified by interruptions in speech output.
The use of innovative speech analysis may help objectively evaluate the consequences of treatment.

This clinical trial will use an innovative technology platform to evaluate patients' speech biomarkers and other indicators related to daily life.

Boehringer Ingelheim central nervous system, retinopathy, and Dr.
Vikas Mohan Sharma, medical director of the emerging field, said:.
"The breakthrough therapy in patients with schizophrenia identified further emphasizes the urgent need for new therapies
by traditional treatment methods and new Combining innovative technologies, we are developing targeted therapies that will help reduce the burden of mental health problems and enable patients to establish more meaningful connections with their lives, loved ones, and society.

"Reference: [1] Boehringer Ingelheim's Investigational Treatment for Cognitive Impairment Associated with Schizophrenia Receives FDA Breakthrough Therapy Designation.
May 24, 2021, from -for-cognitive-impairment-associated-with-schizophrenia-receives-fda-breakthrough-therapy-designation-301297651.
html Note: This article aims to introduce medical and health research progress, not a treatment plan recommendation.

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