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Boehringer Ingelheim recently announced that the US Food and Drug Administration (FDA) has granted BI 425809 Breakthrough Therapy Designation (BTD) for the treatment of cognitive impairment (CIAS) associated with schizophrenia
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The company also announced plans to launch an innovative phase III CONNEX clinical trial program to evaluate the safety and efficacy of BI 425809 in improving the cognition of adults with schizophrenia
This breakthrough therapy designation and the initiation of phase III clinical trials are based on the results of phase II clinical trials of 1346.
9
.
Studies have shown that BI 425809 can improve the cognitive function of adults with schizophrenia
Dr.
Vikas Mohan Sharma, Head of Central Nervous System, Retinopathy and Emerging Fields at Boehringer Ingelheim, said: “Cognition is about the basic aspects of daily life such as problem-solving, memory and attention
.
Therefore, finding solutions to cognitive impairment is Boehringer Ingelheim is a key area of mental health research
The FDA’s breakthrough therapy designation process is designed to accelerate the development and review of drugs for serious or life-threatening diseases, provided that preliminary clinical evidence shows that the therapy is expected to be significantly better than existing therapies in one or more clinically significant endpoints
.
The CONNEX clinical trial plan will use the disease-specific language biomarker technology provided by Aural Analytics, which will be seamlessly embedded in the VeraSci pathway platform, allowing researchers to have a more comprehensive understanding of the cognition of trial participants in addition to the conventional clinical outcome indicators
.
Dr.
Rich Keefe, Chief Executive Officer of VeraSci, said: "VeraSci is very pleased to participate in this landmark innovative trial for CIAS
.
In the face of this difficult-to-treat disease, innovative solutions are critical to achieving substantial progress
Daniel Jones, co-founder and CEO of Aural Analytics, said: "Interventions to improve the lives of patients are an important driving force for our first study of its kind in collaboration with Boehringer Ingelheim and VeraSci
.
Some symptoms of schizophrenia.
As part of CONNEX's overall clinical trial plan, Boehringer Ingelheim will also use VeraSci's Virtual Reality Capability Assessment Test (VRFCAT) as a key secondary endpoint
.
VRFCAT can detect significant improvements in patients' daily life functions, helping clinical trials to obtain more accurate results
In March this year, BI425809 for the treatment of cognitive impairment in patients with schizophrenia was approved by the Center for Drug Evaluation of the National Medical Products Administration.
