Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for BI 425809 for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). The company also announced the planned initiation of the innovative CONNEX Phase III clinical trial program assessing the safety and efficacy of BI 425809 for improving cognition in adults with schizophrenia. BI 425809, a novel glycine transporter-1 (GlyT1) inhibitor, forms a key component of Boehringer Ingelheim's Mental Health research program.

Together, this Breakthrough Therapy Designation and Phase III trial initiation is based on results from the Phase II 1346.9 clinical trial, which demonstrated that BI 425809 improved cognition in adult patients with schizophrenia[1]. Central to many everyday tasks, impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacological treatments are currently approved for CIAS.

"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, M.D., 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. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones and society."

The Breakthrough Therapy Designation process was established by the FDA to expedite the development and review of drugs for serious or life-threatening conditions where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

The CONNEX trial program will incorporate disease-specific speech biomarker technology from Aural Analytics that will be seamlessly embedded into VeraSci's Pathway platform to provide a richer picture of trial participants' cognition alongside more conventional clinical outcome measures. Additional information about the studies can be found at www.clinicaltrials.gov under the identifiers NCT04846868, NCT04846881, and NCT04860830.

"VeraSci is excited to take part in this landmark innovative trial in CIAS," said VeraSci CEO Dr. Rich Keefe. "Innovative solutions are imperative to making meaningful progress in this difficult illness. We are hopeful that this research will be an important step forward for the field."

"Interventions to improve patients' lives are a key driver for our partnership with Boehringer Ingelheim and VeraSci as part of this first-of-a-kind trial program," said Aural Analytics Co-Founder & CEO Daniel Jones. "Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions."

As part of the broader CONNEX trial programs, Boehringer Ingelheim will also use VeraSci's Virtual Reality Functional Capacity Assessment Test (VRFCAT), an assessment that improves clinical trials by detecting functionally meaningful improvements in patients' everyday lives, as a key secondary endpoint. The VRFCAT, which has been accepted into the FDA's Clinical Outcome Assessment Qualification program, simulates key instrumental activities of daily living (iADLs) in a realistic and interactive environment and demonstrates sensitivity to basic functional capacity deficits.