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Boehringer Ingelheim’s Investigational Treatment for Cognitive Impairment Associated with Schizophrenia receives FDA Breakthrough Therapy Designation

BI 425809, a novel glycine transporter-1 (Gly-T1) inhibitor to be Studied in First-of-its-Kind Phase III Trials, Incorporating Speech Analytics and Virtual Reality Functional Capacity Assessments.

Ingelheim, 25 May 2021 – 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 (Gly-T1) inhibitor, forms a key component of Boehringer Ingelheim’s Mental Health research program.

Together, this Breakthrough Therapy Designation and Phase III trial initiation are based on results from the Phase II 1346.9 clinical trial, which demonstrated that BI 425809 improved cognition in adult patients with schizophrenia1. 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 CIAS2.

“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 indicate 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 study can be found at under the identifier NCT04860830.

“VeraSci is excited to take part in this landmark innovative trial in CIAS,” says 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 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”, says Daniel Jones, Co-Founder & CEO from Aural Analytics. “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.

About CONNEX Trial Program
CONNEX is a Phase III clinical trial program designed to assess the safety and efficacy of BI 425809 for improving cognition in adults with schizophrenia. The program is comprised of three clinical trials, including CONNEX-1, CONNEX-2 and CONNEX-3, all of which are Phase III randomized, double-blind, placebo-controlled parallel group trial to examine the efficacy and safety of BI 425809 once daily over a 26-week treatment period in patients with schizophrenia. The primary outcome measure is change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive battery (MCCB). 

BI 425809 is an investigational compound and has not been approved by the US Food & Drug Administration or any other regulatory authority. Safety and efficacy have not been established.

Boehringer Ingelheim Mental Health
At Boehringer Ingelheim Mental Health, we are redefining mental health to enable people to thrive. We link behavior to the underlying neurobiology to develop targeted therapies that can ease the burden of these conditions, not just the symptoms. By combining traditional treatment approaches with new and innovative approaches and technologies, we will enable those with mental health conditions to create more meaningful connections to their lives, loved ones and society. 

About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.

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About VeraSci
VeraSci is a clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments. VeraSci brings scientific expertise, strategic innovation, and unwavering commitment to each project, helping clients worldwide develop novel therapies.

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About Aural Analytics
Aural Analytics is the industry’s leading speech neuroscience company building the world’s most advanced clinical-grade speech analytics platform for health applications across the lifespan. Its suite of applications and embeddable SDKs and APIs are available in up to 30 languages across Android, iOS, and the web are easy to use, secure, and provide robust, clinically relevant, interpretable, and validated metrics reflecting the neurological and respiratory health of its users.

For more information, please visit or follow Aural Analytics on Twitter, LinkedIn, Medium, and Facebook

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Last Updated: 26-May-2021