--Collaboration born out of joint commitment to bridge the gap between drug discovery and development and commercial scalability in psychiatry--
--Approach expected to rapidly advance the development of novel, targeted medicines for psychiatric conditions--
--First-ever in-home clinical study of its kind maximizes inclusion and impact, with a focus on helping people with mental health conditions access the right treatment for them--
SAN FRANCISCO and LOS ALTOS, Calif., Dec. 16, 2021 – Cerebral, Inc. and Alto Neuroscience Inc. today announced a partnership to launch the first-ever decentralized clinical study in precision psychiatry, thereby accelerating the development and deployment of effective treatments in mental healthcare. Through the collaboration, Cerebral is able to offer its network of members the opportunity to participate in at-home clinical research utilizing Alto’s biomarker platform and targeted drug candidates. The study aims to serve Cerebral members who have been unresponsive to existing therapies in major depressive disorder by providing access to Alto’s precision approach that considers an individuals’ unique biology in treatment. Data from the first Phase 2 study within the collaboration is expected to read out by the end of 2022.
“Our team is deeply committed to bridging gaps in clinical care and reducing barriers to connecting our members with personalized mental health resources,” said Kyle Robertson, chief executive officer and founder of Cerebral. “This partnership builds on the momentum of our recent exponential growth and we will not stop until everyone, everywhere can access high-quality care. We are humbled to partner with Alto, another revolutionary company completely rethinking psychiatric care, to deliver innovative treatment options to those struggling with mental health conditions as we expand our in-house clinical trial capabilities.”
Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience added,“The days of relying on trial-and-error for treating mental health conditions are over. Psychiatry has been poised for disruption for decades, and this partnership represents our collective commitment to bring a vast network of patients access to the care they deserve. The introduction of this first-ever decentralized clinical trial in precision psychiatry broadens our formerly narrow view of drug discovery and development in mental health, allowing us to quickly deploy effective, accessible treatments in a way not previously possible.”
Under the terms of the collaboration, the companies expect to conduct multiple Phase 2 studies to evaluate the novel drug candidates being developed by Alto Neuroscience for various psychiatric conditions. Studies conducted under this collaboration are expected to each enroll between 200 and 300 participants from Cerebral’s 200,000+ member network. Participants will undergo in-home evaluations to measure their brain activity (using electroencephalography (EEG)), cognitive and emotional functions, sleep and activity patterns and genetics. Convenient remote assessments will be done throughout the duration of each study and a dedicated interdisciplinary healthcare team will conduct at-home visits at the beginning and conclusion of each trial.
In addition to the brain biomarker evaluations, patients will also be assessed on clinical outcomes, such as depression or PTSD scales, to evaluate the overall improvements. Alto will leverage their analytical approach to predicting patient outcomes to determine whether a certain biomarker best identifies patients who are most likely to benefit from the drug candidate being evaluated. The results from these studies are expected to inform the design and implementation of studies that will potentially support FDA approval of novel psychiatric medications and companion biomarker diagnostics.
“Delivering accessible, cutting-edge care is of utmost importance to us and we’re proud to offer our members at-home access to clinical research,” said David Mou, M.D., MBA, chief medical officer of Cerebral. “Working to match each member with the right medication for their unique biology is completely novel in psychiatry, and if successful, this precision approach will completely disrupt the current treatment paradigm in mental healthcare. As one of the largest mental health providers in the world, we look forward to bridging the gap between innovative drug discovery and commercial scalability in order to help millions suffering from mental illnesses.”
Adam Savitz,M.D., Ph.D., chief medical officer of Alto Neuroscience, added, “Our goal is to identify who is responsive to our investigational medicines to move quickly towards registration supportive studies. Ultimately, this accelerates our ability to develop targeted medicines more efficiently and help patients get better faster. This partnership represents the beginning of upending the nature of mental health clinical trials moving forward as we work to better serve a greater breadth of patients at an unprecedented speed.”
Cerebral’s mission is to improve access to long-term, high-quality mental health care to everyone who needs it. Unlike traditional mental health care, Cerebral is accessible, convenient, affordable, and free of stigma. With several full-service monthly subscription plans to choose from, members receive online access to prescribing providers, behavioral counselors, talk therapists, and nutritionists—all from the comfort of home, with medication delivered straight to their door. Cerebral was founded and launched in January 2020 and is now the fastest growing mental health company in history. For more information, visit getcerebral.com.
About Alto Neuroscience
Alto Neuroscience is pioneering precision psychiatry by developing targeted medicines to help patients get better faster. Differences in individuals’ biology impact how they respond to treatment. Alto’s human data-driven platform measures brain biomarkers including EEG activity and behavioral patterns, wearable data, genetics, and other factors, to match each patient with the right Alto therapy. The company’s clinical-stage pipeline includes drug candidates being studied in mental health conditions targeting cognition, emotion, and sleep processes. For more information, visit https://www.altoneuroscience.com or follow us on Twitter.