Mental health startup Cerebral has inked a partnership with Alto Neuroscience to bring clinical trials for depression to patients’ homes.
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 companies aim to conduct clinical trials of new drugs that can better match treatments with a person’s condition, an approach they called “precision psychiatry,” so patients feel better faster.
Cerebral and Alto plan to begin enrolling 200 patients in January.
It marks the first-ever clinical trial for depression that participants will participate in fully from home, eliminating barriers to access to mental health care that have plagued the U.S. healthcare system, especially during the pandemic. The trial will test the clinical-stage biopharmaceutical company's depression drug candidate, ALTO-300.
It comes at a time when more than 50 million people in the U.S. are living with a mental illness, including major depressive disorder and post-traumatic stress disorder (PTSD), and there is an urgent need to improve personalized care for these conditions. Stark evidence of this urgency is the continued rise of suicide rates in the U.S. over the last 20 years, especially among those aged 15-24, the companies said.
For the study, Cerebral will search its patient pool for people who haven't been helped by existing therapies in major depressive disorder and will provide access to Alto’s platform that considers an individual's unique biology in treatment. Data from the first phase 2 study within the collaboration are 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, CEO 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.”
Launched just two years ago, online mental health startup Cerebral is growing rapidly, propelled by increased demand for behavioral health care services during the COVID-19 pandemic. The San Francisco-based company just banked $300 million in a series C round led by the SoftBank Vision Fund 2 and backed by new and existing investors including Prysm Capital, Access Industries, WestCap Group and Artis Ventures.
Cerebral aims to be a one-stop shop for comprehensive, online mental health care and wellness. The company offers counseling, therapy and medication delivery and management online for mental and behavioral health conditions such as depression, anxiety, serious mental illnesses, substance use disorder and nutrition issues.
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. Participants will undergo in-home evaluations to measure their brain activity (using electroencephalography), 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 onset 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 the 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 future studies that will potentially support FDA approval of novel psychiatric medications and companion biomarker diagnostics, the companies said.
“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," said Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience, in a statement.
If successful, Cerebral and Alto's precision approach has the potential to disrupt the current treatment paradigm in mental health care, according to David Mou, M.D., chief medical officer of Cerebral.
"We look forward to bridging the gap between innovative drug discovery and commercial scalability in order to help millions suffering from mental illnesses," he said.