The companies will collaborate to develop targeted therapeutics for mental health conditions including depression and post-traumatic stress disorder. They are characterizing the concept as “precision psychiatry.”
Since the pandemic relegated much clinical research to a remote, home-based sphere, there’s been plenty of buzz around decentralization in clinical trials. The Cerebral/Alto partnership, however, represents one of the first attempts to study depression and other psychiatric disorders from afar.
Historically, drug development has focused on a curated sample of patients, making it difficult to translate the treatment to clinical practice once those drugs are in the real world. Addressing that issue is a primary motivator of the Cerebral/Alto initiative, according to Alto CEO Amit Etkin.
“It’s absolutely critical that, as we develop biomarkers to identify drug responders, we’re doing it in as real-world a fashion as possible,” he explained. “That means representing the population we hope to be treating geographically and socioeconomically. Because if we don’t develop drugs that way, they’re not going to work particularly well in the clinic.”
The partnership’s first trial, on a drug dubbed ALTO-300, will target individuals with depression who have not responded to at least one previous treatment. Patients will be monitored at their homes via a mobile EEG that can record their brain activity, behavioral tests to track cognitive and emotional functions, and wearables that track sleep patterns.
While the Cerebral/Alto team hasn’t disclosed the drug’s specific mechanism yet, it’s a circadian-focused intervention that the companies expect will have effects on sleep, activity patterns, depression, mood and motivation.
An obvious benefit of the trial’s decentralized design is speed. Researchers can analyze the data as it comes in and adapt trial design on the fly if needed.
“The advantages of going with the decentralized approach is you can get both larger scale and faster speed, which means more data that provides greater certainty around our development process,” Etkin noted.
Another benefit is the potential to close the gap in disparities in clinical research. Etkin expects Cerebral’s 200,000-strong patient database to serve as the foundation for their efforts to enroll a more representative population.
“You can much better represent geographies and subgroups of people, be it ethnic, racial or socioeconomic status, when you’re drawing from across the U.S.,” Etkin said. “Ultimately, we’re trying to break down barriers that prevent people from accessing trials and the kind of care we want to provide.”
The program with Cerebral, which launched two years ago and just last week announced $300 million in series C funding led by the SoftBank Vision Fund 2, is at the front of the imminent wave of trial decentralization spurred by the pandemic, Etkin added.
“A huge amount of value has been brought to bear through platforms like Cerebral and it has opened up the ability to do these trials in a way that’s never really been possible before,” Etkin said. “We’re wholesale embracing it.”
Cerebral and Alto plan to conduct additional studies that would each enroll 200 to 300 patients from Cerebral’s member network. The announcement comes amid a rising wave of mental health issues exacerbated by the COVID-19 pandemic.