- Mental health startup Cerebral has partnered with Alto Neuroscience for a clinical trial.
- The trial of a depression drug candidate is virtual and hopes to include 200 patients.
- Cerebral is a digital mental health startup that offers subscription-based therapy and medication.
Mental health startup Cerebral partners with Alto Neuroscience for an upcoming home-based clinical trial for biopharmaceutical company Alto’s
– drug candidate, according to federal records.
The idea behind this partnership is that Cerebral is a mental health company treating patients with depression, the condition for which Alto is developing treatments. Thus, the trial is able to bypass the time-consuming and costly step of trying to find the right testing cohort.
Cerebral, which was recently valued at $4.8 billion after a $300 million fundraising round from SoftBank, has data on the mood, medication history, location and demographics of its patients who are otherwise difficult to obtain. Generalist primary care companies tend to treat younger, healthier patients who are generally not potential drug candidates, often focusing on complex or chronic conditions.
Other companies that address specific populations, where the data they collect and the types of patients they work with are similar to Cerebral, are also likely to pursue similar partnerships, said Sari Kaganoff, chief consulting officer at Rock Health.
Kaganoff said other direct-to-consumer products
like Ro and Hims, who focus more on delivering care than collecting detailed patient data, were less likely to pursue a similar strategy by partnering with pharmaceutical companies for drug discovery or development, because they just didn’t have the right type or amount of data.
“You’ve brought together these kinds of patients, and a pharmaceutical company should be able to capitalize on that,” Kaganoff said. “That’s what I see here, it’s more opportunistic on the brain front.”
The objective of the trial is to determine how different patients respond to Alto’s Alto-300 PO tablet, a drug candidate in phase two development that aims to treat major depressive disorder using a specified set of biomarkers, hoping to identify some of the biomarkers in patients. who respond to the drug.
Cerebral’s chief medical officer, David Mou, told TechCrunch in December that the startup provided patients for the trial “in less than an hour.” It used patient data it already had, according to Mou, including prescription history and responses to the mood questionnaire. Mou also told TechCrunch that Cerebral may prescribe the drug to its members once it is approved.
“Frankly, we need to realize in the way we develop drugs that psychiatry has changed. The vast majority of care is delivered through remote interactions, so we need to design optimal studies for this way of approaching the patients,” said Alto CEO Amit Etkin. Initiated.
How Alto manages the trial
The trial with Cerebral does not include a control group, according to the filing. Etkin told Insider this was so the company could determine which patients had “robust” responses to the drug’s biomarkers. As the drug goes through additional trials, control groups will be added, Etkin said.
The proposed start date for the study was in December with a completion date in September. He hopes to recruit about 200 participants aged 18 to 74 with a diagnosis of severe major depressive disorder who has not responded to previous antidepressants.
Patients with suicidal ideation, liver failure, alcoholism or
are not eligible for the trial. The trial will be held virtually in multiple states, with in-person contact available in Atlanta, Dallas and New York.
Other digital health startups, including 23andMe, have pursued similar strategies using patient data to inform drug development with pharma companies like GlaxoSmithKline. 23andMe provided genetic information to GSK to help it explore options for an antibody drug that was not getting results. With this additional information, GSK was able to redesign its drug and embark on an early-stage clinical trial. 23andMe is not involved in the lawsuits.
Cerebral grows beyond its initial activity
Cerebral treats patients with mental health issues through digital therapy and medication management through a monthly subscription.
In 2020, he began treating moderate depression and anxiety, founder and CEO Kyle Robertson told Insider during his $35 million Series A fundraiser in November 2020. Since then, he has is extended to include the treatment of patients with addiction, attention disorders such as ADHD. , and trauma.
Patients can opt for different types of Cerebral subscriptions depending on their needs, such as a prescription-only subscription that includes quarterly checkups with a prescribing doctor or nurse practitioner and monthly checkups with the team of counselors. Cerebral care, who are not licensed therapists or medical professionals.
Alto Neuroscience is a biotech startup developing ways to measure brain activity that it says will lead to better-designed studies for mental health treatments. It launched publicly in October with initial funding of $40 million and Etkin, a former tenured professor of psychiatry at Stanford University, as CEO.
Etkin said the two companies would continue to work together, but declined to elaborate on whether the partnership would include trials or drug candidates.
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