Cognito Therapeutics Raises $50 million for Alzheimer’s Treatment Tech
June 28, 2022, STAT News, by Mario Aguilar - Cognito Therapeutics has raised $50 million in funding as it seeks to advance treatments for an elusive target: cognitive decline.
Cognito, based in Cambridge, Mass., is developing a headset that feeds a patient light and sound to drive changes in the brains of people with Alzheimer’s disease and other neurological conditions. Cognito will use the new funding from Menlo Park-based FoundersX to complete clinical trials it can submit to the Food and Drug Administration for approval. And with its new Silicon Valley connections comes a techy confidence that the company is sitting on a potential gold mine of data that could lead to a better understanding of the brain and how to treat the diseases that damage it.
“As we start to understand how patients interact with our exogenous stimulation, we’re going to build the world’s largest data set for understanding what’s necessary to personalize dose across and within patients over time,” said CEO Brent Vaughan. “And so there is the ability to build very large data network effects.”
Cognito sits somewhere between a traditional medical device firm and the growing number of companies making software products intended to treat medical conditions, sometimes called digital therapeutics. Unlike devices that deliver deep-brain stimulation, the company’s technology is non-invasively delivered through a device that resembles a pair of plastic wraparound sunglasses attached to minimalist headphones. For an hour each day, patients receive the headset’s precisely calibrated stimulus designed to reactivate electrical brain activity that’s gone dormant.
Later this year, Cognito will launch pivotal trials for its treatments for both Alzheimer’s and mild cognitive impairment. If all goes well, the company could submit to FDA by early 2025. Though Vaughan is unsure which regulatory pathway the company will pursue, he said he believes its products will need premarket approval, the FDA’s most challenging bar for medical devices.
Cognito TX's GammaSense Device
The company’s Alzheimer’s treatment received breakthrough device designation from the FDA following a study that showed improvements in memory and cognition in Alzheimer’s patients after treatment. MRIs showed promising physical signs of decreased brain deterioration, according to Vaughan.
Looking ahead, the company is planning to test treatments for traumatic brain injury, Parkinson’s disease, stroke, and multiple sclerosis.
“This is not a narrow chemistry platform,” said Vaughan. “We don’t just have a certain scaffold of molecules or we don’t just have a certain type of antibody. We have something that has broad effect.”
FoundersX managing partner Helen Liang said she’s confident Cognito’s technology represents a “fundamental breakthrough” that could slow the course of neurodegenerative diseases. Many of the treatments that have tried and failed targeted hallmark beta amyloid plaques found in the brain in an effort to curb the progression of the disease.
The business case for Cognito’s first products is obvious: Alzheimer’s impacts a tremendous number of people, and there has yet to be a blockbuster breakthrough in treatment. Liang said that if Cognito’s technology proves successful in clinical trials, it has the potential to own the market and to be quickly adopted in the absence of alternatives.
But unlike traditional biotech investors who might focus on a startup company’s potential focused on a single drug, Liang said that FoundersX wants “to capture the value of the data enabled by this device treatment as much as possible. We want to see that be a core part of their business model.”
FoundersX is proud to lead Cognito TX's B round, joined by renowned backers including Morningside Capital, AD Drug Foundation and others.
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