Cognito Therapeutics (Boston and San Francisco) won FDA breakthrough designation in January for its lead product, a non-invasive neurostimulation device that uses visual and auditory stimulation technology to treat Alzheimer’s disease and other neurodegenerative disorders.
The breakthrough program will give Cognito priority review and greater communication with the FDA about device development and clinical trial protocols, through to commercialization decisions.
MIT brain and cognitive sciences professors Li-Huei Tsai and Ed Boyden launched Cognito Therapeutics in 2016. The company recently reported the results of a pair of small clinical studies.
The Phase 2 Overture study enrolled 76 patients with mild to moderate Alzheimer’s disease, randomized to receive either gamma frequency neuromodulation or a placebo over a six-month period. Investigators evaluated cognitive and functional abilities and brain volumetric changes. Over the 6-month period, patients in the treatment group exhibited an 84% slowing of functional decline in scores on the ADCS-ADL Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale (ADCS-ADL) as well as an 83% slowing in memory and cognitive decline as measured by Mini-Mental State Exam (MMSE) scores compared to sham. Overture study investigators found that the treatment resulted in a 61% reduction in whole-brain atrophy and volumetric loss associated with Alzheimer’s progression.
The Phase 2 Flicker study assessed the safety and tolerability of the digital therapeutic in 10 patients with mild cognitive impairment due to Alzheimer’s. The study found that not only was the treatment safe and tolerable, but that the gamma frequency therapeutic intervention evoked the desired synchronous firing of brain cells across the brain, the company reported. That action stimulated changes in signaling molecules within the brain cells that led to changes in the cells’ immune profiles. The study also demonstrated improvements in functional connectivity between key brain regions, as shown by fMRI.
Cognito has also been on a hiring spree, just this month adding chief commercial officer Everett Crosland, who most recently served in the same role at Applied VR, and 30-year finance veteran Jonathan Lieber as CFO.
Dr. Allan Levey, professor and chairman of the Department of Neurology at Emory University and Director of the Emory Goizueta Alzheimer’s Disease Research Center, said in a news release that he is encouraged by Cognito’s approach. “This strategy translating recent advances in non-invasive modulation of brain activity with sensory stimulation with light and sound has the potential to be an urgently needed safe, non-invasive and effective treatment for millions of individuals with Alzheimer’s disease.”
Cognito declined to release its funding, but a spokesperson said its lead investor is Morningside Ventures.