Cognito Therapeutics, a clinical-stage company developing a new class of disease-modifying digital therapeutics to treat neurodegenerative disorders, announced today that it will advance its lead product which has received FDA Breakthrough Device Designation, into pivotal studies in the second half of this year, based on results from two clinical studies announced at the Alzheimer’s Disease Parkinson’s Disease Conference (AD/PD) 2021.
Results from FLICKER, a 10-patient Phase 2 study, assessed the safety and tolerability of the digital therapeutic in patients with mild cognitive impairment due to AD. Patients in this study were assigned to one of two groups. The sham group did not receive therapy for four weeks, followed by gamma neuromodulation therapy, one-hour daily for four weeks. The treatment group received one-hour daily therapy for eight weeks. Results showed the therapy was safe, with no reported severe adverse events, with participants showing a high tolerance to the treatment. The study adherence rate was 95.5%, with 90% of patients volunteering to continue participation in an open-label extension study.
Additionally, the FLICKER study found that the gamma frequency therapeutic intervention evoked the desired entrainment - synchronous firing of brain cells across the brain - and stimulated changes in signalling molecules within the brain cells that led to changes in the cells' immune profiles. The study also demonstrated improvements in functional connectivity between key regions of the brain as shown by fMRI.
OVERTURE was a larger Phase 2 study, enrolling 76 patients with mild to moderate AD, randomized to receive either gamma frequency neuromodulation or a placebo over a six-month period. Cognitive and functional abilities, as well as brain volumetric changes, were evaluated. Over the 6-month period, patients in the treatment group exhibited a significant 84% slowing of functional decline in ADCS-ADL scores as well as a significant 83% slowing in memory and cognitive decline as measured by MMSE scores compared to sham. OVERTURE study investigators found a statistically significant benefit of the treatment of a 61% reduction in whole brain atrophy and volumetric loss associated with Alzheimer’s progression.
"The important takeaway from both FLICKER and OVERTURE is that these studies further elucidate the mechanism of action of gamma frequency neuromodulation from changes in chemokine and cytokine expression to evidence of changes in neural networking and connectivity, even in these small cohorts," said Dr. James Lah, principal investigator of the FLICKER study and director of the cognitive neurology program at Emory University. "The results are mechanistically relevant and deserves additional study."
"The evidence from these studies highlight the broader clinical impact our digital therapeutic’s unique approach has on the patient, compared to existing AD therapies that target just one aspect of the disease," said Dr. Tom Megerian, Chief Medical Officer at Cognito. "Our product doesn’t just target tau or amyloid beta, but has a unique mechanism of action that effects clearance of both of these pathologies. It is not selective for a single pathology and that is critical. We believe the complimentary activity of the increased neuro-networking and functional brain connectivity shown by the FLICKER study, is an approach that is long overdue in Alzheimer’s therapeutic interventions."
"Based on the exciting Phase 2 results from two studies announced at AD/PD, we believe this could be the first disease-modifying digital therapeutic for the treatment of Alzheimer’s disease," said Brent Vaughan, CEO, Cognito Therapeutics. "Our therapy has the potential to be used in combination with traditional AD approaches or as monotherapy. The data from the OVERTURE study will inform the design of our pivotal trial, which is expected to initiate in the second half of this year."
About Cognito Therapeutics
Cognito Therapeutics is a clinical-stage company developing a pipeline of disease-modifying digital therapeutics that have clinically demonstrated drug-like effects using gamma frequency neuromodulation to treat neurodegenerative disorders including Alzheimer’s disease. The company’s licensed proprietary gamma frequency neuromodulation platform technology, developed by scientific founders at MIT, Professors Li-Huei Tsai and Ed Boyden is a non-invasive therapy utilizing visual and auditory stimulation to treat neurodegenerative diseases. The company is based in Boston and San Francisco. For more information, please visit www.cognitotx.com. Follow us on Twitter at @cognitotx.
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