[March 11, 2024]

Cognito Therapeutics Announces Spectris™ OVERTURE OLE Study Data Supports Potential Disease Modification and Early Treatment in Alzheimer's Disease

Cognito Therapeutics, a leader in technology-based therapeutic interventions for neurodegenerative diseases, announced today results from the OVERTURE open label extension (OLE) study presented in an oral session at the AD/PD™ 2024 International Conference on Alzheimer's and Parkinson's Disease. The results support for Spectris'™ potential as a disease modifying therapy that, if approved, could also be used as an early intervention for the treatment of Alzheimer's Disease (AD).

"We were thrilled to be at AD/PD 2024 to present the results of our open label study that showcased extended treatment in OVERTURE participants and evaluated the potential therapeutic impact of Spectris™ over an 18-month period. These results provide support for the potential safety of prolonged treatment and highlight the potential for Spectris as a potential disease modifying therapy to preserve both brain structure and function in patients with AD," said Brent Vaughan, CEO of Cognito Therapeutics.

The OVERTURE (NCT03556280) clinical trial evaluated the safety and efficacy of Spectris™ therapy in participants with mild to moderate AD in a six-month randomized, double-blind, sham-controlled trial. 83% of the OVERTURE study patients (44/53) entered a separate 12-month open label extension (OLE) study, which allowed for further evaluation of Spectris' potential as a disease modifying therapy.

Study Results

No occurrence of amyloid-related imaging abnormalities (ARIA) or serious treatment-related adverse events was observed during the OLE study. High evice-level adherence continued throughout the OLE, with 45 minutes or more device use on 80% of treatment days.

Participants completing the initial six-month randomized trial were eligible to enter a separate 12-month OLE daily treatment study. Analysis of the 'as-treated' population revealed consistent safety, tolerability, adherence, and efficacy outcomes, including outcome measures such as ADCS-ADL and MRI to evaluate both brain structure and function. Employing a delayed start study design, the analysis also evaluated the potential of Spectris™ as a disease modifying therapy.

Participants who continued Spectris™ treatment throughout 18-months showed the potential for safety and durability of treatment effect. Those who switched from sham to Spectris™ treatment demonstrated a similar rate of decline in ADCS-ADL and whole brain volume (WBV) compared to those receiving continued active treatment from the onset. The initial separation at the end of the randomized trial, separation at the end of the OLE, and non-convergence of slopes through the OLE are consistent with accepted criteria for disease modification.

"Participants who transitioned from sham to active device treatment demonstrated similar rates of slowing of loss of function and loss of brain structure as seen in the early treatment group from the OVERTURE randomized trial, without catching up to the early treatment group," said Ralph Kern, M.D., MHSc, Chief Medical Officer of Cognito Therapeutics. "These results are consistent with accepted criteria for disease modification and support potential for use as early treatment of AD. We look forward to advancing Spectris™ therapy as a potential disease modifying therapy for the treatment of AD."

Cognito Therapeutics is currently enrolling patients for its pivotal study HOPE. For more information, visit www.hopestudyforad.com.

About Cognito Therapeutics

Cognito Therapeutics is a late clinical-stage neurotechnology company dedicated to the development of transformative disease-modifying therapies for neurodegenerative diseases. Cognito's proprietary approach targets dysregulated network activity in the brain and has shown meaningful outcomes in Alzheimer's patients. Cognito's lead product, Spectris, employs a proprietary non-invasive method designed to evoke increased gamma frequency brain activity using auditory and visual neuromodulation to slow the rate of brain atrophy and loss of brain function. Cognito's mission is to develop a new class of technology-based therapeutic interventions to transform the lives of patients with neurodegenerative diseases. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com.

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