Cognito Therapeutics — which is a pioneer in developing disease-modifying therapeutic interventions for neurodegenerative diseases — and Aetion, a global real-world evidence (RWE) technology and analytics provider, announced a strategic partnership to develop a validated predictive model to identify patients with rapidly progressing mild cognitive impairment (MCI) and Alzheimer’s disease.

Why does it matter?

This first-in-class predictive model would accelerate clinical development for Cognito’s late-stage clinical program in mild-to-moderate MCI and Alzheimer’s disease by identifying patients who may benefit from treatment earlier. The model, built on claims from five million commercial and Medicare lives, will enable population-level risk and cost assessments for payers and integrated health systems, clinical study population, enrichment, and, upon market availability, support deployment of Cognito’s intervention to patients who are at the highest risk of rapid disease state progression.

Aetion is a recognized global leader in transforming real-world data into RWE and in predictive analytics and health economic modeling. Aetion is championing the expansion of RWE in medical devices, diagnostics, and digital therapeutics.

Cognito will launch a multi-study late-stage clinical program evaluating its disease-modifying optogenetics-based therapeutic in patients with MCI and mild-to-moderate Alzheimer’s disease this year.

On the record

“We are proud to partner with Cognito Therapeutics, who are developing novel therapies for neurodegenerative diseases,” said Carolyn Magill, CEO of Aetion. “We are committed to addressing the unmet medical needs of patients with MCI, who are in urgent need of clinically proven, safe, and affordable therapies.”

“Aetion is a leader in turning real-world data into RWE to inform critical decision-making across product development, reimbursement, and commercialization,” said Brent Vaughan, CEO of Cognito Therapeutics. “Our partnership with Aetion to develop an innovative model will accelerate our late-stage clinical programs and bring our therapy to the millions of patients living with MCI and Alzheimer’s disease, where safer options are still needed.”

The context

There are approximately 13.5 million adults over the age of 65 living with MCI in the United States, and approximately 16% of MCI patients convert to Alzheimer’s each year. MCI represents the top contributor to Alzheimer’s prevalence, which currently costs the US healthcare system $305 billion per year.