BioTuesdays

Cognito presents positive Spectris data at AAIC; highlights Firefly collaboration for biomarker discovery using BNA technology

Closely held Cognito Therapeutics has announced five new poster presentations at the Alzheimer’s Association International Conference (AAIC) 2025, supporting the clinical efficacy and neuroprotective mechanism of its lead investigational therapy, Spectris, in patients with Alzheimer’s disease.

According to Cognito, data derived from the OVERTURE feasibility trial and its open-label extension study demonstrated that Spectris significantly reduced the rate of functional and structural decline over six months, and cognitive, functional, and structural decline over 18 months. In addition to traditional clinical endpoints, improvements were observed in patient-centered outcomes assessed through the What Matters Most (WMM) framework. Spectris participants experienced significantly less decline in 12 of 41 WMM items, including independence in daily activities, communication, cognitive processing, emotional stability, and social engagement.

In the press release, Christian Howell, CEO of Cognito, commented, “The new findings presented at AAIC reinforce the potential of Spectris to not only slow cognitive and functional decline, but to provide meaningful structural preservation that could shift the treatment paradigm in Alzheimer’s.

Ralph Kern, M.D., MHSc, CMO of Cognito, remarked, “We’re now seeing consistent outcomes with Spectris across clinical, imaging, and patient-centered domains. These findings deepen our understanding of Spectris’ neuroprotective mechanisms and further support our path toward regulatory engagement.”

Additionally, Cognito highlighted its ongoing collaboration with Firefly Neuroscience (NASDAQ: AIFF), which is analyzing EEG data from OVERTURE using its proprietary, FDA-cleared Brain Network Analytics (BNA) platform. This partnership aims to identify neurophysiological biomarkers that may predict individual response to Spectris, monitor longitudinal changes in brain network activity, and correlate with functional cognitive outcomes such as Alzheimer’s Disease Cooperative Study—Activities of Daily Living (ADCS-ADL) and Mini-Mental State Examination (MMSE) cognitive function, as well as imaging outcomes with MRI.

In a statement to BioTuesdays, Gil Issachar, CTO of Firefly, said, “Cognito has an unprecedented dataset, with an amazing potential to treat symptoms of devastating CNS disorders, such as Alzheimer’s. Firefly has the most comprehensive datasets to help target the treatment to the areas of the brain and make it more effective. We are delighted to be partnering with Cognito for such a worthy cause, and not only look forward to working with them, but also with other device and pharma clients in the future, further growing our B-to-B business segment.”

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