Cambridge Cog Regulatory News (COG)

16 January 2025

Cambridge Cognition Holdings plc

("Cambridge Cognition", the "Company" or the "Group")

Actinogen Enhances Phase 2b/3 Alzheimer's Trial with Cambridge Cognition's Full Digital Suite

Cambridge Cognition Holdings plc (AIM: COG), a brain health software group specialising in digital products that advance brain health research and treatment, is pleased to announce the expansion of its partnership with Actinogen Medical Limited (ASX: ACW) for the Phase 2b/3 XanaMIA Alzheimer's disease trial. Building on the successful integration of Cambridge Cognition's full product suite including Cognitive Assessments (CANTAB), electronic Clinical Outcome Assessments (eCOA), and automated quality assurance (AQUA) during the first phase of this international study launched last year, Actinogen will continue to leverage the company's validated tools for more precise clinical measurements. This expanded collaboration underscores the proven effectiveness of Cambridge Cognition's solutions, with Actinogen opting to extend and enhance their use in this critical Alzheimer's research.

With dementia currently affecting 47 million people worldwide - a number projected to increase to 75 million by 20301 - Cambridge Cognition is proud to partner with innovative companies such as Actinogen who are making pioneering steps within Alzheimer's research by developing a novel therapy for neurological diseases designed to control elevated levels of brain cortisol and thus slow or halt disease progression.

The Phase 2b/3 trial includes 220 patients with mild or moderate dementia due to Alzheimer's disease and elevated levels of the plasma biomarker, pTau181. Patients will receive emestedastat (Xanamem2) 10 mg or placebo, once daily, and the trial is intended to show emestedastat's ability to slow progression of Alzheimer's disease by assessing a variety of endpoints over a 36-week period of treatment. The primary endpoint of the trial is the CDR-SB (Clinical Dementia Rating scale - Sum of Boxes) supported by Cambridge Cognition, alongside the secondary cognitive endpoint including Cambridge Cognition's CANTAB Attention and working memory battery as well as the automated quality assurance solution - AQUA. Ongoing use of Cambridge Cognition's full product suite within this trial ensures greater comparability and superior data quality across Actinogen's clinical development programme.

Rob Baker, Joint Managing Director and Chief Operating Officer at Cambridge Cognition, commented:

"We are proud to deepen our collaboration with Actinogen in their important work in Alzheimer's research. This partnership highlights the value of our integrated platform in advancing innovative studies. By leveraging our comprehensive suite of solutions, sponsors can optimise their clinical assessments while upholding exceptional data quality standards. Our approach ensures consistent, reliable endpoint measurements across the entire trial, ultimately strengthening the scientific validity of research outcomes."

 Dr Steven Gourlay, Actinogen's CEO and MD, commented:

"Actinogen's commitment to advancing Alzheimer's research demands robust and reliable data collection. Cambridge Cognition's integrated platform - combining CANTAB, eCOA, and AQUA - provides us with validated cognitive assessments and high-quality endpoint measurements that are crucial for evaluating the therapeutic benefits of emestedastat. This comprehensive solution strengthens our confidence in the data integrity for our XanaMIA trial."

[1] The epidemiology and impact of dementia: current state and future trends. Geneva: World Health Organization; 2015, Document WHO/MSD/MER/15.3, available at http://www.who.int/mental_health/neurology/dementia/dementia_thematicbrief_ epidemiology.pdf (accessed 8 March 2017)

2 Xanamem is a registered trademark of Actinogen Medical Limited

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About Cambridge Cognition

Cambridge Cognition is a brain health software group specializing in digital health products that advance brain health research and treatment.

The company offers four core products: CANTAB® assessments-providing scientifically validated, highly sensitive, precise, and objective measures of cognitive function correlated to neural networks; a flexible and proven eCOA platform with an extensive library of instruments, enabling efficient study setup and scalable data capture; rater training services that standardise assessment delivery and scoring across clinical trials and quality assurance tools that ensure data integrity by automatically detecting deviations in administration and scoring, saving time and money. These products collectively improve clinical trial outcomes, enable early patient identification, and enhance global efficiency in healthcare and pharmaceuticals.

For further information, visit: www.cambridgecognition.com

About Actinogen

Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol. There is a strong association between cortisol and detrimental changes in the brain, affecting cognitive function, harm to brain cells and long-term cognitive health. Cognitive function means how a person understands, remembers and thinks clearly. Cognitive functions include memory, attention, reasoning, awareness and decision-making. Actinogen is currently developing its lead compound, emestedastat (Xanamem), as a promising new therapy for Alzheimer's disease and depression and hopes to study Fragile X syndrome and other neurological and psychiatric diseases in the future. Reducing cortisol inside brain cells could have a positive impact in these and many other diseases. The cognitive dysfunction, behavioural abnormalities, and neuropsychological burden associated with these conditions is debilitating for patients, and there is a substantial unmet medical need for new and improved treatments.

For further information, visit: www.actinogen.com.au