FOCUSED ON DEVELOPING AN INNOVATIVE TREATMENT FOR COGNITIVE IMPAIRMENT due to raised cortisol ASSOCIATED WITH NEUROLOGICAL DISEASES

Quarterly Activity Report & Appendix 4C
Actinogen Medical released quarterly activity report and Appendix 4C for the three-month period ended 30 June 2021
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First Patient Enrolled in XanaMIA TRIAL
We are pleased to announce that the first patient has been enrolled in Part A of its two-part XanaMIA trial, which targets patients with Mild Cognitive Impairment due to Alzheimer’s Disease. "This trial will add to the considerable safety and efficacy dataset the Company has accumulated on Xanamem® and will explore the minimally effective dose to be studied in future trials" said Dr Steven Gourlay
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Actinogen receives positive Pre-IND FDA advice for FXS
Actinogen received written supportive US FDA advice in response to its Pre-Investigational New Drug Application (Pre-IND) submission for its FXS program. “The FDA’s positive Pre-IND advice for FXS marks a significant milestone in the clinical development of our second disease program. It provides greater confidence that we will obtain support from the FDA for the investigation of Xanamem in this disease that has a high unmet medical need for effective therapies." said Dr Steven Gourlay
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About Us

Actinogen Medical  (ACW) is an ASX-listed, biotechnology company developing an innovative treatment for cognitive impairment associated with neurological diseases amenable to modifications of raised cortisol levels inside brain cells. ‘Cognition’ relates to how a person understands and acts in the world around them. Cognitive functions include memory, reasoning, awareness and decision-making, and to a large extent, influence our personality.

Actinogen Medical’s lead drug candidate, Xanamem®has been specifically designed to block the production of cortisol – the stress hormone – in the brain. Chronically elevated cortisol is associated with cognitive decline in Alzheimer’s Disease, potentially linked to cognitive impairment and anxiety in Fragile X syndrome, and cognitive impairment in other diseases. 

Xanamem offers a promising new approach to treat cognitive impairment associated with these neurological diseases.

In the Company’s recent XanaHES Phase I trial, Xanamem exhibited a statistically significant improvement in cognition among healthy older volunteers treated with 20mg Xanamem daily, and recent human target engagement data for the drug in the brain suggests good activity of doses as low as 5mg daily. The Company plans to initiate a range of Phase II studies evaluating Xanamem in the treatment of cognitive impairment associated with Alzheimer’s disease, Fragile X syndrome, and other indication(s) with a strong scientific rationale.