• Late-stage trial in Alzheimer's opens 10 sites in US, with results due in 2025 and 2026
• Appoints US-based Chief Commercial Officer, Andrew Udell
• Xanamem's unique ability to control brain cortisol draws widespread coverage in the Australian media.

 Actinogen Medical Limited (ASX: ACW) announces that the first participant was randomized and treated Friday in the United States in the XanaMIA phase 2b/3 clinical trial in patients with biomarker-positive mild to moderate Alzheimer's disease (AD).

The trial is designed to select 220 participants with a progressive clinical profile, determined by elevated levels of the blood biomarker pTau181. It measures the effects of a Xanamem^® 10 mg daily dose versus placebo over a 36-week treatment period on multiple clinical endpoints of function and cognition.

With the opening of 10 new clinical sites in the US in addition to the existing 15 Australian sites, screening activities and patient enrolment is expected to accelerate to deliver interim results next year and final results in 2026.

The primary endpoint for the XanaMIA AD trial is the Clinical Dementia Rating – Sum of Boxes scale (CDR-SB), a validated combined cognitive and functional measure, recognized by the FDA and used by many companies as an endpoint for regulatory approval. Previously, in an analysis of biomarker-positive patients with mild AD treated with Xanamem, a clinically significant mean benefit vs. placebo of 0.6 points was seen on the CDR-SB endpoint after 12 weeks treatment.

A variety of secondary endpoints will be used for the trial including the Amsterdam Activity of Daily Living scale, which measures the ability to perform everyday tasks and a cognitive test battery comprising seven different digital assessments common to the field.

An interim analysis is planned for Q3 2025 when approximately 100 patients reach 24 weeks of treatment, with final results anticipated in H2 2026.

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

"We are pleased to announce the first participant treated in the US in our phase 2b/3 trial in patients with Alzheimer's disease. The ten new sites in the US will bolster the already active recruitment from our Australian sites.

"Based on the encouraging safety and clinical activity seen in multiple prior trials of Xanamem in both AD and major depressive disorder (MDD), we are confident that the trial will confirm clinically and statistically meaningful results."

Chief Commercial Officer appointed

Actinogen recently announced the appointment of US-based Mr Andrew (Andy) Udell as Chief Commercial Officer reporting to CEO Dr Steven Gourlay.

Andy Udell is a commercial leader with demonstrated success taking biotech companies from the clinic through market planning, commercial readiness and full commercial integration and will be a valuable resource for the Company as it continues commercial planning appropriate to late-stage clinical development in Alzheimer's disease and depression.

"We are delighted to announce the appointment of US-based Mr Andrew (Andy) Udell as the Company's inaugural Chief Commercial Officer. We welcome his extensive commercial experience especially in bringing CNS drugs to market as our clinical trial programs advance towards marketing approvals," said Dr Gourlay.

Most recently Mr Udell was President, North America at Calliditas Therapeutics, taking this Swedish biotech through phase 3 trials, market preparation and a successful US product launch. Mr Udell was previously the Vice President Commercial for North America for Neuroderm prior to its acquisition by Mitsubishi Tanabe Pharma. Mr Udell has significant experience working in depression, Parkinson's Disease, and other large central nervous system (CNS) markets.

Mr Udell has a Bachelor of Science degree from Lehigh University and received a Master of Business Administration from the University of Connecticut.