Actinogen achieves agreement with the FDA in a Type C meeting on the manufacturing, clinical and nonclinical activities required for a future US marketing approval of Xanamem for Alzheimer’s disease

Current XanaMIA pivotal phase 2/3 trial on track for interim analysis in January 2026 and final results late 2026 with trial enrolment expected to close in Q4 2025

SYDNEY, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) announces the successful conduct of its scheduled Type C meeting (written response) on Alzheimer’s disease (AD) with the US Food & Drug Administration (FDA).

Actinogen and the FDA reached a common understanding of the pathway to marketing approval in AD - meaning agreement on regulatory starting materials in drug substance synthesis, the design of one additional pivotal clinical trial and the limited number of ancillary clinical pharmacology trials and nonclinical studies required. Key understandings include the:

1. ‘Regulatory starting materials‘ for the commercial manufacturing of Xanamem^® (emestedastat) drug substance
2. General design of the interim analysis for XanaMIA
3. Design of one additional, well-controlled, pivotal (phase 3) trial to support a positive XanaMIA pivotal trial
4. Single emestedastat dose design (10 mg vs placebo) for the planned pivotal Phase 3 trial
5. Number of people to be treated with Xanamem to be described in the New Drug Application (NDA) – that is, the makeup of the planned safety database consistent with FDA guidelines
6. Small number of ancillary clinical pharmacology trials to be conducted
7. Nonclinical studies required to further characterize the metabolism and excretion pathways of Xanamem.
   

The outcome reached at this meeting with the FDA’s Neurology-I Division represents a major milestone for Actinogen as the Company prepares for the earliest possible NDA submission in the US and submissions to other global regulators. It provides important clarity for ongoing discussions with potential development and marketing partners.

A similar meeting for Alzheimer’s disease (AD) will be held with European Medicines Agency in 2026 and subsequently with the UK MHRA¹ and other regulators. Actinogen’s FDA agreement is consistent with the desire of regulators worldwide to find safer and more effective therapies for AD, given the limited effectiveness of currently available treatments.

The Company can now confidently move forward following agreement from the FDA on the planned program.

Dr Steven Gourlay, the Company’s CEO and MD, commented:

“We are pleased with the clear guidance from the FDA that confirms our plans for streamlined development of Xanamem in Alzheimer’s disease. Importantly, the Agency agreed with our approach for only one additional, pivotal trial using a single 10 mg Xanamem dose design vs. placebo to support a marketing application for Alzheimer’s in the US.”

^® Xanamem is a registered trademark of Actinogen Medical Limited
¹ The UK MHRA is the United Kingdom Medicines and Healthcare products Regulatory Agency

	Investors	Media
Dr. Steven Gourlay	Michael Roberts	George Hazim
CEO & Managing Director	Investor Relations	Media & Public Affairs Australia
E. steven.gourlay@actinogen.com.au	E. michael.roberts@actinogen.com.au	E: georgehazim@mediaaffairs.com.au

About Actinogen Medical

Actinogen Medical (ACW) is an ASX-listed, biotechnology company in the late clinical stages of development for Xanamem® (emestedastat), its novel oral therapy for Alzheimer’s disease and depression. The Company is based in Sydney, Australia with operations and clinical trials in Australia and the US. Xanamem, has been studied in eight clinical trials with more than 400 people treated to date and has a promising safety and efficacy profile. ACW’s ongoing clinical trial, XanaMIA, is a phase 2b/3 trial of 220 participants with mild to moderate Alzheimer’s disease (AD) and is currently enrolling in Australia and the US. To find out more about the trial click here.

About Xanamem (emestedastat)

Xanamem’s novel mechanism of action is to control the level of cortisol in the important areas of the brain through the inhibition of the cortisol synthesis enzyme, 11β-HSD1, without blocking normal production of cortisol by the adrenal glands. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels of brain cortisol control in regions where 11β-HSD1 is highly expressed such as the hippocampus. Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be toxic to brain cells. Elevated cortisol is also associated with depressive symptoms. Xanamem has demonstrated excellent brain target engagement and in human trials has shown potential to slow progression of Alzheimer’s disease and improve depressive symptoms in patients with moderately severe depression. To view Xanamem’s two-minute Mechanism of Action video, click here.

Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority. Xanamem® is a trademark of Actinogen Medical.

List of XanaMIA phase 2b/3 trial clinical sites in the US

California Carlsbad, 92011 Orange, 92866 Sherman Oaks, 91403	New Jersey Toms River, 08755	Rhode Island East Providence, 02914
Colorado Denver, 80218 Englewood, 80113	New York Albany,12208 Staten Island, 10314	Texas Austin, 78757
Florida Delray Beach, 33445 Miami, 33176 New Port Richey, 34652 Orlando, 32803 The Villages, 32162	Ohio Dayton, 45459 Independence, 44131	Washington Bellevue, 98007
Georgia Decatur, 30030	Oregon Portland, 97225

To check eligibility: https://app.clinials.io/en-US/alzheimers

Disclaimer

This announcement and attachments may contain certain "forward-looking statements" that are not historical facts; are based on subjective estimates, assumptions and qualifications; and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements should be considered “at-risk statements” - not to be relied upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business, economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes and uncertainties) that may lead to actual results being materially different from any forward looking statement or the performance expressed or implied by such forward looking statements. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of achievement or reasonableness of any forward-looking statements and there can be no assurance or guarantee that any forward-looking statements will be realized.

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