FDA Meeting Success and Manufacturing Scale-Up Reduce Risks for Actinogen’s Xanamem
Actinogen Medical advances its XanaMIA phase 2b/3 Alzheimer’s trial with faster patient enrolment and expands clinical sites, while achieving a pivotal FDA meeting outcome for its depression program. The company maintains a strong cash position, supporting ongoing development and commercialization efforts.
- XanaMIA phase 2b/3 Alzheimer’s trial enrolment accelerates with 35 new patients passing biomarker screening
- FDA Type C meeting yields clear regulatory pathway for Xanamem’s major depressive disorder indication
- World Health Organization grants the nonproprietary name ‘emestedastat’ to Xanamem
- Manufacturing scale-up progresses with 15kg batch production advancing commercial readiness
- Company ends quarter with $18.7 million cash and runway into mid-late 2026
Accelerating Clinical Progress in Alzheimer’s Disease
Actinogen Medical (ASX: ACW) has reported significant momentum in its XanaMIA phase 2b/3 clinical trial targeting Alzheimer’s disease (AD). The trial, designed to enroll 220 participants with elevated blood biomarker pTau181 indicative of progressive AD, has seen patient screening and enrolment accelerate notably. Over 560 individuals have been pre-screened, with 60 patients already entering the 36-week treatment phase and an additional 35 passing biomarker screening, poised for imminent enrolment.
The expansion of clinical sites is a key driver of this acceleration. The company now operates 15 active recruitment sites each in Australia and the United States, with five more US sites commencing active screening, bringing the total to 35. This geographic diversification enhances recruitment capacity and trial robustness.
An interim analysis is planned for Q4 2025 once approximately 100 patients reach 24 weeks of treatment, offering an early read on Xanamem’s efficacy. Final trial results are anticipated in Q4 2026, positioning Actinogen well within the competitive Alzheimer’s therapeutic landscape.
Regulatory Milestone: FDA Meeting Advances Depression Program
In a notable regulatory development, Actinogen successfully completed a Type C meeting with the US Food & Drug Administration (FDA) concerning its major depressive disorder (MDD) program. The meeting yielded a consensus on the additional clinical and nonclinical studies required for marketing approval of Xanamem in MDD, marking a critical step forward.
This constructive engagement with the FDA’s Psychiatry Division not only clarifies the regulatory pathway but also strengthens Actinogen’s position in discussions with potential partners and funding bodies. A similar FDA meeting focused on Alzheimer’s disease is scheduled for later in 2025, expected to further define the path to approval.
Branding and Manufacturing Progress
Earlier this year, the World Health Organization granted the nonproprietary name (INN) ‘emestedastat’ to Xanamem, recognising it as the first drug in its class of 11β-HSD1 enzyme inhibitors. This naming milestone underscores the drug’s novel mechanism as a brain-penetrant tissue cortisol synthesis inhibitor, designed to mitigate toxic cortisol levels implicated in neurodegeneration and depression.
On the manufacturing front, Actinogen advanced the scale-up of drug substance production with a 15kg batch from contract manufacturer Asymchem. This scale-up is pivotal for regulatory approval of commercial manufacturing processes and signals readiness for potential market launch and partnerships.
Financial Strength and Strategic Initiatives
Financially, Actinogen closed the quarter with $18.7 million in cash, down from $22.9 million at the start of the year, reflecting $4.2 million in operating cash outflows primarily driven by research and development and staff costs. The company’s cash runway extends into mid-late 2026, providing a solid foundation to support ongoing clinical activities and strategic initiatives.
Complementing clinical progress, Actinogen is actively engaging in commercial planning, expanding its strategic team, and pursuing partnership discussions with entities interested in Alzheimer’s and depression therapies. The company is also exploring grant opportunities to supplement funding and continues to strengthen its intellectual property portfolio to protect Xanamem from generic competition.
Scientific Engagement and Upcoming Events
Actinogen’s leadership remains visible in the scientific community, with presentations at key conferences such as the ASX Small & Mid-Caps Conference and the International Conference on Alzheimer’s & Parkinson’s Diseases. Upcoming in May 2025, the company will host a Clinical Trials Science Forum webinar focusing on commercialization preparedness, featuring senior executives and expert guest speakers.
These activities reflect Actinogen’s commitment to transparency, scientific rigor, and strategic positioning as it advances toward pivotal clinical milestones and eventual market entry.
Bottom Line?
With clinical momentum and regulatory clarity building, Actinogen is poised for critical data readouts and partnership breakthroughs in the coming year.
Questions in the middle?
- Will the interim analysis in Q4 2025 demonstrate a clear clinical benefit of Xanamem in Alzheimer’s patients?
- What additional studies will the FDA require post-Type C meetings to support marketing approval for both AD and MDD indications?
- How will Actinogen’s partnering discussions evolve, and could they lead to strategic alliances or licensing deals before final trial results?
