Actinogen receives positive Interim Analysis recommendation from its independent Data Monitoring Committee to continue the XanaMIA pivotal Alzheimer's disease trial
MWN-AI** Summary
Actinogen Medical Limited (ASX: ACW) announced that its XanaMIA pivotal trial for Alzheimer's disease (AD) has received a positive recommendation from the independent Data Monitoring Committee (DMC) to continue after an interim analysis. This recommendation indicates that the safety and efficacy data reviewed—derived from approximately 37% of the projected dataset—supports the trial's continuation toward its completion in November 2026.
The interim analysis evaluated data from 136 participants, with 52 having completed 36 weeks of treatment. Throughout this process, the trial staff remained blinded to participant treatment assignments, ensuring the integrity of the data. The trial participants will continue receiving either Xanamem® 10 mg or a placebo for the full duration of 36 weeks, with the last participant's final evaluation set for September.
Actinogen is also preparing for an open-label extension phase, allowing all XanaMIA participants to access an extended period of active Xanamem therapy for up to 25 months. Key efficacy measures will be evaluated during this period, including cognitive functions and activities of daily living.
The company's CEO, Dr. Steven Gourlay, heralded the DMC's recommendation as a significant milestone, expressing optimism about the data to be reported in November. The results may position Xanamem as a game-changing oral therapy for slowing Alzheimer's progression. Meanwhile, a follow-up global pivotal trial is scheduled to commence in 2027, further solidifying Actinogen's commitment to advancing AD treatment.
With the financial backing from recent placements, Actinogen is on a secure path toward achieving its objectives, anticipating continued developments in both AD and major depressive disorder trials throughout 2026.
MWN-AI** Analysis
Actinogen Medical Limited (ASX: ACW) has received a promising recommendation from its independent Data Monitoring Committee (DMC) to continue its pivotal XanaMIA Alzheimer’s disease trial. This interim analysis results add a significant layer of credibility to Actinogen's efforts, enhancing investor confidence as the exclusivity of Xanamem® becomes apparent in the fast-evolving Alzheimer’s treatment landscape.
The DMC's approval, based on a thorough review of safety and efficacy data across 136 participants, suggests that Xanamem could potentially emerge as an innovative oral therapy – a differentiating factor in a market dominated by intravenous administrations and limited effectiveness in slowing disease progression. Investors should prudently assess whether these findings bolster Xanamem's positioning as a leading treatment for Alzheimer’s.
The continuation of the trial, culminating in topline results expected in November 2026, should be a pivotal milestone for the company. Should the results demonstrate robust efficacy, a strategic entry into larger markets through a second pivotal trial may follow in 2027, increasing Actinogen's market footprint. The data gathered from the ongoing open-label extension phase will further substantiate Xanamem's safety and efficacy profile while expanding patient access.
Financially, Actinogen’s robust funding already secures operations beyond the XanaMIA results announcement, suggesting management's confidence in achieving positive outcomes and facilitating broader investment opportunities. However, prospective investors should remain vigilant regarding inherent clinical and regulatory risks involved in biopharmaceutical developments.
In summary, with the DMC’s endorsement, ongoing data collection, and a clear path towards market approval, Actinogen Medical presents a compelling investment narrative. Nevertheless, due diligence is essential, keeping in mind the uncertainties associated with clinical trials and their outcomes.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SYDNEY, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) announces that the XanaMIA pivotal Alzheimer’s disease (AD) trial’s independent Data Monitoring Committee (DMC) has recommended that the trial continue without amendment after its interim analysis. In doing so, the DMC determined that the unblinded safety and efficacy data it reviewed support continuing the trial to its expected completion in November this year.
Highlights:
- In a confidential process designed to preserve the statistical power of the trial, the external DMC considered unblinded safety and efficacy data from approximately 37% of the expected final dataset, including 136 participants with one or more efficacy datapoints and 52 participants who had finished the full 36 weeks of treatment. All ACW staff and XanaMIA trial personnel remain blinded to participant treatment assignment
- Following the positive DMC recommendation, the XanaMIA trial will continue to treat ongoing participants with either Xanamem® 10 mg or placebo for a total of 36 weeks – enrolment of the final 247th participant occurred in December last year and the last participant’s final evaluation visit is expected in September this year
- Topline final results are due in November of this year, with subsequent presentation at a key Alzheimer’s disease scientific meeting and publication in a peer-reviewed journal
- All XanaMIA participants are potentially eligible to participate in the open-label extension (OLE) phase of the trial and will receive active Xanamem 10 mg
- A second and final global pivotal trial, similar to XanaMIA but larger, will commence in 2027 along with open-label and clinical pharmacology trials. This relatively streamlined path to approval in the US, including the design of the new trials, was agreed with the FDA in a Type C meeting last year.
Actinogen CEO and MD, Dr Steven Gourlay said:
“The positive recommendation from our independent Data Monitoring Committee is an important milestone in the successful conduct of our XanaMIA pivotal trial in patients with Alzheimer’s disease. We look forward to November when we can report final results for the full dataset of 247 participants. We anticipate that many XanaMIA participants will take up the opportunity for a longer period of active Xanamem therapy in the new open-label extension phase of the trial which will run for approximately two years.”
Dr Dana Hilt, CMO, commented:
“We are highly confident in the expert review conducted by the Data Monitoring Committee which was chaired by Dr Hans Moebius, who is a highly experienced Alzheimer’s leader and trials expert. Xanamem has the potential to be a game-changer for Alzheimer’s patients as a safe and effective oral therapy to slow or halt disease progression.”
An exciting year ahead
The 2026-year heralds further key late-stage milestones for Actinogen in its Xanamem development program.
In addition to this announcement regarding the positive outcome of the interim analysis for the XanaMIA trial, the company expects to announce the publication of the results of its XanaCIDD phase 2a major depressive disorder trial in a peer-reviewed journal during the coming months.
Preparations continue for an open-label extension trial to allow all participants in the XanaMIA trial to access longer-term active Xanamem therapy. All participants in the OLE will receive active Xanamem 10 mg once daily for up to 25 months’ treatment. The OLE will provide longer term safety data for at least 14 months for all participants and measure key efficacy endpoints such as the CDR-SB, cognition and activities of daily living.
The Company expects to receive scientific advice from the European Medicines Agency on its Xanamem Alzheimer’s development program in the second quarter and to attend and present at several industry and partnering conferences throughout the year.
Topline final safety and efficacy results for the full 36 weeks of treatment from all participants in the XanaMIA AD trial will be available in November 2026. Positive XanaMIA results will position Xanamem as a unique and differentiated oral therapy – the first to convincingly slow and potentially stabilize Alzheimer’s disease progression.
The company announced today that it is fully funded beyond the XanaMIA results in November by way of a strongly supported placement to existing and new institutional shareholders, and a share purchase plan which provides all Actinogen shareholders the opportunity to participate.
® Xanamem is a registered trademark of Actinogen Medical Limited
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 approximately 500 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 247 participants with mild to moderate Alzheimer’s disease (AD), treated for 36 weeks, followed by an open-label extension phase. The trial is now closed for recruitment and will report topline final results in November this year.
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, 11?-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 11?-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 animation, 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.
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.
Dr. Steven GourlayCEO & Managing DirectorE. steven.gourlay@actinogen.com.auInvestorsMichael RobertsInvestor RelationsE. michael.roberts@actinogen.com.auMediaGeorge HazimMedia & Public Affairs AustraliaE: georgehazim@mediaaffairs.com.au
FAQ**
Can you provide insights on how the independent Data Monitoring Committee's positive recommendation for Actinogen Medical Limited ATGGF affects the overall perception of Xanamem's potential in the Alzheimer's disease market?
What specific safety and efficacy data were reviewed by the Data Monitoring Committee for Actinogen Medical Limited ATGGF's XanaMIA trial, and how might this influence investor confidence moving forward?
Given the anticipated topline results in November 2026 for Actinogen Medical Limited ATGGF, what are the key milestones that investors should watch for that could impact stock performance?
How does Actinogen Medical Limited ATGGF plan to leverage the promising results from the XanaMIA trial in its second pivotal trial, slated to commence in 2027, to attract further investment?
**MWN-AI FAQ is based on asking OpenAI questions about Actinogen Medical Limited (OTC: ATGGF).
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