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Actinogen Medical (ASX:ACW) has this week enrolled its 100th participant for its “pivotal” XanaMIA phase 2b/three trial for Xanamem, its investigational drug designed to treat the cognitive decline in Alzheimer’s disease.
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The company hit its XanaMIA enrollment targets on the same day it banked the first $3 million tranche from Endpoints Capital; $10.8M more is on the way.
That cash will be funnelled straight into the XanaMIA testing starting across 35 dedicated sites, all of which are based across Australia and the U.S.
It’s a very good start to Week 27 for Actinogen, which will open at 2.2cps this morning after gaining around +15.7% in value through FY24-25’s last full week.
Perhaps more importantly, though, Actinogen’s chief executive, Dr Steven Gourley, says these two major milestones put the neurotherapeutics developer right on time for the Data Monitoring Committee’s safety review.
“We’re delighted to confirm the timeline… this confidential review of unblinded data will ensure the XanaMIA trial is on track and that Xanamem continues to perform as a promising, well-tolerated, once-a-day therapy,” Dr Gourley said.
As for the timeline beyond the Data Monitoring Committee’s independent review, Actinogen has drafted the following playbook:
- H2 2025 – FDA meeting to review program for U.S. regulatory approval
- Q4 2025 (or January 2026) – Full enrolment for 220 XanaMIA phase 2b/3 trials
- January 2026 – Independent DMC review of safety, efficacy data for XanaMIA
- Q1 2026 – Open-label extension trial enrols first patient
- Q4 2026 – Final XanaMIA results announced
A second “pivotal” trial, flagged by ACW as the third full phase, would then start in 2027.
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“The availability of a follow-on, open-label trial… should give participants and their families more incentive to participate in the XanaMIA trials as well as provide valuable long-term safety and efficacy data,” Dr Gourley added.
Regarding the $13.8M in secured cash injection, Actinogen’s CFO, Will Souter, said it was “an endorsement of the robustness of our program.”
ACW, at 2.2cps heading into Monday, hasn’t moved in futures yet.
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