Actinogen Medical Limited, through a Type C meeting with the FDA, has reached a common understanding with the agency on the manufacturing, clinical and nonclinical activities required for a future marketing approval of the company’s once-a-day pill, Xanamem, for Alzheimer’s disease.
Specifically, Actinogen and the FDA reached 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.
The agency agreed with Actinogen’s 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 U.S.
The current pivotal phase 2/3 trial, XanaMIA, is on track for interim analysis in January 2026 and final results late 2026 with trial enrolment expected to close in Q4 2025.
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. 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.