Actinogen Medical Ltd. announced receipt of agreement from the US Food and Drug Administration (FDA) to proceed with its six-month, Phase 2b, placebo-controlled clinical trial of Xanamem ® in patients with early stages of Alzheimer's Disease (AD). This agreement comes in the context of the Company recently updating its FDA Investigational New Drug (IND) dossier with new nonclinical and clinical information to support the trial protocol. The planned Phase 2b trial will enroll 330 patients with mild AD and progressive disease, using clinical criteria and confirmed by an elevated level of pTau181 protein in the blood.

Patients will be randomized to treatment over six months with 5 mg, 10 mg or placebo once a day. Key efficacy endpoints will be those that have shown Xanamem effect in prior trials: the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) and the Cogstate computerized test battery of attention and working memory. The trial will commence in the first half of 2023 with results expected in late 2024.