Actinogen Medical Administers First Patient in Phase 2b Alzheimer’s Disease Trial

Actinogen Medical Ltd (ASX:ACW) has treated the first patient in the randomised XanaMIA phase 2b clinical trial in patients with biomarker-positive mild to moderate Alzheimer’s disease (AD).

The trial of 220 participants with elevated levels of the blood biomarker pTau, measures the effects of a Xanamem® 10 mg daily dose versus placebo over a 36-week treatment period.

Xanamem is an oral, once a day treatment.

The primary endpoint for the AD trial is a cognitive test battery comprising seven different digital assessments.

This is de-risked by extensive existing clinical data from four previous trials of Xanamem 10mg.

The trial has commenced at thirteen Australian sites and will subsequently expand to the U.S.

Developing Xanamem

Actinogen is currently developing its lead compound, Xanamem, as a promising new therapy for AD and depression.

The company also hopes to study Fragile X Syndrome and other neurological and psychiatric diseases in the future.

How Xanamem works

Xanamem® lowers brain cortisol to treat patients with cognitive impairment associated with depression and AD.

Elevated brain cortisol is strongly associated with Alzheimer’s and depression, and the company has positive clinical efficacy data from three placebo-controlled trials.

This provides Actinogen with an opportunity across two key markets.

AD is considered a US$14 billion market with peak sales potential of US$5 billion, with the depression market US$17 billion with peak sales potential of US$2 billion.

Confidence of results

Dr Steven Gourlay, managing director, commented:

“Based on encouraging safety and clinical activity seen in multiple prior trials of Xanamem, and a strong scientific rationale for reducing brain cortisol levels, we are confident that the trial will confirm clinically and statistically meaningful results.”

The trial is designed to confirm that Xanamem is a safe and effective new treatment for AD, providing a major opportunity for patients and the company.

Gourlay added: “The clear priority for the next 18 months is to deliver high quality results from our on-going phase 2 clinical trials in depression and Alzheimer’s disease, the first of which will report results in Q3 this year.”

 

 

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