Actinogen Medical (ASX: ACW) is a clinical-stage biopharmaceutical company pioneering a novel approach to treating neurodegenerative diseases and neuropsychiatric conditions. Their lead candidate, Xanamem, is a first-in-class oral medication that targets brain cortisol, offering a promising new avenue for tackling Alzheimer's disease (AD), major depressive disorder (MDD), and other debilitating neurological disorders.

Following the Science: Validating the Cortisol Hypothesis

Actinogen's approach is based on the emerging "cortisol hypothesis" of AD, which posits that excess cortisol in the brain contributes to cognitive decline and disease progression. Xanamem works by inhibiting the 11β-HSD1 enzyme, which plays a crucial role in converting cortisone to cortisol in the brain. By lowering brain cortisol levels, Xanamem aims to improve cognitive function and slow disease progression.

This hypothesis gained significant validation in 2022 with the results of Actinogen's Phase 2a biomarker trial. The trial showed that treating people with biomarker-positive AD with Xanamem made a big difference in a key measure of cognitive function (CDR-SB). This finding provided strong evidence for the potential of Xanamem to address the underlying pathology of AD.

Promising Pipelines: Tackling Multiple Diseases

Actinogen is currently advancing two major Phase 2 clinical trials for Xanamem:

• XanaCIDD: This trial is investigating the efficacy of Xanamem in improving cognitive function and reducing depressive symptoms in patients with MDD and cognitive impairment. Initial enrollment is progressing well, with results anticipated in the first half of 2024.
• XanaMIA: This larger Phase 2b trial will evaluate Xanamem's effectiveness in slowing cognitive decline in patients with mild to moderate AD. The trial is on track to begin enrolling patients before the end of 2023, with final results expected in the second half of 2025.

Beyond AD and MDD, Xanamem also holds potential for treating other conditions associated with elevated brain cortisol, such as Fragile X syndrome and post-traumatic stress disorder (PTSD). Actinogen is actively exploring these additional opportunities through preclinical and early clinical research.

Building a Strong Team and Engaging Stakeholders

Actinogen recognises the importance of a strong team and engaged stakeholders in its journey towards success. The company has recently bolstered its leadership with the appointments of Dr. Dana Hilt as Chief Medical Officer and Dr. Nicki Vasquez as an independent non-executive director. Additionally, Actinogen has launched the "Clinical Trials Science Forum" to educate investors and the public about the science behind Xanamem and its clinical development programme.

Investing in the Future of Brain Health

Actinogen Medical is at the forefront of developing innovative therapies for some of the most challenging neurological disorders. With a validated scientific approach, promising clinical pipelines, and a dedicated team, Actinogen is well-positioned to make a significant impact on the lives of millions of patients worldwide. As the company continues to advance its clinical programmes and explore new opportunities, investors and stakeholders alike will be watching closely with anticipation.

In conclusion, Actinogen Medical is a biopharmaceutical firm in the clinical stage that is focused on developing Xanamem, an innovative oral drug designed to specifically target brain cortisol. Xanamem exhibits potential for the treatment of Alzheimer's disease, major depressive disorder, and various other neurological diseases. The positive outcomes of the Phase 2a biomarker experiment have supported the "cortisol hypothesis" of AD. Xanamem is now being tested in two significant Phase 2 trials for major depressive disorder (MDD) and Alzheimer's disease (AD). Actinogen is now conducting extensive research on Xanamem's possible applications in various neurological conditions. The organisation is dedicated to constructing a robust team and actively involving stakeholders. Investing in Actinogen Medical offers the chance to participate in a company at the forefront of brain health research with the potential to have a significant impact on the lives of numerous individuals.