#Australia #Sydney #Actinogen Medical #Xanamem #Emestedastat

Actinogen Medical Announces New Name for Xanamem: Emestedastat

In an exciting development for the pharmaceutical sector, Actinogen Medical Limited (ASX: ACW) has announced that the World Health Organization (WHO) has officially granted the nonproprietary name 'emestedastat' to its Alzheimer's treatment, Xanamem. This designation is part of the WHO's procedure for assigning generic names to pharmaceutical substances, contributing to clearer and more uniform communication within the medical community.

Understanding Nonproprietary Names

A nonproprietary name, often referred to as a generic name, is a globally recognized designation for a pharmaceutical drug. It is crucial for distinguishing active ingredients in medicines and ensuring safe prescribing and dispensing practices. Each drug marketed for therapeutic use receives such a name to prevent confusion and promote patient safety. The recent award of this name represents a landmark moment for Actinogen, showcasing its commitment to the development of innovative therapies for neurodegenerative diseases.

Significance of Emestedastat

The new name, emestedastat, features a distinctive suffix, '-stedastat,' which indicates a novel class of medications that act as 11β-HSD1 enzyme inhibitors. Xanamem operates by precisely targeting and inhibiting this enzyme in the brain, thereby regulating cortisol levels—the hormone often associated with stress. By successfully blocking the 11β-HSD1 enzyme, Xanamem distinguishes itself as a unique oral medication that specializes in controlling cortisol synthesis within brain tissues.

Actinogen's CEO, Dr. Steven Gourlay, expressed pride in this recognition. He emphasized how this designation highlights the company's leading role in the field of 11β-HSD1 inhibition, underscoring its potential benefits for patients suffering from Alzheimer's disease (AD) and major depressive disorder (MDD). The award undoubtedly paves the way for the upcoming stages of clinical trials and potential regulatory approvals.

Progress in Clinical Trials

Actinogen is currently advancing its clinical trials with the XanaMIA phase 2b/3 study. This trial focuses on patients with biomarker-positive mild to moderate Alzheimer's disease and has recently experienced growth, with over 20 sites actively screening participants across the United States and Australia. As of now, more than 300 individuals have been screened for eligibility, with 40 participants commencing the 36-week treatment phase.

The XanaMIA trial aims to enroll 220 subjects, specifically targeting those with elevated pTau181 levels in their blood—an essential biomarker for identifying progressive Alzheimer's disease. This approach enhances the potential for detecting effective treatment outcomes of emestedastat in comparison to placebo.

The primary objective of the XanaMIA study is to evaluate the clinical efficacy using the internationally recognized Clinical Dementia Rating – Sum of Boxes (CDR-SB) scale. Through this measurement, the study seeks to quantify the cognitive and functional improvements that patients experience while receiving treatment.

Commercialization Preparation

As Actinogen looks to commercialize emestedastat, the company is proactively engaging in several initiatives. Last October, Andrew Udell was appointed as Chief Commercial Officer to lead these efforts from the U.S. Moreover, discussions regarding co-development partnerships and necessary regulatory compliance with the FDA are already in motion.

Actinogen also continues to bolster its patent portfolio, ensuring commercial protection for the novel compound potentially extending well into the 2040s while preparing for various manufacturing and clinical study requirements.

The Future of Emestedastat

Actinogen is firmly positioned to pioneer new pathways in treating Alzheimer’s and major depressive disorder through emestedastat. The recognition by WHO signals a promising future not only for Actinogen but also for countless patients seeking relief from these debilitating conditions. As clinical trials progress and commercialization approaches, all eyes will be on Actinogen Medical as it aims to translate scientific advancements into life-changing therapies for those in need.

For patients or family members interested in participating in the XanaMIA clinical trial, more information is available on Actinogen's official website, where eligibility and further participation details are provided.

Actinogen Medical is redefining the potential of pharmaceutical interventions in the brain's regulation, striving to create impactful therapies that address a critical unmet medical need.