Actinogen Medical's Breakthrough Publication on Xanamem
Actinogen Medical Limited (ASX: ACW) recently announced the publication of a significant peer-reviewed article entitled Clinical Pharmacology and Approach to Dose Selection of Emestedastat, a Novel Tissue Cortisol Synthesis Inhibitor for the Treatment of Central Nervous System Disease. This article, featured in the Clinical Pharmacology in Drug Development journal, highlights the promising findings regarding the daily oral dose of 10 mg of Xanamem, which is currently under investigation in late-stage clinical trials for treating Alzheimer's disease and major depressive disorder.
The Importance of Dose Selection
The review underscores the relevance of establishing the correct dosage for Xanamem, confirming that the ongoing clinical trials utilize a 10 mg daily dose. Early pharmacokinetic (PK) modeling suggested that a higher dosage of 20 mg could be more effective. However, subsequent positron emission tomography (PET) scans indicated that lower doses of 10 mg, or even 5 mg, could sufficiently inhibit the 11?-HSD1 enzyme, validating the current testing regime.
Clinical Findings on Cognitive Benefits
Participants in clinical studies with daily doses ranging from 5 mg to 20 mg have shown an overall cognitive improvement, particularly in attention and working memory, even without a direct dose-response correlation. This consistency reaffirms that for optimal therapeutic activity of Xanamem, the daily dosage should not exceed 10 mg.
Insights from Dr. Dana Hilt
Dr. Dana Hilt, Actinogen's Chief Medical Officer, expressed confidence in the dosage determined through rigorous clinical testing. She emphasized the critical nature of thorough pharmacological assessments in determining brain effects, assuring that the findings from the XanaCIDD phase 2a trial, which demonstrated positive impact on depressive symptoms at the 10 mg dosage, align with their expectations for the ongoing XanaMIA phase 2b/3 trial for Alzheimer's.
The Role of Cortisol in Brain Health
Actinogen Medical is focused on developing innovative treatments for neurological conditions linked to cortisol dysregulation. Elevated cortisol levels are implicated in cognitive decline and can adversely affect the brain's health. Actinogen's primary drug candidate, Xanamem, is designed to mitigate these effects by inhibiting cortisol synthesis specifically within the brain while preserving adrenal function, representing a novel approach in treating Alzheimer's and related disorders.
Clinical Trials Underway
The XanaMIA Phase 2b/3 clinical trial is structured as a double-blind, placebo-controlled examination involving 220 participants with mild to moderate Alzheimer's disease. These patients are administered Xanamem at a 10 mg daily dose or placebo while the study assesses its effectiveness at slowing disease progression. The primary endpoint utilized is the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB), a respected measure in dementia studies. The trials are being conducted across multiple sites, with initial results expected from the first 100 participants soon.
Previous Successful Trials
The earlier XanaCIDD Phase 2a trial focused on individuals suffering from treatment-resistant depression. Results revealed notable improvements in depression symptoms following administration of the 10 mg dosage over a six-week period, building a solid foundation for the effectiveness of Xanamem.
About Actinogen Medical
Actinogen Medical, listed on the ASX under the ticker ACW, is a biotechnology company committed to addressing significant unmet medical needs with its innovative therapies. They are dedicated to developing treatments targeting the underlying causes of cognitive impairment and depression associated with prolonged cortisol exposure, combining scientific rigor with compassion to improve patient outcomes.
Frequently Asked Questions
What is Xanamem?
Xanamem, also known as emestedastat, is a novel therapy under investigation for its potential to treat conditions like Alzheimer's disease and major depressive disorder by inhibiting cortisol synthesis in the brain.
What were the findings from the recent publication on Xanamem?
The peer-reviewed publication confirms the effectiveness of a 10 mg daily dose of Xanamem in managing cognitive functions and emphasizes the importance of accurately determining dosage through rigorous clinical testing.
Who is leading the research behind Xanamem?
Actinogen Medical, principally led by Chief Medical Officer Dr. Dana Hilt, spearheads the research and development efforts surrounding Xanamem.
What is the current status of clinical trials for Xanamem?
Ongoing clinical trials, including the XanaMIA Phase 2b/3 trial, are assessing the safety and efficacy of Xanamem in patients with Alzheimer's disease, with results expected in upcoming years.
Is Xanamem approved for general use?
No, Xanamem is currently an investigational product and is not yet approved for use outside of clinical trials by regulatory authorities.
