Actinogen is a neurotherapeutics developer realizing a revolutionary therapy so neurology patients and their families can live their best lives
Our Fundamentals
In conjunction with the US FDA and other regulatory authorities, we strive for excellence in science and clinical data within our programs. As a result, we’ve conducted multiple high-quality clinical trials to bring our molecule, Xanamem, to this Phase 2 stage of development.
We are valued and respected by patients, physicians, and industry peers to bring Xanamem’s development forward. Science, data and transparency guide us to bring hope and potentially change the world of cognitive impairment forever.
Building on the solid scientific rationale for Xanamem’s action, we are rapidly developing programs in multiple disease areas, with a priority on Alzheimer’s Disease and Depression.
Xanamem is a cutting-edge therapy and world-class product that reduces cortisol (the “stress hormone”) levels in the brain. As a result, it is a catalyst for new approaches in managing neurodegenerative and other illnesses.
About Us
Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological diseases associated with dysregulated brain cortisol. There is a strong association between cortisol and detrimental changes in the brain, affecting cognitive function, harm to brain cells and long term cognitive health.
Cognitive function means how a person understands, remembers and thinks clearly. Important cognitive functions include episodic and working memory, attention, problem solving, and language.
We are currently developing our lead compound, Xanamem®, as a revolutionary new therapy for Alzheimer’s Disease, Major Depressive Disorder, Fragile X Syndrome, and other neurological diseases where reducing cortisol inside brain cells could have a positive impact. The cognitive dysfunction, behavioral abnormalities, and neuropsychological burden associated with these conditions is significantly debilitating for patients, and there is a substantial unmet medical need for new and improved treatments.
About Xanamem® (emestedastat)
Xanamem’s novel mechanism of action works by blocking the production of intracellular cortisol through the inhibition of the 11β-HSD1 enzyme in the brain. Xanamem is designed to get into the brain after it is absorbed in the intestines upon swallowing its capsule.
Chronically increased cortisol is associated with cognitive decline in Alzheimer’s Disease, potentially linked to cognitive impairment in Depression and cognitive impairment and anxiety in Fragile X Syndrome, and other diseases.
The Company has studied 11β-HSD1 inhibition by Xanamem in more than 300 volunteers and patients, so far finding a statistically significant improvement in cognition over placebo in healthy, older volunteers. A series of Phase 2 studies in multiple diseases is being conducted to further confirm and characterize Xanamem’s therapeutic potential.
® Xanamem is a registered trademark of Actinogen Medical Limited. Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority.
Our Team
Annual Reports
Our Strategic Priorities
development in
Alzheimer’s disease
phase 2b trial design
in depression
planning
prospective development
and commercial partners
- Enrol same patient population where the large Xanamem effect was seen in patients with AD elevated blood pTau181 protein
- Rapidly pre-screen patients for elevated pTau and key clinical criteria to minimize later costly screening failures
- Ensure high quality rating training and standardization to minimize noise in subjective endpoints like the CDR-SB
- Leverage ‘hands on’ Australian-based clinical operations and management supplemented by select use of US contractors to speed timelines and reduce cost.
- Complete full analysis of phase 2a clinical trial data to identify ideal population and endpoints for future trials
- Discuss results and proposed protocol design with major stakeholders, including local and global thought leaders in MDD, potential strategic development partners and key regulators
- Submit protocol to the FDA IND dossier and wait 30 days for clearance.
- Optimize manufacturing processes for supply of future clinical trials and marketed product
- Use to-be-marketed tablet formulation in all trials
- Leverage regulatory designations such as ILAP (granted for AD) and FDA breakthrough (planned for AD and possibly depression) where possible
- Integrate global regulatory strategic planning to optimize path to marketing approvals in multiple geographies
- Plan and conduct required regulatory nonclinical studies to the Good Laboratory Practice standard
- Plan and conduct ancillary clinical pharmacology studies required for marketing approvals.
- Consider all types of value-add partnerships in the near term once XanaCIDD results are finalized
- Proactively engage with the universe of potential biopharma partners who could bring co-development synergies to the Xanamem programs
- Maintain close working relationships with key regulators such as the US FDA, UK MHRA and the EMA
- Partner with leading clinical trial implementation providers
- Partner with key community AD and depression organizations in Australia and globally.