Actinogen is a neurotherapeutics developer realizing a revolutionary therapy so neurology patients and their families can live their best lives
In conjunction with the US FDA and other Regulatory Authorities, we strive for excellence in science and clinical data within our programs. 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 our industry peers as we 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 strong scientific rationale for Xanamem’s action, we are rapidly developing programs in multiple disease areas including adults with Alzheimer’s Disease, Major Depressive Disorder and children with Fragile X Syndrome.
Xanamem is a cutting edge therapy and world class product that reduces cortisol (the “stress hormone”) levels in the brain. Used alone, or in combination, it may be a key element for new approaches in managing neurodegenerative and other illnesses.
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. Cognitive functions include memory, reasoning, awareness and decision-making, and to a large extent, influence our personality.
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.
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 Strategic Priorities
Clinical development excellence, designed to deliver timely and high-quality confirmation of clinical efficacy and safety in each of our disease programs:
- Alzheimers Disease (AD)
- Major Depressive Disorder (MDD)
- Fragile X Syndrome (FXS)
All current trials are conducted under a US Investigational New Drug (IND) process to ensure highest standards of regulatory compliance for non-clinical studies, manufacturing and clinical development.
We continue to develop relationships with potential future development partners such as larger global pharmaceutical companies, regional companies and peer mid-cap companies.
Building on our semi-virtual business model, skilled and experienced strategic and technical specialists will be added to the team in accordance with need as the Company grows.
Clinical Development: Active forward planning for Part B of the XanaMIA trial following the Part A results release. Ancillary clinical pharmacology studies planned. Long term clinical program designs for AD, MDD, FXS and other potential indications under regular review.
Regulatory nonclinical studies: Plan and conduct essential Good Laboratory Practice (regulatory) non-clinical studies.
Manufacturing: Explore manufacturing process improvements and scale-up work. Additional Good Manufacturing Practices (GMP) production batches to be produced to support smooth transition into later stage clinical development, ensuring that to-be-marketed Xanamem drug substance and drug product are used in pivotal, registration-enabling studies.