Actinogen Medical Ltd (ASX:ACW) is making progress in its Phase II clinical trial of its promising new Alzheimer’s drug Xanamem after discussions with the U.S. FDA.
The company is seeking FDA approval under an Investigational New Drug (IND) for the Phase II study of the drug.
The company is interacting with the U.S. FDA to enhance the safety profile of XanADu, their pivotal global Phase II clinical trial investigating Xanamem.
An enhanced protocol will be detemined with both Australian and U.K. regulators and hospital sites, with patients expected to be enrolled in the second half of 2016.
Importantly, a U.S. focused study and protocol design will allow for broader value creation, as the U.S. is the largest market for Alzheimer’s drugs.
Xanamem has been specifically designed to inhibit the excess production of cortisol, the ‘stress hormone’ in the brain.
Recent global research has demonstrated that excess cortisol is associated with cognitive decline and neurotoxicity in the brain, which are the hallmarks of Alzheimer’s disease.
In 2015 the total estimated global cost of treating Alzheimer’s was close to US$1 trillion.
The potential upside for a successful drug is significant, which has helped Actinogen share price almost double during the last six months.
The phase II study is fully funded through to completion with $6.8 million cash as on 31 March 2016.
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