FDA feedback puts Actinogen’s phase II trial one step closer to US approval
Following FDA feedback, Actinogen Medical (ASX: ACW) is progressing well towards final FDA approval of its Phase II trial of Xanamem™, its Alzheimer’s disease drug.
Actinogen plans to run the trial in the US – the largest market for Alzheimer’s drugs in the world.
The ASX-listed biotech company told its investors in a note this morning that good progress had been made in securing final FDA regulatory approval under an Investigational New Drug (IND) for its Phase II trial.
After feedback from the FDA, Actinogen will develop a revised protocol around the Phase II trial which will be harmonised across the US, UK and Australian research sites.
Patients are expected to be enrolled in the Phase II trial in the second half of this year.
Actinogen told shareholders that the harmonisation of the protocol around the Phase II trial was important “in light of the changing competitive and regulatory landscape in Alzheimer’s drugs in development”.
Actinogen will also receive a significant visibility boost in the global medical research community when it presents its data on Xanamem™ at major US Alzheimer’s congresses and publishes the results in peer-reviewed medical journals, in the second half of the year.
About ACW and Xanamem™
ACW is led by Dr Bill Ketelbey, a former Pfizer Vice President who played a leading role in developing the multi-billion dollar drug Aricept in Australia and New Zealand.
Xanamem™ has been developed to specifically target the 11B-HSD1 enzyme which produces cortisol, the so-called ‘stress hormone’.
ACW is targeting cortisol as it says there is substantial evidence that excess cortisol in the body leads to changes affecting memory and the development of abnormal amyloid protein plaques and neural death, in the brain – the hallmarks of Alzheimer’s disease.
The cost of Alzheimer’s treatment in the US alone was estimated to have reached $250 billion back in 2013 – with this figure tipped to rise to $1 trillion by 2050.
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