FDA feedback puts Actinogen’s phase II trial one step closer to US approval

Published at Jun 8, 2016, in Biotech

Following FDA feedback, Actinogen Medical (ASX:ACW) is progressing well towards final FDA approval of its Phase II trial of XanamemTM, 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 XanamemTM 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 XanamemTM

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.

XanamemTM 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.

S3 Consortium Pty Ltd (CAR No.433913) is a corporate authorised representative of LeMessurier Securities Pty Ltd (AFSL No. 296877). The information contained in this article is general information only. Any advice is general advice only. Neither your personal objectives, financial situation nor needs have been taken into consideration. Accordingly you should consider how appropriate the advice (if any) is to those objectives, financial situation and needs, before acting on the advice.

Conflict of Interest Notice

S3 Consortium Pty Ltd does and seeks to do business with companies featured in its articles. As a result, investors should be aware that the Firm may have a conflict of interest that could affect the objectivity of this article. Investors should consider this article as only a single factor in making any investment decision. The publishers of this article also wish to disclose that they may hold this stock in their portfolios and that any decision to purchase this stock should be done so after the purchaser has made their own inquires as to the validity of any information in this article.

Publishers Notice

The information contained in this article is current at the finalised date. The information contained in this article is based on sources reasonably considered to be reliable by S3 Consortium Pty Ltd, and available in the public domain. No “insider information” is ever sourced, disclosed or used by S3 Consortium.

Thanks for subscribing!