How long did it take all the other disease modifying Alzheimer's drugs to get to market? A big problem with the development curve was because the first phase2 results emerged about the same time as the global financial crisis.
Roche 1st phase 1 for Gantenerumab started in 2006. They are now in a phase2 with prodormals, which they changed into a phase 3 and will be completed in 2016. They pulled the trigger on this on the strength of biomarkers alone, so they have cut a lot of corners and it is still a decade, and that will be their first look at efficacy in cognition.
Prana, with an Alzheimer's cognition efficacy signal published from a previous phase2, a fast track candidate about to report ph2 results and a second ph2 Alzheimer's trial to collect a biomarker package and confirm efficacy, about to complete this year, Prana are probably not doing so bad considering the resources of both companies.
In 2005 Prana cancelled the already approved PLAQUE ph2/3 trial for PBT1 and began ph1 testing of PBT2.
In 2006 ph1s were complete and regulatory approval was recieved for the Ph2a in October that year. It commenced in December in Australia and Sweden.
In Feb 2008 Prana announced success of the 2a trial. 2008 Discovery of the Parkinson's drug.
July 2008 2a trial results published in Lancet.
The 2007-2010 financial crisis could not have come at a worse time for Prana, needing to raise investor funds for a new trial.
April 2010 New analysis of trial data, using a ranking analysis, identifies more efficacy, published in JAD and correction published in Lancet.
Now if Prana can survive the GFC and still reach market before the Roche effort, I think they will have done OK.