If at first you don't succeed, you stop the trial in phase II -- apparently. Phase II failures are on the rise with only an 18% success rate in 2008-2010 versus 28% seen in 2006-2007.
A recent report published in Nature Reviews Drug Discovery examined the fate of 108 phase II development failures between 2008 and 2010. The results showed:
- 87 of 108 reported a reason for the ceased phase II project
- 44 of 87 stopped due to inadequate efficacy
- 25 of 87 stopped due to "strategic reasons" (we shall return)
- 17 of 87 stopped due to safety concerns
- 21 reported no reason
The study concluded that "strategic reasons" was likely code for inadequate differentiation from more advanced drugs on the market. This likely occurs as too many companies are chasing too few of the same targets. Similarly, it is suspected that the 21 with "no reason" reported also represents instances of too little differentiation from more clinically advanced products as 17 of the 21 were with validated targets.
The authors also believe that recent M&A activity, subsequent "rationalization" of the pipeline and the need to "manage R&D costs" further accelerated the phase II plug pulls. Perhaps optimistically, the authors say the trend toward more research with rare diseases (novel targets) and greater emphasis on patient stratification (companion diagnostics anyone?) will help slow this phase II decline. Also, business models that emphasize external partnering and formation of consortia to lay off risk will be beneficial too.
Posted by Bruce Lehr May 11th 2011.