RE: strong filling17 Sep 2020 17:44
Yes that's always a bitter read but let's brake down the numbers. Generally the Phase 2 to Phase 3 success rate, which means the chance that a drug which has entered Phase 2 will later also enter Phase 3 is just north of 30%. This tragic number however takes into account all kinds of discontinuations, so failures of safety and efficacy of course but also a lack of funding, bankruptcy, lack of interest and all other reasons why development might not be pursued.
Now for Drugs in gastroenterology the success rate is a bit higher fortunately, but perhaps most importantly the drugs you see in the list above have some individual peculiarities which shift the potential for success more into the positive. SYN-010, MD-7246 and Aemcolo are already approved and on the market which substantially lessens their safety concerns compared to an entirely new compound. Vibegron has cleared several other clinical trials and IBS is the 3rd indication. So far results have been solid and therefore approval is also more likely. Olorinab has already cleared Phase 2a trials and BOS-589 has very little systemic uptake, but this is something we should not take into account at this point.
Out of these 7x0.3=2.1 will make it into Phase 3 if we're conservative. Because so many of them have a favorable filing situation (505(B)2 has a much higher success rate) in an optimistic scenario I'd say we can allow ourselves to dream of 3 out of 7. Anything more than that would be astonishing.
Interesting read, also taken from Reddit.