P518 Ulcerative colitis drug development success rates are higher than the industry average
G. Georgiev1, F. Hussain1, M. Copeman2, M. Delegge1, M.B. Gallagher1, T. Stewart1, W. Reinisch3
1IQVIA, Therapeutic Science and Strategy Unit, Raleigh, USA, 2IQVIA, Project Leadership, Raleigh, USA, 3Department of Gastroenterology, University of Vienna, Vienna, Austria
Background
Given the increasing costs of drug development, coupled with low success rates, there is a need to both develop better predictive models and elucidate causes of failure. However, for indications such as ulcerative colitis, a baseline does not presently exist. In this paper, we review trends in drug development and establish a baseline for ulcerative colitis.
Methods
We used BiomedTracker to obtain information about the number of compounds, which were in development for ulcerative colitis between 2005 and 2018. We counted the number of compounds, which had reached a particular phase, had been discontinued during this phase, had successfully passed it or had been still in this phase. Success rates were derived for the different phases of drug development for all 73 candidate drugs and divided by type of molecule and type of company. A success rate was calculated by dividing the number of drugs successfully completing a particular phase by the sum of the number of drugs which were discontinued during this phase and the number of compounds that completed positively a phase. The likelihood for approval (LOA) for each phase was calculated by multiplying the success rate for the respective phase with the success rates of next stages of development.
Results
The success rate in phase I was 96 %, in phase II 53 % and in phase III 76%, while the respective LOA was 0.39, 0.4 and 0.76. Table 1 demonstrates the success rates and LOA by type of compound(New molecular entity (NME), Biologic, non-NME) and type of company (big, mid-size, emerging).
| Total | Big companies | Mid-size companies | Emerging | Biologics | NMEs | non-NMEs | |
| Success rate phase I | 96% | 94% | 100% | 100% | 100% | 86% | NA |
| Success rate phase II | 53% | 55% | 42% | 50% | 48% | 38% | NA |
| Success rate phase III | 76% | 88% | 25% | NA | 71% | 83% | 77% |
| LOA from phase I | 0.39 | 0.45 | 0.11 | NA | 0.34 | 0.27 | NA |
| LOA from phase II | 0.4 | 0.48 | 0.11 | NA | 0.34 | 0.31 | NA |
Conclusion
The general industry success rates and LOA for phase I is 64%, for Phase 2 30%, and for phase 3 60% while the LOA from phase I is 10%. These data are published by Michael Hay and co-authors in Nature in January 2014. The success rates in UC drug development are therefore higher than the overall industry success rates.