Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

Trial failure

Inability to meet any primary outcome:
Phase 1 and 2 trials one of the primary outcomes is always safety. Failure to meet agreed upon safety measures always leads to trial failure with a possibility of redesign and repeat the level of trial once safety issues are addressed. A good example of this was Brilacidin ABSSSI Phase 1 where there were two safety issues cited. The doses were lowered and the escalation trial redesigned as a Phase 2b.

However, one should note that "safety" is rather a squirrelly notion, one that shifts with mortality of the disease or condition and the toxicity and reactions to the drug when administered. Cancer drugs might have rare side effects that can lead to death, yet may still be considered acceptable against he mortality rate of a particular cancer with few or no treatment options. An antibiotic, on the other hand, with plenty of options, might fail due to something as simple as elevated blood pressure and rare cases of kidney damage.

It's seldom that a trial fails when secondary outcomes are not met, except when they are safety outcomes for late stage trials. Vaccines often fail for this reason. A dengue vaccine, a few years back, failed after administration of 25000 doses in a Phase 3 trial. Seems some of the vaccines, I believe 5 doses that were administered, gave subjects dengue who subsequently died.