Inflarx pushes past the red flags to claim a win

Anyone with more than a fleeting experience of biotech investment should be familiar with the practice of post-hoc data dredging of a failed clinical trial to find hints of activity. Inflarx’s claim yesterday that its clearly negative study of IFX-1 in hidradenitis suppurativa did, after all, show robust efficacy is a particularly egregious example of this. Inflarx has moved to cast doubt on the HiSCR measure – its study’s primary endpoint, and the metric on which Abbvie’s Humira got a hidradenitis suppurativa label – and instead now tells investors to look at reduction of draining fistulas as evidence of activity. It backs this by carving out a subset of subjects with at least one draining fistula at baseline, given the highest IFX-1 dose, and claims that these yield a p value of 0.036 versus placebo. Inflarx seems to have carried out multiple post-hoc analyses to arrive at one that gave a nominal p value below 0.05, and despite the fact that this new result is meaningless until proved prospectively it calls it “statistically significant”. It is a given that this and other “multiple efficacy signals” are enough for the company to continue developing IFX-1. Caveat emptor.

IFX-1 effect on reduction of draining fistulas at 16 weeks in the Shine study.
Note: one of multiple post-hoc analyses, looking at subgroup (n unspecified) with at least 1 draining fistula at baseline; primary endpoint failed; p value nominal.

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