Until further detail is revealed it is difficult to gauge just why Inflarx’s Shine trial failed so spectacularly today, but one possible reason is that the complement factor C5a has no involvement in hidradenitis suppurativa, the skin scarring condition in question. Shine had tested four doses of Inflarx’s lead project, the anti-C5a MAb IFX-1, and had attempted to use multiple comparison procedure modelling to demonstrate a dose-response relationship as well as a drug effect. The premise was that C5a’s pro-inflammatory properties, such as inhibiting Tregs, cause immune system balance disruption that might contribute to hidradenitis suppurativa. In the event nothing of the sort was shown, and all four doses were in line with placebo. Inflarx today crashed 85%, while Chemocentryx, whose Avacopan uses a similar approach in hidradenitis suppurativa, was off 25%. Inflarx blamed a high placebo response, and claimed that the combined treatment cohorts yielded a reduction in a secondary endpoint, the dermatology quality of life index, versus placebo, though the p value of 0.031 is surely nominal given the primary endpoint fail. Investors should probably brace themselves for an upcoming datadredge.
|Inflarx Shine study (NCT03487276) summary|
|Cohort||16wk hidradenitis suppurativa clinical response score|
|IFX-1 400mg Q4W||40.0%|
|IFX-1 800mg Q4W||51.5%|
|IFX-1 800mg Q2W||38.7%|
|IFX-1 1,200mg Q2W||45.5%|
|Source: SEC filing.|