InflaRx flatlines after skin disease drug flops in midstage trial

The phase 2b SHINE study of the anti-human complement factor C5a antibody was conducted in hidradenitis suppurativa (HS), a chronic inflammatory skin disease with limited treatment options that causes symptoms including inflamed nodules or boils in the armpits, groin and genital area. Unfortunately for InflaRx, the 179-patient study appears to be a near-total bust, with IFX-1 showing no improvement over placebo on symptoms after 16 weeks’ treatment. Most worryingly, there was no evidence of any dose response with the four IFX-1 dose levels tested, which was the trial’s primary endpoint, and the responses were significantly lower than had been previously reported in phase 2a. But for that earlier result it would be tempting to suggest that the primary problem is that C5a’s role in HS had been dramatically overstated. The only crumb of comfort for the Nasdaq-listed biotech came from a secondary endpoint – the dermatology life quality index (DLQI) – which just scraped a statistically significant improvement over placebo for the four IFX-1 groups as a whole.