No significant treatment effect found for IFX-1 in hidradenitis suppurativa trial

IFX-1, a monoclonal anti-human complement factor C5a antibody, showed no significant dose response in patients with hidradenitis suppurativa at week 16 of the SHINE phase 2b study.

The treatment blocks the biological activity of C5a and leaves the formation of the membrane attack complex intact as a defense mechanism, according to a press release from InflaRx.

One hundred seventy-nine patients participated in the randomized, double-blind, placebo-controlled, multicenter study. Four active dosing arms and a placebo arm were studied to ascertain a dose response signal according to the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16. The four dosing regimens for treatment with IFX-1 were a minimal dose of 400 mg every 4 weeks, a low dose of 800 mg every 4 weeks, a medium dose of 800 mg every 2 weeks and a high dose of 1,200 mg every 2 weeks. Placebo was administered every 2 weeks.

At week 16, there was a statistically significant reduction in the Dermatology Life Quality Index (DLQI) in the overall treatment arms compared with the placebo arm.

The medium dose group showed the highest median DLQI reduction of –5.5 points at week 16 compared with baseline values and –1.5 points compared with the placebo group.

The median reduction in inflammatory nodule count was –5.0 in the low dose group, –5.0 in the medium dose group and –4.5 in the high dose group. The placebo group had a mean reduction of –3.0.

No differences in treatment emergent adverse events were reported between the groups.

“We are disappointed that we were not able to demonstrate a significant signal on dose response for the treatment with IFX-1. While we are still analyzing additional data, we note that the trial demonstrated an unusually high placebo HiSCR rate at week 16,” Othmar Zenker, MD, chief medical officer of InflaRx, said in the release.

IFX-1, a monoclonal anti-human complement factor C5a antibody, showed no significant dose response in patients with hidradenitis suppurativa at week 16 of the SHINE phase 2b study.

The treatment blocks the biological activity of C5a and leaves the formation of the membrane attack complex intact as a defense mechanism, according to a press release from InflaRx.

One hundred seventy-nine patients participated in the randomized, double-blind, placebo-controlled, multicenter study. Four active dosing arms and a placebo arm were studied to ascertain a dose response signal according to the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16. The four dosing regimens for treatment with IFX-1 were a minimal dose of 400 mg every 4 weeks, a low dose of 800 mg every 4 weeks, a medium dose of 800 mg every 2 weeks and a high dose of 1,200 mg every 2 weeks. Placebo was administered every 2 weeks.

At week 16, there was a statistically significant reduction in the Dermatology Life Quality Index (DLQI) in the overall treatment arms compared with the placebo arm.

The medium dose group showed the highest median DLQI reduction of –5.5 points at week 16 compared with baseline values and –1.5 points compared with the placebo group.

The median reduction in inflammatory nodule count was –5.0 in the low dose group, –5.0 in the medium dose group and –4.5 in the high dose group. The placebo group had a mean reduction of –3.0.

No differences in treatment emergent adverse events were reported between the groups.

“We are disappointed that we were not able to demonstrate a significant signal on dose response for the treatment with IFX-1. While we are still analyzing additional data, we note that the trial demonstrated an unusually high placebo HiSCR rate at week 16,” Othmar Zenker, MD, chief medical officer of InflaRx, said in the release.