InflaRx IFX-1 misses primary endpoint in Phase 2b hidradenitis suppurativa trial
InflaRx (NASDAQ:IFRX) reported that IFX-1 missed its primary endpoint in a Phase 2b trial in hidradenitis suppurativa (HS) patients.
HS a chronic inflammatory skin disease that causes abscesses and scarring. IFX-1 is a monoclonal anti-human complement factor C5a antibody designed to control the inflammatory response.
Although IFX-1 failed to meet its primary endpoint of a dose-dependent effect on HS clinical response score (HiSCR), treatment in the high-dose group resulted in multiple efficacy signals.
“Our in depth post-hoc data analysis suggests a robust anti-inflammatory activity in the high dose IFX-1 treatment group across numerous efficacy measures which were not reflected by the HiSCR,” Niels Riedemann, InflaRx’s CEO and founder, said in a statement.
“The company has made significant efforts to research the available data set and has engaged with U.S. and European experts to assist in the analysis and interpretation of these findings. Based on this, our team continues to work on the development of IFX-1 in HS,” he added.
The ongoing trial expects to dose its last patient in August 2019, after which InflaRx plans to discuss IFX-1’s potential for further development for HS with regulatory authorities.