InflaRx reported the top-line results of the international SHINE Phase IIb study, which investigated IFX-1 in patients with moderate to severe Hidradenitis Suppurativa (HS), a chronic inflammatory skin disease.
SHINE was a randomized, double-blind, placebo-controlled, multicenter study and enrolled a total of 179 patients at over 40 sites in 9 countries in North America and Europe. The subjects were randomized to four active dose arms and a placebo arm. The primary endpoint of the trial was a dose response signal, assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16. IFX-1 did not demonstrate a statistically significant dose dependent effect on HiSCR rate at week 16. Treatment with IFX-1 resulted in a maximum HiSCR rate of 51.5 % at week 16, while placebo treatment resulted in a HiSCR rate of 47.1 %. IFX-1 was well tolerated. The most common treatment emergent adverse events were exacerbation of Hidradenitis Suppurativa and nasopharyngitis.
About Hidradenitis suppurativa
Hidradenitis suppurativa is a skin condition that causes small, painful lumps to form under the skin. The lumps can break open, or tunnels can form under the skin. The condition mostly affects areas where the skin rubs together, such as the armpits, groin, buttocks and breasts. Hidradenitis suppurativa tends to start after puberty. It can persist for many years and worsen over time, with serious effects on daily life and emotional well-being.
IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies.Source: InflaRx