InflaRx stock crashes on study failure in HS

InflaRx stock crashes on study failure in HS

US-listed German biotech InflaRx (Nasdaq: IFRX) saw its stock fall by 89% earlier today on the failure of a Phase IIb study of its lead product, IFX-1, in moderate to severe hidradenitis suppurativa (HS), a painful and chronic inflammatory skin disease. The study enrolled 179 patients who were randomised to one of four IFX-1 doses or placebo and used the Hydradenitis Suppurativa Clinical Response (HiSCR) score at week 16 as the primary endpoint. The primary statistical analysis showed no significant dose response for the IFX-1 treatment.

The study did show a statistically significant reduction of the dermatology life quality index (DLQI) when comparing the overall treatment arms with the placebo arm at week 16 (p=0.031), but this must be treated as notional given the failure of the primary endpoint.

The outcome of the study was unexpected, with InflaRx held by a number of influential and sophisticated US healthcare specialist investors, such as Adage, RA Capital and Cormorant Asset Management. InflaRx’s market cap is now $99m and the company will have to determine a new strategy going forward (it held cash of €47m ($53m) as of March 31). InflaRx is currently also testing IFX-1, which is a monoclonal anti-human complement factor C5a antibody, in smaller trials in several other indications: granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), which are related systemic anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) and pyoderma gangrenosum, an immune system condition that causes ulcers to form on the skin.

Abbvie’s Humira is the only drug approved for HS. There are around 10 other industry development programmes for the condition, the majority of which are biologicals (such as Humira and IFX-1) that must be given by injection. Two are, however, orally available: the JAK1 inhibitor from Incyte (INCB054707) and a high CBD containing cannabis oil from TO Pharmaceuticals. The outcome of Incyte’s study in HS – due in November this year – will likely be of interest to London-listed Sareum (SAR), which has a dual TYK2/JAK1 inhibitor, SDC1801, in late preclinical development and is evaluating potential indications for the compound’s future development.