InflaRx N.V.(US:IFRX)2020-03-03 13:15Investment Highlights - InflaRx's anti-C5a technology has strong patent coverage until the end of 2030/2035 with extension[4] - IFX-1 has demonstrated a statistically significant reduction of inflammatory lesions in a Phase IIb Hidradenitis Suppurativa study[4] - InflaRx is conducting multiple ongoing Phase IIb studies in ANCA-associated vasculitis in the US and EU[5] - InflaRx is also conducting an ongoing Phase IIa open label study in Pyoderma Gangraenosum in the US and Canada[5] SHINE Study (Hidradenitis Suppurativa) - In the SHINE study, the primary endpoint (HiSCR dose response) was not met, but there was a signal towards improved AN count[4, 15] - At week 16, HiSCR response rates varied across treatment groups, ranging from 38.7% to 51.5%[14] - A statistically significant change in draining fistula (DF) and IHS-4 scores was detected at week 16 (p=0.0359 and p=0.0202, respectively)[16] - In the Open Label Extension (OLE) period, 71% of responders maintained HiSCR response with a low dose of IFX-1 (800 mg q4w), while 42% of non-responders became HiSCR responders with a medium dose of IFX-1 (800 mg q2w)[17] - At week 40, OLE patients showed a marked improvement in all inflammatory lesions compared to the placebo group at week 16[18, 20] Pyoderma Gangraenosum (PG) Study - In the Phase IIa study in PG, 2 out of the first 5 patients showed complete closure of the target ulcer, with one patient in full disease remission[27] - The responders in the PG study had higher baseline C5a levels[27] Strategy - InflaRx had a strong cash balance of US$151 million at the end of Q3 2019 to pursue its activities[31]