Vilobelimab Clinical Development - Vilobelimab's pivotal Phase III study for Hidradenitis Suppurativa (HS) was initiated in Q1 2022, based on FDA feedback[5] - Phase III trial enrollment for severe COVID-19 was completed, with topline data expected in Q1 2022[5] - Positive Phase IIa data for Pyoderma Gangraenosum (PG) was achieved, prompting the company to seek regulatory advice for a pivotal program[5] - In a Phase II study of PG, 9 out of 17 evaluable patients (53%) achieved clinical remission (PGA ≤ 1) at the end of the treatment visit or day of last drug administration, and an additional 1 patient (6%) achieved clinical response (PGA ≤ 3)[42] - The high dose group in the PG Phase IIa study showed the highest rate of target ulcer closure and clinical remission at 857%[42] Pipeline and Technology - InflaRx has proprietary anti-C5a technology with patent protection until the end of 2030/2035 with extension[5] - A new program, INF904, an oral C5aR inhibitor, is planned to enter the clinic in H2 2022[5] - INF904 shows a high in vitro potency with a desired IC50 (<1nM) in calcium mobilization assay[58] Hidradenitis Suppurativa (HS) Program - The Phase III study in HS targets moderate to severe Hurley stage II-III patients with at least one active draining tunnel, estimated to be approximately 70-75% of Hurley stage II-III moderate to severe study patients[14] - In a subgroup of moderate to severe Hurley stage II-III patients with at least 1 draining tunnel at baseline, 545% of the 1200mg Q2W vilobelimab group achieved m-HiSCR response at Week 16, compared to 261% in the placebo group (p=00424)[23] Financial Status - The company reported a strong cash balance of €1206 million as of September 30, 2021[59]
InflaRx (IFRX) Presents At Annual SVB Leerink Global Health Conference