Clinical Programs & Pipeline - Vilobelimab's clinical efficacy and safety profile enable advancement in multiple indications, including Hidradenitis Suppurativa (HS), Pyoderma Gangraenosum (PG), Severe COVID-19, ANCA-associated vasculitis (AAV), and Cutaneous squamous cell carcinoma (cSCC)[5] - A pivotal study program in HS was initiated in Q1 2022 after receiving no comments from the FDA in the 30-day review period[5] - Positive Phase IIa data was reported for PG, and the company is gathering regulatory input on next steps for a pivotal program[5] - Phase III enrollment for Severe COVID-19 was completed, with topline data expected in Q1 2022[5] - A new program involving the oral C5aR inhibitor INF904 is expected to enter the clinic in H2 2022[5] Hidradenitis Suppurativa (HS) - Likely more than 200,000 moderate to severe (Hurley II+III) HS patients in the US, with higher prevalence reported in Europe at >1% total HS prevalence[11] - Approximately 50% of patients with moderate to severe HS do not respond, and about 50% of responder patients lose response to Humira[11] - The FDA provided feedback supportive of a new primary endpoint measuring reductions in all three inflammatory HS lesions, including Draining Tunnels[14] Pyoderma Gangraenosum (PG) - An estimated 50,000 patients in the US and Europe are affected by PG[15] - In a Phase IIa study, out of 17 evaluable patients, 9 patients (53%) achieved clinical remission (PGA ≤ 1), and 1 additional patient (6%) achieved a clinical response (PGA ≤ 3)[24] - The high dose group in the PG Phase IIa study showed the highest rate of target ulcer closure and clinical remission (857%)[24] Financial Status - The company had a strong cash balance of €1206 million as of September 30, 2021, to pursue strategic activities[41]
Inflarx (IFRX) Investor Presentation - Slideshow