- Quarter highlighted by progress with vilobelimab in several indications:
- Encouraging Phase III topline results reported in patients with severe COVID-19; discussions with regulatory authorities already underway
- Final data from Phase IIa open-label study in patients with pyoderma gangrenosum presented at 2022 AAD Annual Meeting; end-of-Phase II meeting with FDA scheduled for mid-2022
- In Phase II trial in cutaneous squamous cell carcinoma, second dosing cohort of combination arm started; enrollment in monotherapy arm continuing with 8 patients enrolled with data expected in Q3 2022
- Clinical development in hidradenitis suppurativa and ANCA-associated vasculitis halted for the time being
- Introduced new pipeline program, INF904, an oral small molecule inhibitor of C5aR; planned to enter the clinic later this year
- Cash, cash equivalents and financial assets of approximately €99.3 million as of March 31, 2022, expected to fund operations well into H2 2024
JENA, Germany, May 12, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three months ended March 31, 2022 and provided a business update.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “Following a recent internal strategic review, we are announcing the Company’s updated key priorities and strategy. With final data now available from our Phase IIa study, we intend to move vilobelimab into a pivotal program in pyoderma gangrenosum and advance INF-904, our small molecule C5aR inhibitor, into first-in-human testing this year. Additionally, with the encouraging topline Phase III results we saw with vilobelimab in treating severe COVID-19 patients, we are now discussing our data with regulatory authorities to assess a potential path towards approval. With all of these important activities, we decided to halt the Phase III program in hidradenitis suppurativa and not to advance vilobelimab in AAV for the time being to prioritize the best use of our resources. We are excited about InflaRx’s potential to develop effective new treatments to improve the lives of patients suffering from neutrophil-driven inflammatory diseases.”
Recent Highlights – Progress with Vilobelimab in Several Indications
Severe COVID-19: On March 31, 2022, InflaRx announced topline results from the Phase III part of the global Phase II/III PANAMO trial evaluating vilobelimab in mechanically ventilated patients with COVID-19. A total of 369 patients were enrolled. Vilobelimab treatment resulted in a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (vilobelimab 31.7% versus placebo 41.6%, p=0.094), which was not statistically significant using site-stratified Cox regression analysis as pre-specified in the final statistical analysis plan. At the recommendation of regulatory authorities, during the course of the trial, the Company changed the statistical analysis method for the primary endpoint. The original protocol-specified analysis would have resulted in a statistically significant p-value of 0.027. Additionally, logistic regression analyses of 28-day all-cause mortality resulted in p-values of