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InflaRx Receives FDA Fast Track Designation for Treatment

  • U.S. Food and Drug Administration Awards Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum
  • Fast Track Follows Orphan Drug Designation Recently Reported by US FDA and EMA

JENA, Germany, 06 Jul. 10, 2022 (GLOBE NEWSWIRE) — InflaRx NV (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that the Food and Drug Administration (FDA) has granted a Fast Track designation for the development of its first anti-C5a monoclonal antibody, vilobelimab, for the treatment of ulcerative pyoderma gangrenosum (PG). The company had submitted an application for Fast Track designation to the FDA based on positive results in PG from its open-label, dose-escalating Phase IIa study.

As previously announced, in the phase IIa multicenter proof-of-concept study, a total of 19 patients were enrolled. Over a 26 week treatment period, patients were treated every other week with vilobelimab 800 mg, 1600 mg or 2400 mg, following an initial run-in phase with three 800 mg doses on days 1, 4 and 8, followed by a two-month observation period. Efficacy was assessed with the Physician’s Global Assessment (PGA) score, and 6 of 7 (85.7%) patients in the high-dose cohort demonstrated complete target ulcer closure and response to treatment correlated with suppression of C5a levels in patients’ plasma over time.

The Company previously announced that vilobelimab had been granted Orphan Drug Designation for the treatment of PG by the FDA in the United States and the European Medicines Agency (EMA) in Europe and that the Company had held a meeting end-of-Phase II productive with the Division of Dermatology with the FDA regarding its Phase III development plans in PG.

“We are delighted that our development in pyoderma gangrenosum has been designated Fast Track by the FDA shortly after receiving Orphan Drug Designation, recognizing PG as a serious disease with high unmet medical need and vilobelimab as a promising potential future treatment option,” said Professor Niels. C. Riedemann, CEO and Founder of InflaRx. “The Fast Track designation will further facilitate our interactions with the FDA related to our development in PG and will also allow for faster review and approval following the successful completion of a Phase III development program,” he added.

About the expedited procedure1

The Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs intended to treat serious conditions and address an unmet medical need. According to the FDA, the goal is to get important new drugs to the patient sooner. A drug that receives Fast Track designation is eligible for some or all of the following:

  • more frequent meetings with the FDA to discuss the drug’s development plan and ensure the collection of appropriate data needed for drug approval;
  • more frequent written communications from the FDA on topics such as the design of proposed clinical trials and the use of biomarkers;
  • eligibility for Accelerated approval and priority review, if the relevant criteria are met; and
  • Ongoing reviewmeaning that a pharmaceutical company can submit completed sections of their Biological License Application (BLA) or New Drug Application (NDA) for FDA review, rather than waiting for each section of the NDA to be completed before the entire application can be reviewed.

About vilobelimab

Vilobelimab is a first-in-class anti-human complement factor C5a monoclonal antibody, which potently and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves intact the formation of the membrane attack complex (C5b-9) as an important defense mechanism, which is not the case for the molecules blocking the cleavage of C5. Vilobelimab has been shown in preclinical studies to control tissue and organ damage caused by the inflammatory response by specifically blocking C5a as a key ‘enhancer’ of this response. Vilobelimab is believed to be the first anti-C5a monoclonal antibody introduced into clinical development. Vilobelimab has been shown to be well tolerated in clinical trials in different disease settings. Vilobelimab is currently in development for various indications, including pyoderma gangrenosum and severe COVID-19. The Company recently reported positive Phase IIa results in PG and encouraging Phase III results in mechanically ventilated COVID-19 patients. Vilobelimab is also in phase II development for patients with cutaneous squamous cell carcinoma.

About InflaRx NV

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary technology to discover and develop potent, specific, first-in-class or best-in-class C5a and C5aR inhibitors. C5a and C5aR complements are potent inflammatory mediators implicated in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007 and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For more information, please visit www.inflarx.com.

contacts:

InflaRx SA
Email: [email protected]

MC Services SA
Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: [email protected]
Europe: +49 89-210 2280
USA: +1-339-832-0752

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by words such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”. , “could”, “intend”, “target”, “project”, “believe”, “estimate”, “predict”, “potential” or “continue” and similar expressions. Forward-looking statements appear at several places in this release and may include statements regarding our intentions, beliefs, projections, outlook, analyzes and current expectations regarding, among other things, our ongoing and planned preclinical development and clinical trials. , including the development of vilobelimab to treat pyoderma gangrenosum (PG) and severe COVID-19; the impact of the COVID-19 pandemic on us; the timing and our ability to commence and conduct clinical trials; potential results of current or potential future collaborations; our ability to make regulatory filings, obtain positive advice from regulatory authorities and obtain and maintain regulatory approvals for our product candidates; our position on intellectual property; our ability to develop business functions; expectations regarding clinical trial data; our results of operations, cash requirements, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operate; trends that may affect the industry or us; our status as a foreign private issuer; and the risks, uncertainties and other factors described under “Risk Factors” in InflaRx’s periodic filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to differ materially from the results, future performance or achievement expressed or implied by the forward-looking statements. In view of these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future. except as required by law. .

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1 See US Food and Drug Administration“Fast Track”, available online.