Jena, Germany, September 25, 2024 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced the e-poster presentation of a post hoc analysis of the SHINE Phase 2b study of its first-in-class anti-C5a antibody, vilobelimab, in hidradenitis suppurativa (HS) at the 2024 European Academy of Dermatology and Venereology (EADV) Congress being held in Amsterdam, September 25 – 28, 2024.

Camilla Chong, MD, Chief Medical Officer of InflaRx, commented: “This analysis sheds significant light on the role of C5a/C5aR signaling and vilobelimab’s ability to address the underlying inflammation driving hidradenitis suppurativa (HS), including its potential to reduce not only abscesses and nodules, but draining tunnels that remain a significant burden for many patients with this debilitating disease. In addition, we believe exploring additional efficacy parameters for HS in addition to HiSCR (Hidradenitis Suppurativa Clinical Response) could lead to a greater understanding of the disease-modifying potential of C5a inhibitors such as vilobelimab and C5aR inhibitors such as INF904, particularly with regard to reducing draining tunnels.”

E-poster: P0063

Vilobelimab demonstrates significant improvement in reduction of draining tunnels, total lesion count, International Hidradenitis Suppurativa Score 4 and the newly introduced modified-HiSCR: a post hoc analysis of the Phase IIb SHINE study

Authors

Evangelos J. Giamarellos-Bourboulis, Christopher Sayed, Jamie Weisman, Jacek Szepietowski, Falk Bechara, Niels C. Riedemann, Camilla Chong, Hoda Tawfik

SHINE was a prospective, randomized, placebo-controlled, double-blind multicenter Phase 2b trial in 177 patients with moderate to severe HS, with results announced in 2019. The post hoc analysis presented at EADV 2024 looked at other important clinical efficacy endpoints and, in particular vilobelimab 1200 mg, which was statistically significant compared to placebo at 16 weeks. Efficacy parameters assessed included the reduction of draining tunnels (dT), reduction of total lesion counts (abscesses + nodules + draining tunnels (ANdT)) and the International Hidradenitis Suppurativa Score 4 (IHS4) compared to placebo.

In this post hoc analysis, vilobelimab 1200 mg demonstrated a placebo-adjusted significant reduction in dT, ANdT, and IHS4 of 45.2%, 25.1% and 31.6%, respectively. InflaRx believes this analysis suggests meaningful clinical benefit for vilobelimab in HS. Further, it supports utilizing a modified version of the HiSCR that measures drug activity against all three lesion types with an emphasis on the reduction of dT, a critical manifestation of the disease that greatly impacts patients’ quality of life.

About GOHIBIC (vilobelimab)

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. In addition to development in COVID-19, vilobelimab is also being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG).

In April 2023, the FDA issued the EUA for GOHIBIC (vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). In January 2024, InflaRx announced the launch of The InflaRx Commitment Program, pursuant to which the cost of GOHIBIC (vilobelimab) will be refunded for up to six (6) administered inpatient doses (the full treatment course) to institutions that meet the eligibility requirements, for patients who were administered GOHIBIC (vilobelimab) in line with its EUA and who died due to COVID-19 in the intensive care unit.

The Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving IMV or ECMO is under regulatory review by the European Committee for Medicinal Products for Human Use under the centralized procedure, which applies to all 27 member states of the European Union.

About InflaRx

InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is also developing INF904, an orally administered, small molecule inhibitor of the C5a receptor. 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 further information, please visit www.inflarx.com.

InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

Contacts:

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 terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the heading “Risk Factors” and “Cautionary statement regarding forward looking statements” in our periodic filings with the U.S. 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 be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given 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.

Download PDF