0001140361-19-010950.txt : 20190613 0001140361-19-010950.hdr.sgml : 20190613 20190613090012 ACCESSION NUMBER: 0001140361-19-010950 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20190613 FILED AS OF DATE: 20190613 DATE AS OF CHANGE: 20190613 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InflaRx N.V. CENTRAL INDEX KEY: 0001708688 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: P7 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38283 FILM NUMBER: 19894976 BUSINESS ADDRESS: STREET 1: WINZERLAER STR. 2 CITY: JENA STATE: 2M ZIP: 07745 BUSINESS PHONE: 49 3641 508180 MAIL ADDRESS: STREET 1: WINZERLAER STR. 2 CITY: JENA STATE: 2M ZIP: 07745 FORMER COMPANY: FORMER CONFORMED NAME: Fireman B.V. DATE OF NAME CHANGE: 20170606 6-K 1 form6k.htm 6-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM 6-K



Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934

June, 2019

Commission File Number: 001-38283



InflaRx N.V.



Winzerlaer Str. 2
07745 Jena, Germany
(+49) 3641 508180
(Address of principal executive offices)



Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐



INFLARX N.V.

On June 13, 2019, InflaRx N.V. issued a press release titled “InflaRx Treats First Patient in Phase IIa Clinical Trial with Lead Candidate IFX-1 in Pyoderma Gangraenosum.”

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Jena, Germany, June 13, 2019.

 
INFLARX N.V.
   
 
By:
/s/ Niels Riedemann
 

Name: Niels Riedemann
 

Title: Chief Executive Officer
3

EXHIBIT INDEX

Exhibit
 
Description of Exhibit
 
Press release dated June 13, 2019


4
EX-99.1 2 ex99_1.htm EXHIBIT 99.1

Exhibit 99.1


InflaRx Treats First Patient in Phase IIa Clinical Trial with Lead

Candidate IFX-1 in Pyoderma Gangraenosum


Pyoderma Gangraenosum is a debilitating, rare autoimmune disease marked by large, painful skin ulcers

Jena, Germany, June 13, 2019 – InflaRx N.V. (Nasdaq: IFRX), an innovative biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the treatment of the first patient in a phase IIa clinical trial evaluating the Company’s lead product candidate, IFX-1, in Pyoderma Gangraenosum.

Pyoderma Gangraenosum (PG) is a rare and debilitating neutrophilic-driven, autoinflammatory disease, characterized by an acute, destructive ulcerating process of the skin, primarily occurring on the legs. The exact prevalence of PG is not yet known, but it is estimated that up to 50,000 patients in the US and Europe are affected by this disease.

This open-label phase IIa proof-of-concept study is planned to enroll approximately 12 patients with moderate to severe PG. The study is anticipated to initially be conducted at three sites in Canada. Patients will be treated with IFX-1 for 12 weeks with a three-month follow-up period. The main objectives of the study are the evaluation of the safety and efficacy of IFX-1 in patients with PG. Efficacy will be evaluated by a responder rate defined as Physician Global Assessment ≤3 of the target ulcer at various timepoints and time to complete closure of the target ulcer. Both endpoints will be compared with historical data. Additional clinical endpoints include a photographic documentation and analysis of the ulcer size and several patient-reported outcome parameters, such as pain score and Dermatology Life Quality Index (DLQI).

The Company is pleased to have Dr. Alavi as one of the leading scientists as principle investigator for this study.  “Pyoderma Gangraenosum is a debilitating disease with limited treatment options,” stated Afsaneh Alavi, M.D., Assistant Professor of Dermatology, University of Toronto, Canada and principal investigator of the trial. “A high medical need exists to develop new treatments, especially ones with novel modes of action. We look forward to seeing the results from this trial with IFX-1 in this patient population.”


About IFX-1:
IFX-1 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, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with IFX-1 in clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various inflammatory indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis and Pyoderma Gangraenosum.

About InflaRx N.V.:
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator involved 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 and New York, NY, USA.  For further information please visit www.inflarx.com.

Contacts:

Investor Relations
InflaRx N.V.
Jordan Silverstein
Head of Corporate Development and Strategy
Jordan.silverstein[at]inflarx.de
+1 917-837-1709

Media Relations
MC Services AG
Katja Arnold, Laurie Doyle, Andreas Jungfer
inflarx[at]mc-services.eu
+49 89-210 2280


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,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks uncertainties and other factors described under the heading “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 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.


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