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InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination with Other Immunomodulators Jena, Germany

Key Takeaway: InflaRx recently presented new post-hoc analysis data from their PANAMO Phase III trial at the ATS 2024 International Conference. The analysis highlights the combined use of vilobelimab with tocilizumab or baricitinib in critically ill COVID-19 patients, showing an 84.6% reduction in 28-day all-cause mortality rates. This combination therapy not only demonstrated improved mortality outcomes but was also deemed safe without significant concerns. InflaRx emphasizes vilobelimab's potential life-saving role in acute COVID-19 care and outlines ongoing developments in various inflammatory conditions.

Market Sentiment Analysis

POSITIVE FACTORS

  • Significant mortality reduction observed in patients treated with vilobelimab.
  • Safety assessments indicate no new safety concerns with the combination therapy.
  • The potential life-saving implications of vilobelimab in critically ill COVID-19 patients are highlighted.

CONCERNS & RISKS

  • GOHIBIC (vilobelimab) is still an investigational drug and not FDA approved for any indication.
  • Limited clinical data available raises concerns about the safety and effectiveness of vilobelimab.

Full Press Release Details

InflaRx Presents New Analysis of PANAMO Phase
III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination with Other Immunomodulators
Jena, Germany, May 21, 2024 -
InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system,
announced data presented at the American Thoracic Society (ATS) 2024 International Conference that is being held from May 17-22,
InflaRx is presenting a poster at the
thematic poster session at the ATS conference today from 11:30 AM PT / 2:30 PM ET to 1:15 PM PT / 4:15 PM ET. The poster is titled, "Vilobelimab
in Combination with Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients" and is being
presented during the "ARDS and Acute Respiratory Failure: Mechanism, Risk, and Outcomes" thematic poster session.
The data being presented is derived
from a post-hoc subgroup analysis of the PANAMO Phase III global study, one of the largest 1:1 randomized, double-blind placebo-controlled
trials in invasively mechanically ventilated (IMV) COVID-19 patients in intensive care units in adult critically ill COVID-19 patients.
Tocilizumab, an anti-IL6R antibody, and baricitinib, a JAK inhibitor, are immunomodulators used in some patients as part of the standard
of care treatment in this trial. PANAMO included a total of 369 patients and was used to support the emergency use authorization (EUA)
granted by the U.S. Food and Drug Administration (FDA) in April 2023 for GOHIBIC (vilobelimab) for the treatment of critically ill COVID-19
The analysis presented at ATS 2024 is
comprised of 71 patients from PANAMO that assessed 28- and 60-day all-cause mortality in the subgroup of patients taking the combination
of vilobelimab plus tocilizumab or baricitinib versus patients on placebo plus tocilizumab or baricitinib. All patients received standard
of care. Safety was also assessed.
The point estimate for 28-day all-cause
mortality was 6.3% in the vilobelimab plus tocilizumab or baricitinib arm, and 40.9% in the placebo plus tocilizumab or baricitinib arm:
this is a significant relative reduction of 84.6% (HR 0.13; 95% CI:0.03-0.56, p=0.006) between the two arms. Day 60 all-cause mortality
was 16.4% and 49.3%, respectively (HR 0.25; 95% CI:0.09-0.68, p=0.006), a significant relative reduction.
The co-administration of vilobelimab
with baricitinib or tocilizumab was not associated with safety concerns. In addition, demographics of these subgroups were generally well-balanced
and comparable to the overall study population.
Camilla Chong, MD, Chief Medical
Officer of InflaRx, commented: "I am thrilled that we can share this additional data from the PANAMO study, which will provide
further scientific insights into the utility of vilobelimab when used with tocilizumab and baricitinib in critically ill hospitalized
COVID-19 patients. We believe this analysis further supports the life-saving potential of vilobelimab in the acute care setting and indicates
our continued commitment to these patients."
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 and cutaneous squamous cell carcinoma.
Important Information about GOHIBIC
Vilobelimab has been granted an EUA
for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or extracorporeal membrane oxygenation.
The emergency use of GOHIBIC (vilobelimab)
is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs
and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration
is terminated, or authorization revoked sooner.
Vilobelimab is an investigational drug
that has not been approved by the FDA for any indication including for the treatment of COVID-19. There is limited information known about
the safety and effectiveness of using GOHIBIC (vilobelimab) to treat people in the hospital with COVID-19. Please see additional information
in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC
(vilobelimab) website (www.GOHIBIC.com).
Important Safety Information about
GOHIBIC (vilobelimab)
There is limited clinical data available
for GOHIBIC (vilobelimab). Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC (vilobelimab)
GOHIBIC (vilobelimab) has been associated
with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment
with GOHIBIC (vilobelimab). Hypersensitivity reactions have been observed with GOHIBIC (vilobelimab). If a severe hypersensitivity reaction
occurs, administration of GOHIBIC (vilobelimab) should be discontinued and appropriate therapy initiated.
The most common adverse reactions (incidence
3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal
infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum,
respiratory tract infection, supraventricular tachycardia, constipation, and rash.
Healthcare providers and/or their designee
are responsible for mandatory FDA MedWatch reporting of all medication errors and serious AEs or deaths occurring during GOHIBIC (vilobelimab)
treatment and considered to be potentially attributable to GOHIBIC (vilobelimab).
Report side effects to the FDA at 1-800-FDA-1088
or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de
For the full prescribing information and
additional important safety information, please visit www.GOHIBIC.com
InflaRx GmbH (Germany) and InflaRx Pharmaceuticals
Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, 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 C5a-induced signaling via 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.de.
InflaRx N.V. MC Services AG
Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752
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 and current expectations concerning, among other things,
the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendations
by medical/healthcare institutes and other third-party organizations, our ability to successfully commercialize and the receptiveness
of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations
regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return
accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indication or for vilobelimab and any other
product candidates, under an EUA and in the future if approved for commercial use in the U.S. or elsewhere; our ability to successfully
implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab's treatment of COVID-19 and
other debilitating or life-threatening inflammatory indications, including PG, and any other product candidates, including INF904, and
whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing,
progress and results of pre-clinical studies and clinical trials of our product candidates and statements regarding the timing of initiation
and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available,
the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of
clinical trials and potential regulatory approval pathways, including related to our Marketing Authorization Application submission for

Frequently Asked Questions

What did InflaRx present at the ATS 2024 conference?

InflaRx presented data on vilobelimab's effectiveness in combination with tocilizumab or baricitinib in critically ill COVID-19 patients.

What is the purpose of the PANAMO Phase III trial?

The PANAMO trial aims to evaluate vilobelimab's impact on mortality in mechanically ventilated COVID-19 patients.

What were the 28-day mortality results for vilobelimab?

The 28-day mortality rate was 6.3% for vilobelimab patients, compared to 40.9% for the placebo group.

Is vilobelimab approved for COVID-19 treatment?

Vilobelimab is an investigational drug with emergency use authorization but not fully FDA approved.

What safety concerns are associated with vilobelimab?

Vilobelimab may cause serious infections or hypersensitivity reactions in patients.

Last updated: May 21, 2024