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LONDON, UK / ACCESSWIRE / March 12, 2018 / Active-Investors.com has just released a free research report on InflaRx N.V. (NASDAQ: IFRX). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=IFRX as the Company's latest news hit the wire. On March 08, 2018, the Company announced that it has enrolled first patient in its Phase-IIb trial of IFX-1, a first-in-class anti-human complement factor C5a antibody, in patients suffering from moderate or severe Hidradenitis Suppurativa (HS), a painful, chronic and debilitating inflammatory skin disease. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Objective of Phase-IIb Trial is to Evaluate Dose Response Signa Assessed by HiSCR Score at Week 16
The randomized, double-blind, placebo-controlled, multicenter study will enroll around 175 patients in five-dose groups and will be conducted in 50 sites in several countries including the United States, Germany, Greece, Denmark, and the Netherlands. After a placebo-controlled, double-blind period of 16 weeks, the trial will be extended to a 28-week open-label extension phase to assess long-term efficacy and safety.
The main objective of the study is the evaluation of a dose response signal, assessed by the Hidradenitis Suppurativa Clinical Response (HiSCR) score at week 16 as the primary endpoint. This score is defined as a reduction of 50% or higher in inflammatory lesion count (abscesses and inflammatory nodules) and no increase in abscesses or draining fistulas when compared with baseline. Additional objectives of the study include the evaluation of safety and tolerability of IFX-1 as well as an assessment of additional efficacy and patient-reported outcome parameters.
InflaRx Received IND Acceptance to Proceed with Phase IIb Trial of IFX-1 in HS
On January 09, 2018, the Company announced the acceptance of their Investigational New Drug (IND) application by the US Food and Drug Administration (FDA). The open IND allowed InflaRx to conduct a phase-IIb study to determine efficacy and safety of IFX-1 in patients with moderate or severe HS.
InflaRx Reported Top-line Phase-IIa Clinical Results of IFX-1 for the Treatment of HS in 2017
In September 2017, the Company released positive top-line data from an exploratory Phase-IIa clinical trial of IFX-1 in patients suffering from moderate to severe HS. The Phase-IIa study was conducted to primarily assess the safety and tolerability of IFX-1 in HS patients. The trial recruited 12 patients with moderate to severe HS, who were not eligible for or failed to respond to previous therapy with biologicals. Patients were treated with weekly intravenous injections of IFX-1 for eight consecutive weeks and were then followed up for an additional period of 12 weeks. Initial efficacy of treatment was assessed through response rate measured by the validated and clinically relevant HiSCR score.
Assessment of the HiSCR score demonstrated a response rate of 75% at the end of the treatment period and 83% at the end of 12-week follow-up period. The weekly intravenous infusions of IFX-1 were well tolerated. No drug-related adverse events were detected, and no infusion-related, allergic, or anaphylactic reactions were observed.
FDA Approved Drugs for Treatment of HS
In September 2015, FDA approved the tumor necrosis factor inhibitor adalimumab (Humira, AbbVie) for the treatment of moderate to severe HS, making it the first FDA-approved therapy for HS. Adalimumab is recommended as a first-line treatment option in patients with HS who were unresponsive to or intolerant of oral antibiotics. Currently, only adalimumab is approved by the FDA for the treatment of HS.
About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa, also known as acne inversa, is a long-term skin disease characterized by the occurrence of inflamed and swollen lumps. These are typically painful and break open releasing fluid or pus. The most commonly affected areas are the underarms, under the breasts, and groin. After healing scar tissue remains, and it can result in self-consciousness or depression.
IFX-1 is a first-in-class monoclonal anti-complement factor C5a antibody which offers a complete biological blocking activity and high selectivity towards its target, C5a in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact to work 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.
About InflaRx N.V.
Founded in 2007 and headquartered in Jena, Germany, InflaRx, a clinical-stage biopharmaceutical company, focuses on discovering and developing inhibitors using C5a technology in the United States. Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases.
Stock Performance Snapshot
March 09, 2018 - At Friday's closing bell, InflaRx's stock was marginally up 0.14%, ending the trading session at $28.21.
Volume traded for the day: 85.01 thousand shares, which was above the 3-month average volume of 58.84 thousand shares.
Stock performance in the last month – up 24.00%; previous three-month period – up 60.47%; and year-to-date - up 34.65%
After last Friday's close, InflaRx's market cap was at $654.19 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.3% at the end of the session.
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