C5a

VFMCRP receives positive CHMP opinion for Tavneos® for the treatment of ANCA-associated vasculitis

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星期五, 十一月 12, 2021
Biotechnology, Pharmaceutical, Health, Fresenius Medical Care, SIX Swiss Exchange, Food, Neutrophil, Granulomatosis with polyangiitis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Rituximab, C5a, European Commission, Cell, European, Kidney, Infection, Failure, End organ damage, Cyclophosphamide, MPA, Standard of care, C5L2, HS, ISIN, Conditional sentence, Time, Nephrology, Patient, CHMP, Adult, ART, View, Receptor (biochemistry), Vasculitis, Inflammation, Union, Steroid, LR, Granuloma, Atypical hemolytic uremic syndrome, European Union, ANCA, EMA, Hidradenitis suppurativa, GPA, Death, Microscopic polyangiitis, Royal commission, European Medicines Agency, Vifor Pharma, Vaccine, Pharmaceutical industry, Vifor Pharma Group, ANCA-associated vasculitis, Tavneos® (avacopan), VIFOR PHARMA GROUP, ANCA-ASSOCIATED VASCULITIS, TAVNEOS® (AVACOPAN)

A positive opinion by the CHMP is a formal scientific recommendation supporting marketing authorization across the EU.

Key Points: 
  • A positive opinion by the CHMP is a formal scientific recommendation supporting marketing authorization across the EU.
  • CHMP Opinions are the basis for the European Commissions final Decision regarding marketing authorization for Tavneos, which is expected in Q1 2022.
  • Tavneos was developed by ChemoCentryx Ltd. who is also developing Tavneos for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS).
  • The U.S. Food and Drug Administration has granted Tavneos orphan-drug designation for ANCA-associated vasculitis, C3G and atypical hemolytic uremic syndrome.

InflaRx Announces Positive Data from Third Cohort of Phase IIa Open-Label Study with Vilobelimab in Pyoderma Gangraenosum

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星期三, 十月 27, 2021
Safety, Șaeș, Phase, PG, Global Assessment of Functioning, CEST, AE, Ulcer, C5a, Patient, FDA, Erysipelas, EDT, PGA, AES, Nasdaq, Hospital, Therapy, GLOBE, Rash, Pharmaceutical industry

JENA, Germany, Oct. 27, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the third cohort of patients in the Phase IIa open-label study with vilobelimab in Pyoderma Gangraenosum (PG).

Key Points: 
  • JENA, Germany, Oct. 27, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the third cohort of patients in the Phase IIa open-label study with vilobelimab in Pyoderma Gangraenosum (PG).
  • We are happy to see more patients responding with the highest dose of vilobelimab in patients with Pyoderma Gangraenosum, commented Dr. Korinna Pilz, Chief Clinical Development Officer of InflaRx.
  • As previously announced, a total of 19 patients were enrolled in the multi-center, proof-of-concept study, with seven patients enrolled in the third cohort.
  • The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG.

Akari Therapeutics Announces New Data with Nomacopan from its Surface of the Eye Program

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星期一, 十月 25, 2021
Lung, University College London, T helper cell, Dexamethasone, Inflammation, Thrombotic microangiopathy, Failure, UCL, Leukotriene, Drug development, European Medicines Agency, IL-9, UCL Institute of Ophthalmology, Pathology, C5a, EMA, Security (finance), U.S. Securities and Exchange Commission, Patient, Private Securities Litigation Reform Act, FDA, LTB4, Food, SEC, Eye, Risk, University college, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Annual report, Moorfields Eye Hospital, BP, TMA, Steroid, Leukotriene B4, VKC, Biomarker, COVID-19, Program, Vernal keratoconjunctivitis, Nasdaq, MMP, Therapy, Institute, Intellectual property, GLOBE, AKC, HIV disease progression rates, Seasonal adjustment, Pharmaceutical industry, Vaccine, Medical device

The article in Allergy summarizes a large body of work undertaken with University College of London and Moorfields Eye Hospital.

Key Points: 
  • The article in Allergy summarizes a large body of work undertaken with University College of London and Moorfields Eye Hospital.
  • MMP shares a similar pathology with bullous pemphigoid where Akari has initiated a Phase III study with nomacopan.
  • Clive Richardson, Chief Executive Officer of Akari, commented, The new surface of the eye data is an important step forward in our program and highlights the potential benefits of nomacopans differentiated bi-specific mode of action.
  • Taken together with prior data this collectively points to the more severe form of these diseases as important clinical targets for nomacopan within the $6bn+ surface of the eye market.

InflaRx Awarded up to EUR 43.7 Million (~USD 50.7 Million) Grant by German Government to Advance the Development of Vilobelimab for Treatment of Severe COVID-19

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星期二, 十月 19, 2021
German Federal Archives, Cabinet of Germany, CFO, Technology, COVID-19, Complement, EUR, Autoimmunity, C5a, Disease, Federation, Education, Nasdaq, Jean-Louis Vincent, Phase, GLOBE, Patient, Moisture sensitivity level, Plasma protein binding, Therapy, Inflammation, Company, Pharmaceutical industry

The grant was awarded as part of a government initiative, which the German Federal Government announced earlier this year, to accelerate the development of promising therapeutic options for the treatment of COVID-19 in patients at all stages of disease.

Key Points: 
  • The grant was awarded as part of a government initiative, which the German Federal Government announced earlier this year, to accelerate the development of promising therapeutic options for the treatment of COVID-19 in patients at all stages of disease.
  • We are pleased to receive this significant grant from the German Federal Government, which has recognized the need to invest in the late-stage development of new and promising therapies to treat patients with COVID-19.
  • The purpose of the grant is to advance clinical development activities in COVID-19 and to secure manufacturing capacity for vilobelimab in Germany.
  • The initial tranche amounts to EUR 25.8 million (approximately USD 29.9 million) and is structured as reimbursement of 80% of certain pre-specified expenses related to the clinical development and manufacturing of vilobelimab.

InflaRx Completes Enrollment of Vilobelimab Phase III Study in Severe COVID-19

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星期二, 十月 12, 2021
Patient, Kidney, Autoimmunity, Database, ANCA, Death, Phase, COVID-19, Jean-Louis Vincent, Moisture sensitivity level, End organ damage, Standard of care, Blood, GLOBE, Mortality, Complement, Anti-neutrophil cytoplasmic antibody, Inflammation, C5a, Squamous cell carcinoma, Hidradenitis suppurativa, Pyoderma, Therapy, CSCC, Technology, Nasdaq, Pharmaceutical industry

JENA, Germany, Oct. 12, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients.

Key Points: 
  • JENA, Germany, Oct. 12, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients.
  • The randomized, double-blind and placebo-controlled Phase III part of the Phase II/III study enrolled 369 mechanically ventilated patients with COVID-19 across sites in the EU, South America and other regions.
  • The Phase II part of the study evaluated vilobelimab treatment plus best supportive care compared to best supportive care alone for up to 28 days.
  • The data from the Phase II part of the study have been published in the peer-reviewed journal, The Lancet Rheumatology .

VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan

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星期一, 九月 27, 2021
Biotechnology, General Health, Pharmaceutical, Health, ISIN, Hyperphosphatemia, Cyclophosphamide, Vasculitis, Standard of care, SIX Swiss Exchange, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Population, Death, Nephrology Dialysis Transplantation, Rituximab, Urology, Cell, Microscopic polyangiitis, Nephrology, EMA, Food, Steroid, Failure, European Medicines Agency, Degenerative disease, Receptor (biochemistry), Kidney, MAA, CEO, Granuloma, Disease, Conditional sentence, ANCA, NHI, History, Fresenius Medical Care, Neutrophil, European Commission, C5a, Inflammation, Cancer, Anti-neutrophil cytoplasmic antibody, End organ damage, Marketing, HS, MHLW, Infection, Time, Hidradenitis suppurativa, Kissei, Patient, GPA, Granulomatosis with polyangiitis, Atypical hemolytic uremic syndrome, Vifor Pharma, C5L2, MPA, Pharmaceutical industry, Vifor Pharma Group, Kissei Pharmaceutical Co., Ltd., ChemoCentryx Inc., ANCA-associated vasculitis, TAVNEOS® (avacopan), VIFOR PHARMA GROUP, KISSEI PHARMACEUTICAL CO., LTD., CHEMOCENTRYX INC., ANCA-ASSOCIATED VASCULITIS, TAVNEOS® (AVACOPAN)

ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required.

Key Points: 
  • ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required.
  • There is significant unmet medical need of over 10,000 patients in Japan, and we believe in the potential of TAVNEOS for treating it.
  • TAVNEOS demonstrated superiority over standard of care at week 52 based on Birmingham Vasculitis Activity Score (BVAS).
  • In June 2017, VFMCRP granted Kissei the exclusive right to develop and commercialize TAVNEOS in Japan.

InflaRx to Proceed with Pivotal Development for Vilobelimab in Hidradenitis Suppurativa with New Primary Endpoint

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星期三, 九月 8, 2021

InflaRx had submitted the Type A meeting request to the FDA in July to align on the Phase III HS study design.

Key Points: 
  • InflaRx had submitted the Type A meeting request to the FDA in July to align on the Phase III HS study design.
  • The meeting discussion focused on reaching consensus on the overall study population and the primary endpoint measure.
  • InflaRx is still in active dialogue with the FDA on the final details of the pivotal study design.
  • Once the protocol is approved by the Agency, the Company will provide more details about the study, including the primary endpoint.

InflaRx Announces Positive Data from Second Interim Analysis of Ongoing Phase IIa Open Label Study with Vilobelimab in Pyoderma Gangraenosum

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星期二, 八月 10, 2021
ANCA, Patient, COVID-19, Hypersensitivity, Rheumatoid arthritis, PG, Skin, Moisture sensitivity level, Inflammation, Ulcer, Anti-neutrophil cytoplasmic antibody, Nasdaq, PGA, Safety, Disease, Hidradenitis suppurativa, Squamous cell carcinoma, C5a, Degenerative disease, Arthritis, Inflammatory Bowel Diseases, Prevalence, GLOBE, Technology, Blood, Therapy, Ulcerative colitis, Hematologic disease, Autoimmunity, Multiple myeloma, Complement, Pain, Pyoderma, CSCC, Global Assessment of Functioning, End organ damage, Pharmaceutical industry

JENA, Germany, Aug. 10, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the first 10 evaluable patients in the ongoing Phase IIa open label study with vilobelimab in Pyoderma Gangraenosum (PG).

Key Points: 
  • JENA, Germany, Aug. 10, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the first 10 evaluable patients in the ongoing Phase IIa open label study with vilobelimab in Pyoderma Gangraenosum (PG).
  • As previously announced, enrollment in the proof-of-concept study was completed with 19 patients, with 12 in the first two dose cohorts.
  • The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG.
  • Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases.

Tony Gibney Joins InflaRx Board of Directors

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星期五, 五月 21, 2021
Complement system, C5a, XE-class submarine, Complement component 5a, Mark Tuan, Complement component 5

Mr. Mark K\xc3\xbcbler and Ms. Lina Ma were re-appointed as Non-Executive Directors to the Board of Directors.\n\xe2\x80\x9cWe are excited that Tony is joining the InflaRx board.

Key Points: 
  • Mr. Mark K\xc3\xbcbler and Ms. Lina Ma were re-appointed as Non-Executive Directors to the Board of Directors.\n\xe2\x80\x9cWe are excited that Tony is joining the InflaRx board.
  • \xe2\x80\x9cOur entire team feels fortunate about his commitment and willingness to help InflaRx with its endeavors.
  • We are also very happy to announce the re-election of Lina Ma and Mark K\xc3\xbcbler as board members.
  • Both have contributed to InflaRx for many years and were instrumental in our successful IPO in 2017.\xe2\x80\x9d\nTony Gibney, Board member of InflaRx, said: "I am gratified to have been offered the opportunity to return to the Board of InflaRx, especially at such an important time in the Company\'s evolution as the leader in complement C5a inhibition.

InflaRx Announces Presentation of New C5a and Vilobelimab (IFX-1) Data from Phase IIB SHINE Study at the 2021 Virtual European Hidradenitis Suppurativa Foundation Conference

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星期四, 二月 11, 2021
Medical specialties, Clinical medicine, Medicine, Rare diseases, Acneiform eruptions, Hidradenitis suppurativa, Hidradenitis, C5a, Vasculitis, HS

Data will be presented at the 10th Conference of the European Hidradenitis Suppurativa Foundation e.V.

Key Points: 
  • Data will be presented at the 10th Conference of the European Hidradenitis Suppurativa Foundation e.V.
  • The presentation will highlight the following content:
    C5a levels were significantly elevated in HS patients compared to healthy volunteers.
  • C5a levels from the study were measured using a validated enzyme immunosorbent assay.
  • Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum, cancer and severe COVID-19.