C5a

InflaRx Announces Positive Topline Results from the Multiple Ascending Dose (MAD) Phase I Study with C5aR Inhibitor INF904

Retrieved on: 
Thursday, January 4, 2024
Receptor (biochemistry), EST, Conference, C5a, Aes, Biotechnology, BID, Cmax, MD, Conference call, PD, Food, SAD, Patient, Safety, Therapy, Atomic mass, Pharmaceutical industry

INF904 was well tolerated and there were no adverse safety events of concern after repeated dosing in participants over the entire tested dose range.

Key Points: 
  • INF904 was well tolerated and there were no adverse safety events of concern after repeated dosing in participants over the entire tested dose range.
  • “We are very pleased that the MAD part of the Phase I study exceeded the already compelling results from the SAD part of the study.
  • InflaRx currently plans to initiate a short-term dosing Phase II study towards the end of 2024, followed by a longer-term dosing Phase II study in 2025.
  • A replay will be available on the InflaRx website in the Investors – Events & Presentations section after the live conference call has concluded.

ULTOMIRIS: A Complement Inhibitor for Treating Adult Patients with PNH - Drug Insights and Market Forecasts to 2032 with Focus on 7MM - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Research, Immune system, Hematology, Clinical trial, PNH, Patient, Neurology, SWOT, EU4, Hemolysis, Nephrology, Complement component 5, C5a, Inflammation, Risk management, Vaccine, Pharmaceutical industry

This report provides comprehensive insights about ULTOMIRIS for paroxysmal nocturnal hemoglobinuria (PNH) in the seven major markets.

Key Points: 
  • This report provides comprehensive insights about ULTOMIRIS for paroxysmal nocturnal hemoglobinuria (PNH) in the seven major markets.
  • The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities.
  • Further, it also consists of future market assessments inclusive of the ULTOMIRIS market forecast analysis for PNH in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in PNH.
  • ULTOMIRIS is a complement inhibitor for treating adult patients with PNH.

InflaRx Announces Positive Topline Results from the Single Ascending Dose (SAD) Phase I Study with C5aR Inhibitor INF904

Retrieved on: 
Monday, September 11, 2023
PK, Integrin alpha M, PD, Therapy, C5a, Neutrophil, Conference call, Receptor (biochemistry), Biotechnology, Inflammation, COVID-19, Aes, SAD, Cmax, EDT, Plasma, Patient, Hidradenitis suppurativa, MAD, Septic, Downregulation and upregulation, Conference, Fasting, Safety, Disease, Pharmaceutical industry, Cryptocurrency

The main objectives were to assess safety and tolerability of single ascending doses under fasting conditions.

Key Points: 
  • The main objectives were to assess safety and tolerability of single ascending doses under fasting conditions.
  • We look forward to seeing the results from the MAD part of the study and advancing INF904 in development,” commented Renfeng Guo, M.D., Chief Scientific Officer and Founder of InflaRx.
  • Analysis of INF904 PK in subject plasma samples revealed sustained exposure to INF904 with six hours to maximum concentration (tmax).
  • INF904 plasma levels were dose proportional for systemic exposure (AUClast) and nearly dose proportional for maximum concentration (Cmax) over the dose range used in the study.

InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA)

Retrieved on: 
Wednesday, August 30, 2023
Biologics license application, IMV, Therapy, C5a, Senior, The Lancet, SARS-CoV-2, Biotechnology, Extracorporeal membrane oxygenation, European Medicines Agency, COVID-19, Survival, ECMO, European Directive on Traditional Herbal Medicinal Products, EDT, Marketing, Intensive care medicine, EMA, Food and Drug Administration, Emergency Use Authorization, Patient, European, Webcast, Mortality, Septic, MAA, Regulatory affairs, FDA, BLA, Food, CHMP, Pharmaceutical industry, EU

This means that the application is now under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure, which applies to all 27 member states of the European Union (EU).

Key Points: 
  • This means that the application is now under regulatory review by the European Committee for Medicinal Products for Human Use (CHMP) under the centralized procedure, which applies to all 27 member states of the European Union (EU).
  • InflaRx submitted the MAA to EMA in July 2023 following interactions with the rapporteur and co-rapporteur teams of the CHMP.
  • The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set.
  • “We are pleased that EMA has accepted our MAA submission and that it is now under review.

NovelMed Phase I Clinical Trial Shows Inhibition of the Alternative Pathway and Preservation of the Classical Pathway – A Long-Acting Anti-Properdin Monoclonal Antibody NM3086 for PNH Patients

Retrieved on: 
Monday, June 5, 2023
C3b, PD, C5a, Serum, Receptor (biochemistry), IVH, Pathology, CP, Pharmacokinetics, AP, Intravascular hemolysis, EVH, C3a, Disorder, Trial of the century, MAC, Clinical trial, Paroxysmal nocturnal hemoglobinuria, Patient, Anemia, PNH, Complement factor B, FDA, Therapy, ADA, Safety, Vaccine, News, Hydraulic machinery, Pharmaceutical industry

Total AP inhibition was achieved through all cohorts and the duration of alternative pathway (AP) inhibition occurred in a dose-dependent manner.

Key Points: 
  • Total AP inhibition was achieved through all cohorts and the duration of alternative pathway (AP) inhibition occurred in a dose-dependent manner.
  • Correspondingly, the classical pathway (CP) remained unaffected, suggesting that NM3086 selectively blocks the AP while maintaining the host defense.
  • The duration of AP-C3b inhibition followed the AP inhibition profile very closely in a dose dependent manner.
  • CLEVELAND, June 05, 2023 (GLOBE NEWSWIRE) -- NovelMed Therapeutics, Inc. announced today topline results from First-in-Human Phase I clinical trial of its complement blocker monoclonal anti-Properdin antibody, known as NM3086.

WuXi Biologics Announces Manufacturing Partnership with InflaRx to Advance Gohibic for the Treatment of Certain Critically Ill COVID-19 patients

Retrieved on: 
Tuesday, May 16, 2023
EUA, Partnership, IMV, Therapy, C5a, Extracorporeal membrane oxygenation, COVID-19, ECMO, DS, Development, Contract research organization, Patient, CGMP, WuXi Biologics, FDA, Wuxi, Fine chemical, Pharmaceutical industry

InflaRx received emergency use authorization (EUA) from the FDA for Gohibic (vilobelimab) for the treatment of certain critically ill COVID-19 patients in April 2023.

Key Points: 
  • InflaRx received emergency use authorization (EUA) from the FDA for Gohibic (vilobelimab) for the treatment of certain critically ill COVID-19 patients in April 2023.
  • WuXi Biologics will leverage its global manufacturing network and dual-sourcing strategy to support InflaRx in making Gohibic available to patients as quickly as possible.
  • WUXI, China, May 16, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced the manufacturing partnership with InflaRx for its COVID-19 treatment Gohibic (vilobelimab).
  • Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are proud of this manufacturing partnership with InflaRx for Gohibic.

WuXi Biologics Announces Manufacturing Partnership with InflaRx to Advance Gohibic for the Treatment of Certain Critically Ill COVID-19 patients

Retrieved on: 
Tuesday, May 16, 2023
EUA, Partnership, IMV, Therapy, C5a, Extracorporeal membrane oxygenation, COVID-19, ECMO, DS, Development, Contract research organization, Patient, CGMP, WuXi Biologics, FDA, Wuxi, Fine chemical, Pharmaceutical industry

InflaRx received emergency use authorization (EUA) from the FDA for Gohibic (vilobelimab) for the treatment of certain critically ill COVID-19 patients in April 2023.

Key Points: 
  • InflaRx received emergency use authorization (EUA) from the FDA for Gohibic (vilobelimab) for the treatment of certain critically ill COVID-19 patients in April 2023.
  • WuXi Biologics will leverage its global manufacturing network and dual-sourcing strategy to support InflaRx in making Gohibic available to patients as quickly as possible.
  • WUXI, China, May 16, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced the manufacturing partnership with InflaRx for its COVID-19 treatment Gohibic (vilobelimab).
  • Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are proud of this manufacturing partnership with InflaRx for Gohibic.

InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients

Retrieved on: 
Tuesday, April 4, 2023
EUA, Vaccine, Sepsis, IMV, Therapy, C5a, The Lancet, Conference call, Extracorporeal membrane oxygenation, European Medicines Agency, COVID-19, Survival, ECMO, European Directive on Traditional Herbal Medicinal Products, EDT, Intensive care medicine, Dexamethasone, EMA, Hospital, Emergency Use Authorization, Patient, Standard of care, CEST, Mortality, Marketing Authorisation Application, Pyoderma, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, News, Conference, Food, CHMP, Pharmaceutical industry, Perfume

PANAMO is one of the largest 1:1 randomized, double-blind placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units.

Key Points: 
  • PANAMO is one of the largest 1:1 randomized, double-blind placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units.
  • A total of 369 patients were randomly assigned to the vilobelimab treatment group (six 800-mg infusions) or the placebo group.
  • InflaRx continues discussions with FDA related to submission of a BLA for full approval of Gohibic in this COVID-19 indication.
  • The Company is assessing all options for supplying drug to hospitals to enable the treatment of patients.

Devic's Syndrome Treatment Global Market Report 2022: Soliris (Eculizumab) to Foster Growth in the Sector - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 22, 2023
Health, Pharmaceutical, Complement component 5, Neuron, Syndrome, C5a, Spinal cord, Neuromyelitis optica spectrum disorder, National Multiple Sclerosis Society, MedImmune, Chugai Pharmaceutical Co., Woman, NMOSD, CNS, Plasma protein binding, Protein, Patient, Immune system, Optic nerve, Alexion, Diagnosis, Rare, Death, Autoantibody, Pharmaceutical industry, Eculizumab

Soliris works by specifically preventing activation of particular proteins in the complement system (C5a and C5b), which play a role in the treatment of Devic s syndrome.

Key Points: 
  • Soliris works by specifically preventing activation of particular proteins in the complement system (C5a and C5b), which play a role in the treatment of Devic s syndrome.
  • Patients suffering with Devic's syndrome possess AQP4 antibody-positive, the body s immune system can turn against itself to produce autoantibodies against AQP4.
  • There are three promising molecules in Devic s syndrome treatment pipeline such as Satralizumab - Phase 3 (Hoffmann-La Roche/ Chugai Pharmaceutical), MEDI-551- Phase 2/3 (MedImmune LLC), and RC18 - Phase 3 (RemeGen, Ltd.).
  • According to National Multiple Sclerosis Society, there are around 4,000 people suffering with Devic's syndrome in the United States with majority of women population.

InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients

Retrieved on: 
Thursday, January 5, 2023
Neutrophil, PGA, PG, OD, European Medicines Agency, COVID-19, Jean-Louis Vincent, C5a, Patient, Plasma, EUA, Particle-size distribution, Ulcer, FDA, Therapy, Dentistry, Observation, EMA, Nightclub, Pharmaceutical industry, Dermatology

The planned Phase III study is designed to enroll patients in the US, Europe and selected countries in other regions.

Key Points: 
  • The planned Phase III study is designed to enroll patients in the US, Europe and selected countries in other regions.
  • Treatment will be discontinued for patients whose disease progresses or fails to improve at defined time points during the study.
  • In September 2022, the Company submitted its application for emergency use authorization (EUA) of vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients with the FDA.
  • The Company will continue to interact closely with the FDA and will provide a timely update when appropriate.