XAV-19
/ LFB SA, Xenothera
- LARVOL DELTA
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May 02, 2024
Anti-SARS-CoV-2 glyco-humanized polyclonal antibody XAV-19: phase II/III randomized placebo-controlled trial shows acceleration to recovery for mild to moderate patients with COVID-19.
(PubMed, Front Immunol)
- P2/3 | "Altogether, these data support a possible therapeutic interest for patients with mild to moderate COVID-19 requiring anti-SARS-CoV-2 neutralizing antibodies. https://clinicaltrials.gov/, identifier NCT04928430; https://www.clinicaltrialsregister.eu/about.html (EudraCT), identifier 2020-005979-12."
Clinical • Journal • P2 data • P2/3 data • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
November 09, 2023
Effect of Swine Glyco-humanized Polyclonal Neutralizing Antibody on Survival and Respiratory Failure in Patients Hospitalized With Severe COVID-19: A Randomized, Placebo-Controlled Trial.
(PubMed, Open Forum Infect Dis)
- "In the safety population, adverse events were reported in 75.4% of 199 patients in the XAV-19 group and in 76.3% of 190 patients in the placebo group through D29. Among patients hospitalized with COVID-19 requiring low-flow oxygen therapy, treatment with a single intravenous dose of XAV-19, compared with placebo, did not show a significant difference in terms of disease progression at day 15."
Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
March 08, 2023
XAV-19, un anti-variant de Sars-CoV-2, BQ.1.1 compris.
(PubMed, Rev Francoph Lab)
- No abstract available
Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
January 23, 2023
EUROXAV: Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19
(clinicaltrials.gov)
- P2/3 | N=290 | Terminated | Sponsor: Xenothera SAS | N=722 ➔ 290 | Trial completion date: Apr 2022 ➔ Nov 2022 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2022 ➔ Nov 2022; Lack of recruitment
Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease
March 25, 2022
POLYCOR: Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia
(clinicaltrials.gov)
- P2 | N=416 | Completed | Sponsor: Nantes University Hospital | Active, not recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Aug 2021 | Trial primary completion date: Dec 2021 ➔ May 2021
Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia
December 07, 2021
XAV-19, a Swine Glyco-Humanized Polyclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Domain, Targets Multiple Epitopes and Broadly Neutralizes Variants.
(PubMed, Front Immunol)
- P2, P2/3 | "XAV-19 is currently evaluated in patients hospitalized for COVID-19-induced moderate pneumonia in phase 2a-2b (NCT04453384) where safety was already demonstrated and in an ongoing 2/3 trial (NCT04928430) to evaluate the efficacy and safety of XAV-19 in patients with moderate-to-severe COVID-19. Owing to its polyclonal nature and its glyco-humanization, XAV-19 may provide a novel safe and effective therapeutic tool to mitigate the severity of coronavirus disease 2019 (COVID-19) including the different variants of concern identified so far."
Journal • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases
November 29, 2021
EUROXAV: Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19
(clinicaltrials.gov)
- P2/3; N=722; Recruiting; Sponsor: Xenothera SAS; Trial completion date: Aug 2021 ➔ Apr 2022; Trial primary completion date: Aug 2021 ➔ Apr 2022
Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease
November 15, 2021
"XAV-19 médicament fantôme."
(@peinture_huile)
September 25, 2021
Antibody and cellular therapies for treatment of covid-19: a living systematic review and network meta-analysis.
(PubMed, BMJ)
- "In patients with non-severe covid-19, casirivimab-imdevimab probably reduces hospitalisation; bamlanivimab-etesevimab, bamlanivimab, and sotrovimab may reduce hospitalisation. Convalescent plasma, IVIg, and other antibody and cellular interventions may not confer any meaningful benefit."
Journal • Retrospective data • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases
July 21, 2021
POLYCOR: Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia
(clinicaltrials.gov)
- P2; N=416; Active, not recruiting; Sponsor: Nantes University Hospital; Recruiting ➔ Active, not recruiting; Trial primary completion date: Dec 2020 ➔ Dec 2021
Clinical • Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia
June 29, 2021
Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study.
(PubMed, Antimicrob Agents Chemother)
- P2 | " Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384."
Clinical • Journal • P2a data • PK/PD data • Immunology • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases
June 16, 2021
Efficacy and Safety of XAV-19 for the Treatment of Moderate-to-severe COVID-19
(clinicaltrials.gov)
- P2/3; N=722; Recruiting; Sponsor: Xenothera SAS
New P2/3 trial • Infectious Disease • Novel Coronavirus Disease
May 03, 2021
XENOTHERA And Its Partner Excelya Announce the Recruitment of the First Patient in The EUROXAV Clinical Trial of its COVID Treatment XAV-19
(Businesswire)
- "The biotech company XENOTHERA has begun the European clinical trial of its anti-COVID treatment, XAV-19. The Nantes laboratory is the sponsor of the trial, called EUROXAV, which will be carried out by Excelya...EUROXAV is a multi-center, double-blind phase III trial that will recruit 722 patients with moderate COVID, hospitalized or monitored remotely. The trial will take place in Greece, Bulgaria, Romania, Spain and Turkey. The first patient in the trial was recruited on April 28th at Professor Poulakou's center (GR04) in Greece. The cohort of 722 patients will complement the 398 patients in the POLYCOR trial, a trial carried out in 35 French hospitals under the sponsorship of the Nantes University Hospital, which has just closed its recruitment phase with results expected Summer 2021."
Enrollment status • P2 data • Trial status • Infectious Disease • Novel Coronavirus Disease
March 23, 2021
Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial.
(PubMed, Trials)
- P=N/A, P2 | "This study will determine the clinical benefits of XAV-19 when administered to patients with SARS-CoV-2-induced moderate pneumonia. As a prerequisite, a first step of the study will define the safety and the dose of XAV-19 to be used. Such treatment might become a new therapeutic option to provide an effective treatment for COVID-19 patients (possibly in combination with anti-viral and immunotherapies). Further studies could later evaluate such passive immunotherapy as a potential post-exposure prophylaxis."
Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases
March 05, 2021
Efficacy and safety of XAV-19 for the treatment of moderate to severe COVID-19 Αποτελεσματικότητα και ασφάλεια του XAV-19 για τη θεραπεία μέτριας έως βαριάς μορφής COVID-19
(clinicaltrialsregister.eu)
- P2/3; N=722; Ongoing; Sponsor: XENOTHERA
Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease
February 13, 2021
High neutralizing potency of swine glyco-humanized polyclonal antibodies against SARS-CoV-2.
(PubMed, Eur J Immunol)
- "The IgG fraction purified and formulated following clinical Good Manufacturing Practices, named XAV-19, neutralized Spike/angiotensin converting enzyme-2 (ACE-2) interaction at a concentration < 1 μg/mL and inhibited infection of human cells by SARS-CoV-2 in cytopathic assays...We also found that pig GH-pAb Fc domains fail to interact with human Fc receptors, thereby avoiding macrophage dependent exacerbated inflammatory responses and a possible antibody-dependent enhancement (ADE). These data and the accumulating safety advantages of using GH-pAbs in humans warrant clinical assessment of XAV-19 against COVID-19."
Journal • Allergy • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases
September 16, 2020
POLYCOR: Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia
(clinicaltrials.gov)
- P2; N=368; Recruiting; Sponsor: Nantes University Hospital; Not yet recruiting ➔ Recruiting; Trial completion date: Sep 2021 ➔ Dec 2021
Clinical • Enrollment open • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases
August 08, 2020
A study to evaluate the safety and efficacy of XAV-19 in patients with COVID-19 induced moderate pneumonia Etude pour évaluer la sécurité et l'efficacité du XAV-19 chez des patients COVID-19 atteints de pneumonie modérée à COVID-19
(clinicaltrialsregister.eu)
- P1/2; N=368; Ongoing; Sponsor: Nantes CHU
Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases
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