Drugs / XAV-19
last change Jul 2024 re-read 3 minutes ago

XAV-19

Protein / enzyme biologic

Developed for
COVID-19 · Orthocoronavirinae infectious disease
Investigated by
Xenothera SAS · BPIfrance · Nantes University Hospital

Trials 2

202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial · 1 missed
Phase 2 NCT04453384 Sep 2020 → May 2021 Orthocoronavirinae infectious disease Nantes University Hospital Completed Missed primary
Phase 2/31 trial · 1 missed
Phase 2/3 NCT04928430 Apr 2021 → Nov 2022 COVID-19 Xenothera SAS Terminated Missed primary Stop: Enrollment

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2024-07-09 Xenothera SAS Results XENOTHERA publishes the clinical efficacy of XAV-19, its anti-COVID antibody, in Frontiers in Immunology xenothera.com ↗
This new publication ( Poulakou et al. Front. Immunol., 2024 ) demonstrates the efficacy of XAV-19 in the recovery of patients suffering from moderate COVID.
2023-10-25 Xenothera SAS Results [Press Release] French biotech announces its therapeutic potential for oxygen-free patients xenothera.com ↗
Les essais cliniques français et européen de phase II et II /III (Polycor et Euroxav) évaluant l’intérêt thérapeutique du traitement anti -Covid XAV-19 développé par la biotech nantaise XENOTHERA livrent leurs conclusions.
2023-04-21 Xenothera SAS Results [Press Release] XAV-19, the anti-SARS-CoV-2 GH-pAb of XENOTHERA best-in-class against all variants including BQ. 1.1 xenothera.com ↗
XAV-19 exhibits a strong neutralization activity against all omicron variants, including BQ.1.1, the main variant of SARS-CoV-2 in circulation to date.
2022-12-21 Xenothera SAS Results [Press Release] XAV-19: end of EUROXAV clinical trial and positive trends for the XENOTHERA antibody. xenothera.com ↗
La biotech annonce aujourd’hui mettre fin à son essai clinique européen et communique les premiers éléments d’efficacité.
2022-12-21 Xenothera SAS Results [Press Alert] XENOTHERA announces the efficacy of its XAV-19 antibody against the BQ.1.1variant. xenothera.com ↗
Le XAV-19, anticorps polyclonal anti-Covid protecteur naturel , est efficace contre BQ.1.1, comme envers les autres variants ou le virus d’origine.
2021-07-18 Xenothera SAS Regulatory [Press Release] Accelarated Scientific Advise from European Medicines Adgency EMA for XAV19 Market Authorisation xenothera.com ↗
Le Comité des médicaments à usage humain (CHMP) de l’EMA a validé l’approche présentée par XENOTHERA, en particulier la qualité du médicament, la validité des analyses précliniques et toxicologiques, et l’approche générale du plan de développement clinique du XAV-19.
2021-04-07 Xenothera SAS Results [Press Release] Effectiveness of XAV19 against SARS-CoV-2 variants xenothera.com ↗
La biotech nantaise XENOTHERA annonce ce matin l’efficacité anti-variants du XAV-19, son traitement anti-Covid-19, un anticorps polyclonal dirigé contre le virus SARS-CoV- 2.
2021-01-28 Xenothera SAS Results [Press Alert] Omicron Variant : positive results for XENOTHERA’s XAV-19 antibody xenothera.com ↗
The Nantes-based biotech company XENOTHERA has announced the first in vitro efficacy results for its polyclonal anti-Covid antibody against the Omicron variant.
2021-01-03 Xenothera SAS Regulatory [Press Alert] New step for XENOTHERA and the Nantes University Hospital xenothera.com ↗
The Nantes-based biotech XENOTHERA and the Nantes University Hospital announced today the authorization by the ANSM to start phase 2b of the French clinical trial POLYCOR, which tests the therapeutic efficacy of XAV-19, the anti-Covid treatment -19 developed by XENOTHERA.
2020-11-12 Xenothera SAS Results [Press Release] XAV19 : validation of the first dose of anti-Covid treatment of XENOTHERA xenothera.com ↗
L’essai clinique POLYCOR poursuit sa route après la validation par le comité indépendant (DSMB) de la tolérance de la première dose de XAV-19 chez les 10 premiers patients.
2020-08-12 Xenothera SAS Regulatory [Press Alert] XENOTHERA obtains authorization from ANSM to start the clinical trial of XAV19, its anti Covid treatment xenothera.com ↗
XENOTHERA, société de biotechnologie nantaise, annonce avoir reçu ce vendredi 7 août 2020 l'autorisation officielle de l'Agence nationale de sécurité du médicament et des produits de santé (ANSM) de démarrer l’essai clinique de phase 2 à usage humain de son traitement XAV-19.
2020-05-08 Xenothera SAS Regulatory [Newsletter -2] NEWS /INFOS xenothera.com ↗
L’actualité cette semaine, c’est un retour formel de l’ANSM sur le projet du XAV-19.

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as XAV-19 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04453384 ↗
1

NCT04928430 ↗

Action Inhibit “inhibiting infection of ACE-2 positive human cells with SARS-CoV-2” NCT04453384 ↗
Modality Protein / enzyme biologic “XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb)” NCT04453384 ↗
Route Intravenous “which can be administered as intravenous treatment” NCT04453384 ↗