Overview
XAV-19 is an intravenous antibody-based treatment targeted towards SARS-CoV-2 and other coronaviruses. The therapy concept is based on COVID-19 convalescent plasma. However, rather than using human plasma, XAV-19 is a heterologous swine glyco-humanized polyclonal antibody that targets the spike protein of SARS-CoV-2. The therapy offers three beneficial effects: the ability to neutralize the virus, reduce inflammatory responses, and the absence of aggravating reactions following treatment. Xenothera has partnered with LFB, a pharmaceutical company, to develop XAV-19, and with Nantes University Hospital to test the treatment in patients. As of July, 2020, the company is conducting a Phase 2 randomized clinical trial to define dosing safety and efficacy of XAV-19 (NCT04453384).
Background
XAV-19 is an intravenous antibody-based treatment targeted towards SARS-CoV-2 and other coronaviruses. The therapy concept is based on COVID-19 convalescent plasma. However, rather than using human plasma, XAV-19 is a heterologous swine glyco-humanized polyclonal antibody that targets the spike protein of SARS-CoV-2. The therapy offers three beneficial effects: the ability to neutralize the virus, reduce inflammatory responses, and the absence of aggravating reactions following treatment. Xenothera has partnered with LFB, a pharmaceutical company, to develop XAV-19, and with Nantes University Hospital to test the treatment in patients. As of July, 2020, the company is conducting a Phase 2 randomized clinical trial to define dosing safety and efficacy of XAV-19 (NCT04453384).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/06/16 | Phase 2 | Terminated | |||
2020/07/01 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||