Drugs / AdCOVID
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | COVID-19 | 2020-12-23 | “today announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug (IND) application for AdCOVID” altimmune.com ↗ |
| Filed | US (FDA) | — | COVID-19 | 2020-11-25 | “today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA)” altimmune.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04679909 | Feb → Dec 2021 | — | Altimmune, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2021-06-29 | Altimmune, Inc. | Results Altimmune Announces Update on AdCOVID™ Phase 1 Clinical Trial altimmune.com ↗
The immunogenicity data demonstrated lower than expected immune responses for each of the immune parameters tested. |
| 2021-05-26 | Altimmune, Inc. | Results Altimmune Demonstrates Strong Neutralization of South African Variant in Preclinical Study of Intranasal AdCOVID™ altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced new results from a preclinical study demonstrating the ability of its AdCOVID vaccine candidate to neutralize the rapidly emerging SARS-CoV-2 B.1.351 variant of concern that originated in South Africa. |
| 2021-05-10 | Altimmune, Inc. | Results Altimmune Announces New Preclinical Data for AdCOVID™ Demonstrating Sterilizing Immunity After a Single Intranasal Dose altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced positive results from a preclinical study of AdCOVID in a SARS-CoV-2 challenge model of infection. |
| 2021-03-15 | Altimmune, Inc. | Results AdCOVID™, Altimmune’s Single Dose, Intranasal COVID-19 Vaccine Candidate, Prevents SARS-CoV-2-induced Disease and Blocks Viral Replication in Preclinical Studies of SARS-CoV-2 Infection altimmune.com ↗
The data, which were obtained in the K18-hACE2 transgenic mouse model, showed that a single intranasal dose of AdCOVID provided 100% protection against a lethal challenge from the SARS-CoV-2 virus. |
| 2021-02-17 | Altimmune, Inc. | Regulatory Altimmune Announces FDA Clearance of AdCOVID™ IND Application altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 1 clinical trial of AdCOVID, a novel, single-dose, intranasal COVID-19 vaccine candidate. |
| 2020-12-23 | Altimmune, Inc. | Regulatory Altimmune Provides an Update on its Investigational New Drug Application for a Phase 1 AdCOVID™ Clinical Trial altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug (IND) application for AdCOVID, a single-dose intranasal COVID-19 vaccine candidate. |
| 2020-11-25 | Altimmune, Inc. | Regulatory Altimmune Announces Submission of Investigational New Drug Application for AdCOVID™ a Single-dose Intranasal COVID-19 Vaccine; On Track to Commence Phase 1 Clinical Study in December altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company advancing proprietary intranasal vaccines and peptide therapeutics, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. |
| 2020-10-12 | Altimmune, Inc. | Results Altimmune and UAB Announce Publication of Compelling Pre-clinical Data for AdCOVID™ Intranasal COVID-19 Vaccine Candidate altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today pre-published a comprehensive preclinical evaluation of its single-dose, intranasal COVID-19 vaccine candidate, AdCOVID, in a manuscript entitled, “Single-dose intranasal administration of AdCOVID elicits systemic and mucosal immunity against SARS-CoV-2 in mice.” |
| 2020-08-25 | Altimmune, Inc. | Results Altimmune and the University of Alabama at Birmingham Announce Potent Respiratory Mucosal T Cell Responses in Preclinical Study of Single-Dose Intranasal COVID-19 Vaccine Candidate, AdCOVID™ altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced additional positive results from the preclinical studies of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID. |
| 2020-07-13 | Altimmune, Inc. | Results Altimmune and the University of Alabama at Birmingham (UAB) Announce Positive Preclinical Results for Intranasal COVID-19 Vaccine Candidate, AdCOVID™ altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced positive results from the preclinical studies of its intranasal COVID-19 vaccine candidate, AdCOVID. |
All press releases naming this drug 17 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AdCOVID | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04679909 ↗ |
| Route | Intranasal | “Administered intranasally” NCT04679909 ↗ |