Drugs / HFB30132A
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | 2020-08-26 | “announced today the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA)” hifibio.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05275660 | May 2021 → Feb 2022 | — | HiFiBiO Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04590430 | Oct 2020 → Jul 2021 | — | HiFiBiO Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2021-09-23 | HiFiBiO Therapeutics | Results HiFiBiO Therapeutics Contributes to CoVIC-Led Science Publication on SARS-CoV-2 Spike Antibodies Effective Against Variants of Concern hifibio.com ↗
In a recently completed clinical trial in healthy volunteers (NCT04590430), Enuzovimab was well tolerated and non-immunogenic at all doses tested, exhibited extended half-life in the blood, and distributed to the respiratory mucosa. |
| 2021-05-11 | HiFiBiO Therapeutics | Results HiFiBiO Therapeutics Announces Publication in Nature Communications on its SARS-CoV-2 Neutralizing Monoclonal Antibody hifibio.com ↗
today announced a publication in Nature Communications with its collaborators at Xinhua Hospital and Nankai University on the preclinical data for its SARS-CoV-2 neutralizing monoclonal antibody, HFB30132A [1] (P4A1-2A in the manuscript). |
| 2020-08-26 | HiFiBiO Therapeutics | Regulatory HiFiBiO Therapeutics Submits IND Application for Fully Human SARS-CoV-2 Neutralizing Antibody for the Treatment of COVID-19 Patients hifibio.com ↗
HiFiBiO Therapeutics, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, announced today the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a novel SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-09-23 | HiFiBiO Therapeutics | HiFiBiO Therapeutics Contributes to CoVIC-Led Science Publication on SARS-CoV-2 Spike Antibodies Effective Against Variants of Concern hifibio.com ↗ |
| 2021-05-11 | HiFiBiO Therapeutics | HiFiBiO Therapeutics Announces Publication in Nature Communications on its SARS-CoV-2 Neutralizing Monoclonal Antibody hifibio.com ↗ |
| 2020-08-26 | HiFiBiO Therapeutics | HiFiBiO Therapeutics Submits IND Application for Fully Human SARS-CoV-2 Neutralizing Antibody for the Treatment of COVID-19 Patients hifibio.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HFB30132A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04590430 ↗ |
| Action | Inhibit | “neutralizing activity against majority of the virus variants identified so far” PMID 37332355 ↗ May 2023 |
| Modality | Monoclonal antibody | “HFB30132A, a Monoclonal Antibody Directed Against SARS-CoV-2” NCT04590430 ↗ |
| Route | Intravenous | “via intravenous infusions” NCT04590430 ↗ |