Drugs / SAB-185
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | 2020-08-06 | “We filed the Investigational New Drug (IND) application for SAB-185 in just 98 days from the initiation of the program.” sab.bio ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04469179 | Aug 2020 → Feb 2021 | COVID-19 | SAb Biotherapeutics, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT04468958 | Jul → Dec 2020 | COVID-19 | SAb Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04518410 | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2021-09-24 | SAb Biotherapeutics, Inc. | Results SAB Biotherapeutics Announces SAB-185 Receives Positive DSMB Review and Advances to Phase 3 in NIH-Sponsored ACTIV-2 Trial for Treatment of COVID-19 sab.bio ↗
Both doses of SAB-185 tested in Phase 2 met pre-defined efficacy goal at interim analysis |
| 2021-08-11 | SAb Biotherapeutics, Inc. | Results SAB Biotherapeutics Announces Nonclinical Data Demonstrating SAB-185 Potently Neutralizes Delta and Lambda SARS-CoV-2 Variants sab.bio ↗
today announced the publication of data showing that SAB-185, the company’s therapeutic candidate for the treatment of COVID-19 infections, demonstrates effective and potent neutralization of multiple SARS-CoV-2 variants of concern, including the Delta and Lambda variants. |
| 2021-07-08 | SAb Biotherapeutics, Inc. | Results SAB Biotherapeutics Announces Publication of Preclinical Data Demonstrating SAB-185 Effectively Neutralizes SARS-CoV-2 Variants sab.bio ↗
Findings Published in Human Vaccines & Immunotherapeutics Show SAB-185 Neutralizes Virus Strains Containing Substitutions Present in Variants of Concern |
| 2020-05-28 | SAb Biotherapeutics, Inc. | Results SAB Biotherapeutics Confirms Neutralizing Antibodies To SARS-CoV-2 And Begins Clinical Manufacturing Of Novel COVID-19 Therapeutic Candidate sab.bio ↗ |
All press releases naming this drug 10 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SAB-185 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04468958 ↗ |
| Modality | Protein / enzyme biologic | “purified human immunoglobulin G (hIgG)” NCT04468958 ↗ |
| Route | Intravenous | “administered intravenously” NCT04468958 ↗ |