Drugs / PTX-COVID19-B
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT04765436 | Jan 2021 → Mar 2022 | — | Providence Therapeutics Holdings Inc. | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT05175742 | Aug 2021 → Mar 2023 | — | Providence Therapeutics Holdings Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05534035 | Feb → Apr 2023 | COVID-19 | Everest Medicines (Singapore) Pte. Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05534048 | Feb → Jul 2023 | COVID-19 | Everest Medicines (Singapore) Pte. Ltd. | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-02-04 | Providence Therapeutics Holdings Inc. | Regulatory Providence Therapeutics Submits Clinical Trial Application (CTA) to Health Canada for its mRNA COVID Vaccine providencetherapeutics.com ↗
Providence Therapeutics confirmed today that a Clinical Trial Application (CTA) was submitted to Health Canada, December 3, for the mRNA COVID vaccine, PTX-COVID19-B . |
| 2026-02-04 | Providence Therapeutics Holdings Inc. | Regulatory Providence Therapeutics COVID-19 Vaccine Receives Health Canada Authorization to Begin Clinical Trials providencetherapeutics.com ↗
Providence Therapeutics today announced that Health Canada has provided a Notice of Authorization for its Clinical Trial Application. |
| 2022-11-28 | Providence Therapeutics Holdings Inc. | Results Providence Therapeutics Presents Phase 2 Data on its mRNA COVID-19 Vaccine Candidate PTX-COVID19-B at the 2022 World Vaccine & Immunotherapy Congress providencetherapeutics.com ↗
Phase 2 data have shown that PTX-COVID19-B is comparable to Pfizer and BioNTech’s widely used COVID-19 mRNA vaccine with respect to neutralizing antibody concentration at two weeks following the second of two doses. |
| 2022-10-19 | Providence Therapeutics Holdings Inc. | Results Providence Announces Positive Top-Line Data from Phase 2 Primary Immunization Trial of its mRNA Vaccine Candidate PTX-COVID19-B in Adults providencetherapeutics.com ↗
PTX-COVID19-B demonstrated non-inferiority compared to Comirnaty®, Pfizer’s and BioNTech’s U.S. FDA-approved mRNA vaccine, with respect to the geometric mean titer (GMT) ratio of neutralizing antibodies observed two weeks after the second of two intramuscular injections. |
| 2021-09-13 | Providence Therapeutics Holdings Inc. | Results Providence Therapeutics Reports PTX-COVID19-B, its mRNA Vaccine for COVID-19, Neutralizes SARS-CoV-2 and Variants of Concern, Including Delta providencetherapeutics.com ↗
Sera from all subjects dosed with PTX-COVID19-B demonstrated neutralizing activity by day 28 after only a single dose while none of the subjects dosed with a placebo generated neutralizing antibodies. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PTX-COVID19-B | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05534048 ↗ |
| Modality | Messenger RNA (mRNA) | “Therefore, a low-cost mRNA vaccine, PTX-COVID19-B, was produced and evaluated in a Phase 1 trial.” PMID 37236995 ↗ May 2023 |
| Route | Intramuscular | “Participants, 45 healthy adults 18 to 64 years of age, will receive 1 intramuscular (IM) injection of PTX-COVID19-B vaccine in doses of 16 μg, 40 μg and 100 μg on Day 1,...” NCT04765436 ↗ |