Drugs / HepTcell
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04684914 | Dec 2020 → Mar 2024 | chronic hepatitis B virus infection | Altimmune, Inc. | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2024-03-27 | Altimmune, Inc. | Results Altimmune Announces Positive Lean Mass Preservation Data for Pemvidutide and Reports Fourth Quarter and Full Year 2023 Financial Results altimmune.com ↗
The overall response in the trial was deemed to be insufficient to warrant further advancement. |
| 2020-06-22 | Altimmune, Inc. | Regulatory Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. |
| 2019-01-29 | Altimmune, Inc. | Results Altimmune Announces Presentation of HepTcell Phase 1 Results at The International Liver Congress™ in Vienna, Austria altimmune.com ↗
In the two adjuvanted HepTcell arms, T cell responses against HBV markedly increased over baseline compared to placebo. |
| 2018-12-13 | Altimmune, Inc. | Results Altimmune Announces Clinical Program Updates and Plans for Pipeline Expansion altimmune.com ↗
The Company has completed the planned final analysis, that also included individual subject changes from baseline, and are very encouraged to note that the two adjuvanted HepTcell arms had markedly greater increases in T cell |
| 2018-03-27 | Altimmune, Inc. | Results Altimmune Announces Positive Data From Its Phase 2a Study of NasoVAX Intranasal Influenza Vaccine and Provides an Update on Its Phase 1b Study of HepTcell Targeted Immunotherapy in Chronic Hepatitis B Infection altimmune.com ↗
Results from the Phase 1b study of HepTCell in hepatitis B infection showed that HepTcell was well tolerated at all doses tested, while the unblinded T-cell immunogenicity results were inconclusive. |
| 2017-12-21 | Altimmune, Inc. | Results Altimmune Announces Positive Initial Data from Its HepTcell Phase 1 Study altimmune.com ↗
Additionally, the preliminary data showed evidence of dose dependent increases in cellular immune response to HBV antigens. |
All press releases naming this drug 8 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HepTcell | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04684914 ↗ |
| Known as | FP-02.2 | “Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine” NCT04684914 ↗ |
| Modality | Vaccine | “as an Immunotherapeutic Vaccine” NCT04684914 ↗ |
| Route | Intramuscular | “Intramuscular injection” NCT04684914 ↗ |