Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FP-02.2 Vaccine · 1 trial · 1 indication
Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,
Incidence of local injection site reactions occurring up to 7 days after each injection
| Arm | Type | Description |
|---|---|---|
| FP-02.2 Low Dose | EXPERIMENTAL | A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57. |
| FP-02.2 High Dose | EXPERIMENTAL | A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57. |
| FP-02.2 Low Dose with IC31® Adjuvant | EXPERIMENTAL | A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57. |
| FP-02.2 High Dose with IC31® Adjuvant | EXPERIMENTAL | A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered by IM injection on Days 1, 29, and 57. |
| IC31® Adjuvant | EXPERIMENTAL | IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57. |
| Name | Type | Description |
|---|---|---|
| FP-02.2 Vaccine | BIOLOGICAL | Synthetic Peptide Hepatitis B Vaccine |
| Placebo | OTHER | Placebo |
| IC31® Adjuvant | OTHER | IC31® Adjuvant |
Inclusion Criteria: 1. Male and female subjects aged 18-65 years. 2. Diagnosed with chronic hepatitis B defined as HBsAg positive for at least 24 months. 3. Subject has received entecavir or tenofovir for at least 2 years with a stable dose for at least 6 months prior to screening. 4. HBeAg negativ...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
FP-02.2 Vaccine is an investigational vaccine developed by Altimmune, Inc. for chronic hepatitis B. It is designed to stimulate an immune response against the hepatitis B virus. The vaccine has been evaluated in a Phase 1 clinical trial and is not yet approved for any indication.
FP-02.2 Vaccine is being developed for the treatment of chronic hepatitis B, a viral infection of the liver. It is intended to induce an immune response that may help control the infection. The vaccine is investigational and has not been approved for use.
FP-02.2 Vaccine is developed by Altimmune, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol ALT. Altimmune is responsible for the research and clinical development of the vaccine.
FP-02.2 Vaccine is in Phase 1 clinical development. A Phase 1 trial has been completed, and the vaccine remains investigational. It has not been approved by the FDA or any other regulatory agency for commercial use.
FP-02.2 Vaccine has been studied in a Phase 1 clinical trial, NCT02496897, titled Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B. The trial enrolled 61 participants, was randomized, double-blind, and placebo-controlled, and was conducted in South Korea and the United Kingdom. It is now completed.