Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMP012 with AS01B adjuvant system · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1: 10 µg FMP012 adjuvanted AS01B | EXPERIMENTAL | FMP012 with AS01B adjuvant system: 10 µg FMP012 antigen reconstituted with 500 µL AS01B adjuvant to equal 0.5 mL final volume. Doses administered intramuscular at week 0, 4, 8, and 24. On week week 27, there is a P falciparum Controlled Human Malaria Infection (CHMI) challenge. |
| Group 2: 30 µg FMP012 adjuvanted AS01B | EXPERIMENTAL | FMP012 with AS01B adjuvant system: 30 µg FMP012 antigen reconstituted with 500 µL AS01B adjuvant to equal 0.5 mL final volume administered intramuscular at week 2, 6, 10, and 24. On week week 27, there is a challenge with P falciparum Controlled Human Malaria Infection (CHMI). |
| Infectivity control | OTHER | Non-immunized infectivity control challenged with P falciparum Controlled Human Malaria Infection (CHMI) |
| Name | Type | Description |
|---|---|---|
| FMP012 with AS01B adjuvant system | BIOLOGICAL | Candidate malaria vaccine based on the recombinant protein FMP012, which is Escherichia coli-expressed Plasmodium falciparum cell-traversal protein for ookinetes and sporozoites (PfCelTOS) |
| P falciparum Controlled Human Malaria Infection (CHMI) | OTHER | - |
Inclusion Criteria: * Healthy adults (male or non-pregnant, non-lactating female) 18 to 50 years of age (inclusive) at the time of screening * If the subject is female, * Non-childbearing potential (ie, either surgically sterilized or one year post-menopausal), abstinent or using adequate contra...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, GSK3772701, Mosquirix, GSK4425689A |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |