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OZ439 · 1 trial · 1 indication
Assessing the transmissibility by oocyst detection in mosquito midgut preparations following direct and membrane (indirect) feeding.
| Arm | Type | Description |
|---|---|---|
| OZ439 | EXPERIMENTAL | Each participant in the cohort will be inoculated on Day 0 with \~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. when PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants will be randomised to receive either OZ439 or a control group (primaquine treatment). In the first cohort 500 mg OZ439 will be administered as a single dose. Doses used in subsequent cohort(s) will be determined following a review of observed safety and pharmacodynamic drug effects. |
| Primaquine | ACTIVE_COMPARATOR | Each participant in the cohort will be inoculated on Day 0 with \~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. when PCR quantification of all participants is ≥ 5,000 parasites/mL, they will receive a single dose of 480 mg of piperaquine phosphate to clear blood stage parasitemia. When gametocytemia is at the peak (approximately 15 days after administration of piperaquine), participants will be randomised to receive either OZ439 or a control group (primaquine treatment). Primaquine is a positive control for OZ439, to be administered 15 mg as a single dose. |
| Name | Type | Description |
|---|---|---|
| OZ439 | DRUG | - |
| Primaquine | DRUG | - |
Inclusion Criteria: Demography: * Adult (male and females) participants between 18 and 55 years of age, inclusive who do not live alone (from Day 0 until at least the end of the anti-malarial drug treatment) and be contactable and available for the duration of the trial (maximum of 6 weeks). * Bod...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
OZ439 is an investigational small molecule being developed for the treatment of malaria. It is an infectious disease therapeutic currently in clinical development. The drug has been studied in a Phase 1 clinical trial to evaluate its effectiveness as a gametocytocidal and transmission blocking agent.
OZ439 is being developed by CNS Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol CNSP. The drug is an investigational small molecule intended for the treatment of malaria, an infectious disease.
OZ439 is in Phase 1 clinical development. It has completed a Phase 1 trial that enrolled 11 participants. The drug is investigational and has not been approved by regulatory authorities for commercial use.
OZ439 has been studied in one completed Phase 1 clinical trial with the identifier NCT02431650. The trial, titled "Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent," enrolled 11 participants in Australia and included healthy volunteers aged 18 years and older.
OZ439 is also known as artefenomel. It is an investigational small molecule being developed for the treatment of malaria. The drug has been evaluated in clinical trials for its potential to block transmission of the malaria parasite.