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INE963 · 2 trials · 1 indication
Part A: To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
Part B and C: To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria. ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).
To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
| Arm | Type | Description |
|---|---|---|
| Cohort A1: Dose Level 1 INE963 | EXPERIMENTAL | Cohort A1: Dose Level 1 INE963 |
| Cohort A1: Dose Level 2 INE963 | EXPERIMENTAL | Cohort A1: Dose Level 2 INE963 |
| Cohort A1: Dose Level 3 INE963 | EXPERIMENTAL | Cohort A1: Dose Level 3 INE963 |
| Cohort B1: Cipargamin + INE963 | EXPERIMENTAL | Cohort B1: Cipargamin + INE963 |
| Cohort B1: SoC (Coartem) | ACTIVE_COMPARATOR | Cohort B1: SoC (Coartem) |
| Cohort B2: Cipargamin + KLU156 | EXPERIMENTAL | Cohort B2: Cipargamin + KLU156 |
| Cohort B2: SoC (Coartem) | ACTIVE_COMPARATOR | Cohort B2: SoC (Coartem) |
| Cohort C2: Cipargamin + KLU156 | EXPERIMENTAL | Cohort C2: Cipargamin + KLU156 |
| Cohort C2: SoC (Coartem) | ACTIVE_COMPARATOR | Cohort C2: SoC (Coartem) |
| Cohort A1: Dose Level 4 INE963 | EXPERIMENTAL | Cohort A1: Dose level 4 INE963 |
| Cohort A1: INE963 Dose Level 1 | EXPERIMENTAL | Cohort A1: INE963 Dose Level 1 |
| Cohort A1: INE963 Dose Level 2 | EXPERIMENTAL | Cohort A1: INE963 Dose Level 2 |
| Cohort A1: INE963 Dose Level 3 | EXPERIMENTAL | Cohort A1: INE963 Dose Level 3 |
| Cohort A1: INE963 Dose Level 4 | EXPERIMENTAL | Cohort A1: INE963 Dose Level 4 |
| Name | Type | Description |
|---|---|---|
| INE963 | DRUG | oral INE963 |
| KAE609 (Cipargamin) | DRUG | oral KAE609 (Cipargamin) |
| SoC (Coartem) | DRUG | SoC (Coartem) |
| KLU156 | DRUG | oral sachet KLU156 (KAF156 + lumefantrine) |
Inclusion Criteria: 1. Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part B and 2 to \<12 years of age for Part C at screening. 2. Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150...
INE963 is an investigational small molecule being developed for the treatment of uncomplicated Plasmodium falciparum malaria. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
INE963 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for uncomplicated Plasmodium falciparum malaria.
INE963 is in Phase 2 clinical development. It is an investigational drug and has not been approved for any use. Two Phase 2 trials have been conducted, one completed and one currently recruiting participants.
INE963 is being studied in two Phase 2 platform trials. NCT05750628 is recruiting 327 participants across Burkina Faso, Côte d’Ivoire, Gabon, Ghana, Kenya, and Uganda. NCT07235020, which enrolled 52 adults, has been completed in the same countries.
INE963 is a small molecule designed to treat uncomplicated Plasmodium falciparum malaria. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not described here.