Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M5717 · 1 trial · 1 indication
The time (in days) to first recorded parasitemia (parasite count \>0) since the first negative blood smear (parasite count of 0) after treatment (followed at least by 1 subsequent visit with a negative blood film), i.e. the time without a positive blood smear. Median time and 95% CI was estimated using the Kaplan Meier method for each cohort.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: M5717 (60 mg) + Pyronaridine | EXPERIMENTAL | Participants received single oral dose of M5717 60 milligram (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (Participants \>= 65 kilogram \[kg\]) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen. |
| Cohort 2: M5717 (200 mg) + Pyronaridine | EXPERIMENTAL | Participants received single oral dose of M5717 200 mg plus pyronaridine 720 mg (Participants \>= 65 kg) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen. |
| Cohort 3: M5717 (660 mg)+ Pyronaridine | EXPERIMENTAL | Participants received single oral dose of M5717 660 mg plus pyronaridine 720 mg (Participants \>= 65 kg) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen. |
| Cohort 4: Atovaquone-proguanil | EXPERIMENTAL | Participants received orally 3 doses of Malarone (fixed-dose combination of atovaquone-proguanil) once daily in a 3-day treatment regimen. |
| Name | Type | Description |
|---|---|---|
| M5717 60 mg | DRUG | Participants received single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition |
| Pyronaridine | DRUG | Participants received Pyronaridine tablets orally single dose of 720 (Participants \>= 65 kg) and 540 mg (Participants \>= 45 to \< 65 kg) on Study Day 1 under fasting condition |
| Atovaquone-Proguanil | DRUG | Participants received Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen. |
| M5717 200 mg | DRUG | Participants received single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition |
| M5717 660mg | DRUG | Participants received single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition |
Inclusion Criteria: * Participants with Asymptomatic Plasmodium falciparum Malaria with no Fever or other sign of Acute Uncomplicated Malaria and, with Microscopic confirmation using Giemsa-stained thick film, and a Parasitemia of \>= 40 to \<= 10,000 Asexual Parasites/Microliter (μL) of Blood. * A...
M5717 is an investigational small molecule being developed for malaria infection. It is being studied as a chemoprevention treatment in combination with pyronaridine for adults and adolescents with asymptomatic Plasmodium falciparum infection. The drug is currently in Phase 2 clinical development.
M5717 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's efficacy, safety, and pharmacokinetics in combination with pyronaridine for malaria chemoprevention.
M5717 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its potential use in preventing malaria infection in specific patient populations.
M5717 has been studied in one completed Phase 2 clinical trial, identified as NCT05974267. This trial, called CAPTURE-2, evaluated the efficacy, safety, and pharmacokinetics of M5717 in combination with pyronaridine as chemoprevention in adults and adolescents with asymptomatic Plasmodium falciparum infection.
No, M5717 is not the same as pyronaridine. M5717 is the investigational drug being developed by Merck & Company, Inc., while pyronaridine is a separate antimalarial agent used in combination with M5717 in clinical trials. The combination is being studied for malaria chemoprevention.