Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Artefenomel · 1 trial · 1 indication
ACPR:absence of parasitemia at Day 28, irrespective of axillary temperature(AT), participants not meeting any criteria of early therapy failure(ETF):Danger signs(DS)/symptoms of complicated(SoC)/severe malaria(SM) at Day 1, 2 or 3 in presence of parasitemia, concomitant to at least 1 positive parasitemia;or parasitemia on Day 2 \>Day 0 irrespective of AT;or parasitemia on Day 3 with AT\>=37.5 degree Celsius (°C);or parasitemia count on Day 3 \>=25 percent (%) on Day 0, or late clinical failure (LCF):DS/SM in presence of parasitemia between Day 4 and 28,concomitant to at least one positive parasitemia;or presence of parasitemia and AT\>=37.5°C on Day 4 to Day 28, or late parasitological failure(LPF):presence of parasitemia between Day 7 and 28 and AT\<37.5°C and without rescue therapy. PCR-corrected ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with reinfection.
| Arm | Type | Description |
|---|---|---|
| Ferroquine 400 milligram (mg) | EXPERIMENTAL | On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition. |
| Ferroquine 400 mg + Artefenomel 300 mg | EXPERIMENTAL | On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension. |
| Ferroquine 400 mg + Artefenomel 600 mg | EXPERIMENTAL | On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension. |
| Ferroquine 400 mg + Artefenomel 1000 mg | EXPERIMENTAL | On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension. |
| Name | Type | Description |
|---|---|---|
| Artefenomel (OZ439) | DRUG | Pharmaceutical form: Granules for oral suspension Route of administration: Oral |
| Ferroquine (SSR97193) | DRUG | Pharmaceutical form: Capsule Route of administration: Oral |
Inclusion criteria : Participants (14-69 years old inclusive) with body weight within 35 and 90 kilograms (kg), with uncomplicated Plasmodium falciparum (P. falciparum) malaria, with a fever as defined with axillary temperature greater than or equal to (\>=) 37.5 degree Celsius (°C) or oral/ rectal...
Artefenomel is an investigational small molecule being developed for the treatment of Plasmodium falciparum infection, specifically uncomplicated malaria caused by this parasite. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Artefenomel is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical trials for the treatment of Plasmodium falciparum infection.
Artefenomel is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. One Phase 2 clinical trial has been completed, and no active trials are currently ongoing.
Artefenomel has been studied in one completed Phase 2 clinical trial registered as NCT03660839. This trial investigated the clinical and parasiticidal activity and pharmacokinetics of different doses of Artefenomel and Ferroquine in patients with uncomplicated Plasmodium falciparum malaria, enrolling 140 participants across Benin, Burkina Faso, Gabon, Kenya, and Uganda.
Artefenomel is a synthetic peroxide antimalarial that works by generating reactive oxygen species in the presence of heme, which is released during hemoglobin digestion by the malaria parasite. This oxidative stress damages parasite proteins and membranes, leading to parasite death. It is being studied for the treatment of Plasmodium falciparum infection.