Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Artefenomel (OZ439)
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 drug being developed by Sanofi for the treatment of Plasmodium falciparum infection, the parasite that causes the most severe form of malaria. It is a synthetic compound studied as part of combination antimalarial therapy and remains in clinical development.
Artefenomel is being studied for the treatment of uncomplicated Plasmodium falciparum malaria. Its clinical testing has focused on patients with this infection, including a Phase 2 trial conducted across Benin, Burkina Faso, Gabon, Kenya, and Uganda in patients aged 14 years and older.
Artefenomel is developed by Sanofi, the French pharmaceutical company whose shares trade under the ticker SNY. Sanofi has advanced the compound into mid-stage clinical testing for malaria, and it is also known by the designation OZ439.
Artefenomel is in Phase 2 clinical development. It is an investigational drug and has not been approved for commercial use. One Phase 2 trial has been completed, and no trials are currently listed as active.
Artefenomel has been evaluated in the Phase 2 trial NCT03660839, titled a study of the clinical and parasiticidal activity and pharmacokinetics of different doses of Artefenomel and ferroquine in patients with uncomplicated Plasmodium falciparum malaria. That trial enrolled 140 patients, was controlled and randomized, and has been completed.
Yes, Artefenomel is also known as OZ439. OZ439 is the compound code used for the same investigational antimalarial drug developed by Sanofi, so searches for either name refer to the identical asset in Phase 2 development for Plasmodium falciparum infection.