Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Biltricide · 1 trial · 1 indication
Clinical cure was defined as zero egg counts at 14-21 days post treatment as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
| Arm | Type | Description |
|---|---|---|
| Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg | EXPERIMENTAL | Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1. |
| Part 1, Cohort 2: Biltricide (racemate praziquantel) 40 mg/kg | EXPERIMENTAL | Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1. |
| Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg | EXPERIMENTAL | Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1. |
| Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg | EXPERIMENTAL | Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1. |
| Part 1, Cohort 5: Levo Praziquantel 30 mg/kg | EXPERIMENTAL | Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1. |
| Part 1, Cohort 6: Levo Praziquantel 45 mg/kg | EXPERIMENTAL | Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1. |
| Part 1, Cohort 7: Levo Praziquantel 60 mg/kg | EXPERIMENTAL | Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1. |
| Part 2, Cohort 8: Levo Praziquantel 50 mg/kg | EXPERIMENTAL | Participants aged 13-24 months months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1. |
| Part 2, Cohort 9: Levo Praziquantel 50 mg/kg | EXPERIMENTAL | Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1. |
| Name | Type | Description |
|---|---|---|
| Biltricide (racemate praziquantel) oral tablets | DRUG | Biltricide (600 mg tablet) was administered to participants at a dose of 20 mg/kg in Part 1, Cohort 1 and at a dose of 40mg/kg in Part 1, Cohort 2. |
| Racemate Praziquantel ODT | DRUG | Racemate Praziquantel (PZQ) (150) mg was administered at a dose of 40 mg/kg in Part 1, Cohort 3 and at a dose of 60 mg/kg in Part 1, Cohort 4. |
| Levo Praziquantel ODT | DRUG | Levo PZQ (150 mg) was administered at a dose of 30 mg/kg in Part 1 Cohort 5, 45 mg/kg Part 1 Cohort 6, 60 mg/kg Part 1 Cohort 7, 50 mg/kg Part 2 Cohort 8, and 50 mg/kg Part 2 Cohort 9. |
Inclusion Criteria: * Male and female children aged 2 to 6 years (Part 1) and 3 to 24 months (Part 2) * S. mansoni positive diagnosis defined as positive egg counts in stool (greater than \[\>\]1 egg/1 occasion) according to World Health Organization (WHO) classification : light (1-99 eggs per gram...
Biltricide is used for the treatment of schistosomiasis, a parasitic disease caused by Schistosoma worms. It is being studied specifically for use in children and infants infected with Schistosoma mansoni, one of the species that causes the infection.
Biltricide is developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is traded over-the-counter under the ticker symbol MKGAF.
Biltricide is in Phase 2 clinical development. It is an investigational drug for schistosomiasis and has not yet been approved by regulatory authorities. One Phase 2 trial has been completed, and no trials are currently active.
Biltricide has been studied in one completed Phase 2 clinical trial, registered under the identifier NCT02806232. The trial was an open-label, dose-finding study that evaluated the safety and efficacy of the drug in children and infants infected with Schistosoma mansoni.
Biltricide is the brand name for praziquantel, a small-molecule antiparasitic drug. It is being developed by Merck KGaA for the treatment of schistosomiasis in pediatric populations.