Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi [see Clinical Studies ( 14 )]. FDA label
Also known as Nifurtimox (BAYa2502)
Nifurtimox · 5 trials · 2 indications
Cure is defined as sero-reduction (in subjects ≥8 months to \<18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a ≥20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G (IgG) concentration measured by two conventional ELISA serology tests. Subjects who have missing conventional serology results at the 12 month time point were treated as failures (ie, no cure). For the primary objective in the study, superiority over placebo was confirmed if the lower limit of the 95% Confidence Interval (CI) for the nifurtimox (60-day regimen) cure rate is greater than 16%, the larger of the upper limits of the 95% CIs for historical placebo control.
Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 60-day nifurtimox treatment regimen compared to an external control group of historical placebo patients with Chagas' disease. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported.
Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point\[AUC(0-tlast)\]
Peak concentrations (Cmax) of the plasma concentration vs time profiles
AUC(0-tlast):Area under the drug-concentration vs. time curve of nifurtimox from time 0 to the last data point
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
AUC: Area under the concentration versus time curve from zero to infinity after single (first) dose
| Arm | Type | Description |
|---|---|---|
| Nifurtimox 60 days / Arm 1 | EXPERIMENTAL | Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) |
| Nifurtimox 30 days / Arm 2 | EXPERIMENTAL | Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) |
| GRP 1 - Assess relative bioavailability (4-way crossover) | EXPERIMENTAL | GROUP 1 (Treatments A, B, C, D) All treatments in Group 1 consisted of a dose of 120 mg nifurtimox (4 x 30 mg tablets). In Treatment A, dose administration was in a fasted state. For the other treatments, dose administration was in a fed state: Treatment B after a low-fat breakfast; Treatment C after a breakfast consisting of dairy products (yogurt+milk); and Treatment D after a high-calorie and high-fat breakfast. |
| GRP 2 - Assess relative bioavailability (2-way crossover) | EXPERIMENTAL | All subjects in Group 2 received a single dose of nifurtimox in each of the Treatments D and E. In Treatment D, subjects received 120 mg nifurtimox (4 x 30 mg tablets), and in Treatment E, subjects received 240 mg nifurtimox (8 x 30 mg tablets). Both treatments were administered in a fed state, after a high-calorie and high-fat breakfast. |
| GRP1 - Assess relative bioavailability(3-way cross-over) | EXPERIMENTAL | GROUP 1 (Treatments A, B, C) All 3 treatments in Group 1 consist of a dose of 120 mg nifurtimox (4 x 30 mg tablets). Participants received the 3 treatments in one of six treatment sequences under fed condition. Treatment A, dose administration with fast in vitro dissolution characteristics Treatment B, dose administration with medium in vitro dissolution characteristics Treatment C, dose administration with slow in vitro dissolution characteristics |
| GRP2 - Assess relative bioavailability (2-way cross-over) | EXPERIMENTAL | GROUP 2 (Treatments D and E) Participants received the 2 treatments in one of two treatment sequences under fed condition. Treatment D, a single dose 30 mg nifurtimox dose with medium in vitro dissolution characteristics Treatment E, a single dose of 120 mg nifurtimox |
| BAYa2502 without food | EXPERIMENTAL | Oral intake of a single 120 mg nifurtimox dose under fasted conditions |
| BAYa2502 with food | EXPERIMENTAL | Oral intake of a single 120 mg nifurtimox dose under fed conditions after ingestion of a high calorie and high fat breakfast |
| Nifurtimox (Group 1) | EXPERIMENTAL | Descriptive pharmacokinetic group |
| Nifurtimox (Group 2) | EXPERIMENTAL | The assessment of bioequivalence of the two formulation (30mg vs.120mg) |
| Name | Type | Description |
|---|---|---|
| Nifurtimox (Lampit, BAYA2502) | DRUG | For pediatric participants with body weight ≤ 40 kg: dosage 10 to 20 mg/kg/day in three divided doses. For pediatric participants with body weight \> 40 kg: 8 - 10 mg/kg/day in three divided doses. 60 days or 30 days of nifurtimox treatment |
| Placebo | DRUG | Matching placebo |
| Nifurtimox (BAYa2502) | DRUG | Oral Intake of 4 x 30 mg nifurtimox tablets |
| Nifurtimox (BAYa2502) (4 x 30 mg tablet) | DRUG | 120 mg single dose as four 30 mg tablets after a high fat, high calorie meal |
| Nifurtimox (BAYa2502) (slurry of 4 x 30 mg tablets in tap water) | DRUG | 120 mg single dose as aqueous slurry in tap water produced from four 30 mg tablets; ingestion after a high fat, high calorie meal |
| Nifurtimox (BAYa2502) (120 mg tablet) | DRUG | 120 mg single dose as one 120 mg tablet after a high fat, high calorie meal |
Inclusion Criteria: Part 1: * Male and female pediatric subjects aged 0 days to younger than 18 years * Chagas' disease diagnosed/ confirmed for a) Subjects \< 8 months of age at randomization must demonstrate direct observation of Trypanosoma cruzi by concentration test; b) Subjects ≥ 8 months to...
Nifurtimox is used to treat Chagas disease, an inflammatory, infectious condition caused by the parasite Trypanosoma cruzi. It is a small molecule therapeutic being developed by Bayer AG. The clinical program includes a Phase 3 study in children aged 0 to 17 years with Chagas disease, as well as Phase 1 studies in adults.
Nifurtimox is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical development program for the drug in Chagas disease.
Nifurtimox is in Phase 3 clinical development for Chagas disease. The Phase 3 trial, NCT02625974, evaluated the drug in children aged 0 to 17 years and has been completed. Additional Phase 1 studies have also been completed.
Nifurtimox has been studied in five completed clinical trials. These include the Phase 3 trial NCT02625974 in children with Chagas disease, and Phase 1 trials NCT03350295, NCT03334838, and NCT02606864, which assessed bioavailability and food effects in adult patients.
Yes, Nifurtimox is also known as Lampit and by the code names BAYA2502 and BAYa2502. These names refer to the same small molecule drug developed by Bayer AG for Chagas disease.