Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abametapir 0.74% w/w · 5 trials · 2 indications
Proportion of index subjects randomized into the study who are lice free at all follow up visits through to the Day 14 visit. The index subject of a household was the youngest person within that household with at least 3 live lice present, as assessed over a period of up to 15 minutes at the Screening Visit.
Percentage of hatched eggs pre treatment relative to percentage of hatched eggs post treatment for the abametapir and vehicle treated eggs following 14 day incubation. The difference between post treatment percent hatching and pre-treatment percent hatching was calculated i.e. post-treatment minus pre-treatment hatching percent.
The evaluation of irritation is based on Modified Berger procedure and is accepted as standard methodology for assessment of cumulative irritation potential. The assessment of all patch sites for irritation symptoms will be visually assessed by a trained evaluator using the numerical equivalents (0-7) where 0 is the least irritation potential and 7 is the maximum irritation potential. The scoring will be done on daily basis from baseline through Day 21 visit. The final reported outcome is a mean of the scores over 21 days.
Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation
| Arm | Type | Description |
|---|---|---|
| Abametapir Lotion 0.74% w/w | ACTIVE_COMPARATOR | Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. |
| Vehicle Lotion | PLACEBO_COMPARATOR | Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver. |
| Sodium Lauryl Sulfate | OTHER | Positive control applied 0.2 mL topically under occlusive condition |
| Saline 0.9% | OTHER | Negative control applied 0.2 mL topically under occlusive condition |
| Abametapir Lotion 0.74% | ACTIVE_COMPARATOR | 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
| 0.1% sodium lauryl sulfate | OTHER | Concurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
| Name | Type | Description |
|---|---|---|
| Abametapir Lotion 0.74% w/w | DRUG | Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day. |
| Vehicle Lotion | DRUG | Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day. |
| Sodium Lauryl Sulfate | DRUG | Sodium Lauryl Sulfate is prepared as a 0.2% aqueous solution by the site for topical administration, and applied 21 times over consecutive days under occlusive conditions, will serve as a positive control. |
| Saline 0.9% | DRUG | A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control |
| Placebo | DRUG | - |
| 0.1% sodium lauryl sulfate | OTHER | - |
Inclusion Criteria: 1. Male or female, aged six months of age or older. 2. Is in good general health based on medical history. 3. Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-fre...
Abametapir 0.74% w/w is a small molecule lotion being developed for the treatment of head lice and head lice infestation. It is applied as a topical lotion. Dr. Reddy's Laboratories Ltd is developing the product, which has been studied in placebo-controlled, randomized, double-blind clinical trials.
Abametapir 0.74% w/w is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company has sponsored the clinical development program for the lotion, including Phase 1 dermal safety studies, a Phase 2 ovicidal efficacy study, and a Phase 3 efficacy and safety study.
Abametapir 0.74% w/w is in Phase 1 development overall, though its clinical program has included a completed Phase 2 study and a completed Phase 3 study. It is investigational and has not been approved. All three completed trials in the program are now inactive.
Abametapir 0.74% w/w has been studied in completed trials including NCT02097485, a Phase 2 ovicidal efficacy and safety study in Australia; NCT02062073, a Phase 1 dermal sensitization study; NCT02062060, a Phase 3 efficacy and safety study; and NCT02061813, a Phase 1 dermal irritation study. All are completed.
Across the completed clinical program, 754 participants have been enrolled in trials of abametapir 0.74% w/w. The studies were randomized, double-blind, and placebo-controlled. Enrollment ranged from 40 participants in a Phase 1 dermal irritation study to 325 participants in the Phase 3 head lice infestation study.