Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AN2728, 5% · 6 trials · 1 indication
PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84.
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as 'Ointment treated plaque versus (vs.) vehicle treated plaque' and 'Vehicle treated plaque vs. ointment treated plaque'.
| Arm | Type | Description |
|---|---|---|
| AN2728 ointment, 2% | EXPERIMENTAL | AN2728 ointment, 2% |
| Ointment Vehicle | PLACEBO_COMPARATOR | Ointment Vehicle |
| 1. AN2728 Ointment B | ACTIVE_COMPARATOR | 2%, administered twice daily |
| 2. AN2728 Ointment B Vehicle | PLACEBO_COMPARATOR | - |
| 3. AN2728 Ointment B | ACTIVE_COMPARATOR | 2%, administered once daily |
| 4. AN2728 Ointment B | ACTIVE_COMPARATOR | 0.5%, administered twice daily |
| 5. AN2728 Ointment B | ACTIVE_COMPARATOR | 0.5%, administered once daily |
| 1 | ACTIVE_COMPARATOR | AN2728 Ointment, 5% |
| 2 | PLACEBO_COMPARATOR | AN2728 Ointment vehicle |
| 3 | EXPERIMENTAL | AN2728 Cream, 0.3% |
| 4 | PLACEBO_COMPARATOR | AN2728 Cream Vehicle |
| 5 | ACTIVE_COMPARATOR | Betnesol®-V Creme (betamethasone 0.1 %) |
| 6 | ACTIVE_COMPARATOR | Protopic® Ointment (tacrolimus 0.1 %) |
| Name | Type | Description |
|---|---|---|
| AN2728 ointment, 2% | DRUG | AN2728 ointment, 2%, applied twice daily for 12 weeks |
| Ointment Vehicle | DRUG | Ointment Vehicle, applied twice daily for 12 weeks |
| AN2728 | DRUG | Ointment B, 2% or 0.5% applied once or twice daily |
| Placebo | DRUG | Ointment B Vehicle applied once or twice daily |
| AN2728 Ointment Vehicle | DRUG | AN2728 Ointment Vehicle, twice daily for 4 weeks. |
| AN2728 Cream, 2% | DRUG | - |
| AN2728 Cream, 1% | DRUG | - |
| AN2728 Cream, 0.3% | DRUG | - |
| AN2728 Cream Vehicle | DRUG | - |
| Betnesol®-V Creme, 0.1% | DRUG | - |
| AN2728 Ointment, 5% | DRUG | - |
| AN2728 Ointment, 0.5% | DRUG | - |
| Protopic® Ointment, 0.1 % | DRUG | - |
Inclusion Criteria: * Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals * Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all...
AN2728 is an investigational small molecule being developed for dermatology conditions, specifically plaque-type psoriasis and atopic dermatitis. Clinical trials have evaluated it as a topical ointment for mild-to-moderate atopic dermatitis in adults and adolescents, and for plaque-type psoriasis. It is not FDA approved and remains in clinical development.
AN2728 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company has sponsored clinical trials of the drug across multiple countries, including the United States and Australia.
AN2728 is in Phase 1 and Phase 2 clinical development. Completed trials include Phase 1 safety studies and Phase 2 efficacy studies for atopic dermatitis and plaque-type psoriasis. The drug is investigational and has not received FDA approval.
AN2728 has been studied in several completed trials, including NCT01258088 for plaque-type psoriasis, NCT01301508 for atopic dermatitis, NCT01602341 for adolescents with atopic dermatitis, and NCT01652885 for safety and pharmacokinetics in adolescents. All six trials are completed with no active trials ongoing.
AN2728 is not the same as AN2898, but they have been studied together. A Phase 2 trial, NCT01301508, evaluated the efficacy and safety of both AN2898 and AN2728 topical ointments for treating mild-to-moderate atopic dermatitis.