Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DFD-29 · 2 trials · 1 indication
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
| Arm | Type | Description |
|---|---|---|
| DFD-29 | EXPERIMENTAL | DFD-29 (40 mg) extended release capsules |
| Doxycycline 40 mg | ACTIVE_COMPARATOR | Doxycycline 40 mg modified release capsules |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules matching DFD-29 |
| Name | Type | Description |
|---|---|---|
| DFD-29 | DRUG | DFD-29 (40 mg) extended release capsules |
| Doxycycline | DRUG | Doxycycline 40 mg capsules |
| Placebo | DRUG | Placebo capsules |
Key Inclusion Criteria: * Male and female subjects aged 18 years and above. * Subjects must be in good general health as determined by the investigator and supported by the medical history. * Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade ...
DFD-29 is an investigational oral small molecule being developed for the treatment of papulopustular rosacea, a form of rosacea characterized by redness and pustules. It is currently in Phase 3 clinical development and is not yet approved by the FDA.
DFD-29 is being developed by Journey Medical Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol DERM. The company is conducting clinical trials to evaluate the safety and efficacy of DFD-29 for papulopustular rosacea.
DFD-29 is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total of 653 participants enrolled. The drug is investigational and has not received FDA approval.
DFD-29 has completed two Phase 3 clinical trials: NCT05296629, which enrolled 323 participants in the United States, and NCT05343455, which enrolled 330 participants in the United States and Germany. Both trials were randomized, double-blind, and placebo-controlled studies in patients with papulopustular rosacea.
DFD-29 is a small molecule, but its specific molecular target has not been disclosed. It is being studied as an oral treatment for papulopustular rosacea, with the goal of reducing the inflammatory lesions and redness associated with the condition.