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Also known as DWP-450
Botulinum toxin, Type A · 3 trials · 1 indication
The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.
The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
| Arm | Type | Description |
|---|---|---|
| Botulinum toxin, Type A | EXPERIMENTAL | Botulinum toxin, Type A |
| Placebo | PLACEBO_COMPARATOR | 0.9 % sterile, unpreserved saline |
| Botulinum toxin, Tyoe A | EXPERIMENTAL | DWP-450 (Botulinum toxin, Type A) |
| Name | Type | Description |
|---|---|---|
| Botulinum toxin, Type A | BIOLOGICAL | Botulinum toxin, Type A |
| 0.9% sterile, unpreserved saline | OTHER | Placebo |
| DWP-450 (Botulinum purified neurotoxin, Type A) | BIOLOGICAL | Botulinum toxin, Type A |
Inclusion Criteria: * Subjects is an adult, of at least 18 years of age * Subject is able to provide informed consent and comply with study instructions * Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS * Subject has moderate to severe g...
Botulinum toxin, Type A is being developed by Evolus for the treatment of glabellar frown lines, the vertical lines that form between the eyebrows. The clinical program enrolled adults 18 years and older with this condition in placebo-controlled Phase 3 studies conducted in the United States.
Botulinum toxin, Type A targets SNAP25, a hydrolytic enzyme. The molecule acts on this target as part of its mechanism in treating glabellar frown lines, the indication studied in its clinical program.
Botulinum toxin, Type A is being developed by Evolus, Inc., which trades under the ticker EOLS. The company sponsored the Phase 3 program for the product, referred to as DWP-450 in its trials, in glabellar frown lines.
Botulinum toxin, Type A is in Phase 3 development for glabellar frown lines. Both of its Phase 3 trials have been completed, and no trials are currently listed as active. It remains an investigational product in clinical development.
Botulinum toxin, Type A was studied in two completed Phase 3 trials: NCT02334436 (EV-002), which enrolled 324 participants, and NCT02334423 (EV001), which enrolled 330. Both were randomized, double-blind, placebo-controlled studies of DWP-450 in glabellar frown lines, run in the United States.