A New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) for clascoterone cream 1%, an investigational treatment for acne.
Clascoterone is being developed by Cassiopea SpA. It is a first-in-class topical androgen receptor inhibitor. The cream is designed to reach the androgen receptors of the sebaceous gland to inhibit the local effects of dihydrotestosterone, a key driver of acne lesion development.
The NDA is supported by two phase 3 trials in which patients were randomized to receive either clascoterone cream 1% twice daily or a vehicle cream for 12 weeks. Results from both trials showed that treatment with clascoterone was associated with a statistically significant improvement in all primary end points (success rate in Investigator’s Global Assessment [IGA], change from baseline in non-inflammatory lesion counts, change from baseline in inflammatory lesion counts).
In an open-label safety study, patients continued on clascoterone for up to an additional 9 months. Results from this study showed no hormonal imbalance was observed in patients even after long-term treatment and with an enlarged drug application surface. Dermal adverse events associated with therapy included erythema/reddening on the face and trunk and scaling/dryness on the face.
“If approved, clascoterone cream 1% will be the first new mechanism of action in the treatment of acne in nearly 40 years, offering dermatologists and patients a new and effective therapeutic alternative,” said Diana Harbort, CEO of Cassiopea.
For more information visit cassiopea.com.