Dive Brief:
- Foamix Pharmaceuticals’ topical minocycline foam cut the numbers of papules and pustules by over 60%, according to topline results from a Phase 2 study announced this week.
- Foamix shares rose by over 17% from last Friday's close in trading Monday and Tuesday.
- Papulopustular rosacea is a chronic and disfiguring skin disease with no cure. The estimated market value for rosacea is potentially worth as much as $1.2 billion, according to the company.
Dive Insight:
Moderate-to-severe papulopustular rosacea is usually treated with oral antibiotics such as minocycline and doxycycline, but repeated use of these treatments can increase the risk of microbial resistance.
Foamix Pharmaceuticals’ has aimed its efforts developing a topically-delivered antibiotic formulation. This means the drug is readily absorbed only where it is needed, avoiding systemic exposure and potentially reducing antibiotic resistance.
The Phase 2 study compared FMX103 to a vehicle foam and showed significant reduction in the number of inflammatory lesions in the treatment group. Reduction in lesions is an endpoint likely to mean a lot to people with rosacea. The treatment was also considered safe and well tolerated.
"We believe the positive data from our clinical trial could support advancement into Phase 3, and look forward to reviewing these results with the FDA,” said Dov Tamarkin, CEO of Foamix.
Rosacea is more than just teen spots. Papulopustular rosacea is a chronic skin condition, with facial redness, flushing and stinging, as well as inflamed skin lesions on the nose, cheeks, chin and forehead. There is no cure available for rosacea, which affects around 16 million people in the US.
Foamix has two other minocycline foam preparations in parallel development, both in Phase 2: FMX101, a 4% minocycline foam for moderate-to-severe acne, and FMX102, a 1% minocycline foam for impetigo.