- A Phase 2 clinical trial assessing Foamix Pharmaceuticals' (FOMX +2.6%) FMX103 for the treatment of moderate-to-severe papulopustular rosacea (PR) met its primary and secondary endpoints showing a statistically significant reduction in inflammatory lesions compared to vehicle.
- The 233-subject, Germany-based study, called EMIRA, investigated two concentrations of FMX103 (1.5% and 3.0%) in patients with PR, a chronic skin condition characterized by redness and bumps (papules) or pimples (pustules). The primary endpoint was the absolute change from baseline in inflammatory lesion count at Week 12. The mean reductions in lesion count for the 1.5% concentration, 3.0% concentration and vehicle (control) were 21.1, 19.9 and 7.8, respectively (p<0.001). The percent reductions were 61.4%, 55.5% and 29.7%, respectively (p<0.001).
- Both doses of FMX103 were also statistically significantly better than vehicle in reducing IGA score by two grades and in reaching "clear" (score = 0) or "almost clear" (score = 1) at Week 12 (p<0.01 and p<0.05, respectively).
- FMX103 was safe and well-tolerated.
- The company intends to advance FMX103 to Phase 3 development.
- As its name implies, Foamix develops drugs that are delivered in a topical foam formulation.