Allergan and Paratek announced positive results from two Phase 3 studies of sarecycline for the treatment of moderate to severe acne.
The two studies, SC1401 & SC1402, were replicative, randomized, multicenter, double-blind, placebo-controlled Phase 3 trials evaluating the efficacy and safety of sarecycline 1.5 mg/kg/day (60mg, 100mg and 150mg) vs. placebo in patients with moderate to severe acne. The primary efficacy endpoint was cure of inflammatory acne lesions based on Investigators Global Assessment (IGA) scale score and inflammatory lesion counts after 12 weeks.
Both studies achieved the primary endpoint, with sarecycline showing a statistically significant superiority over placebo in the treatment of inflammatory acne lesions (P<0.004). Sarecycline was found to be safe and tolerable, with the most common adverse events presenting as nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). Based on these study data, Allergan intends to file a New Drug Application (NDA) to the FDA in the second half of this year.
Sarecycline is an oral, once-daily, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties.