Allergan, a leading global pharmaceutical company and Paratek Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, announced that two (2) Phase 3 trials of sarecycline for the treatment of moderate to severe acne met their 12 week primary efficacy endpoints. Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting. Based on these data, Allergan plans to file a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in the second half of this year.
“The positive efficacy results observed in the pivotal phase 3 clinical trials indicate that sarecycline can be an effective treatment option for patients with moderate to severe acne.” said David Nicholson, Chief Global Research & Development Officer at Allergan. “We look forward to submitting a new drug application for sarecycline and bringing to market a potential new option for physicians treating patients with acne.”
“We are pleased with the results of the sarecycline Phase 3 program and Allergan’s intention to move ahead with an NDA submission for approval in the U.S. by the end of 2017,” said Evan Loh, M.D., President, Chief Operating Officer and Chief Medical Officer, Paratek. “Sarecycline is a narrow spectrum antibiotic, which we believe can offer meaningful clinical benefits for patients afflicted with acne.”
About SC1401 and SC1402
Both SC1401 & SC1402 were designed to be replicative phase 3 randomized, multicenter, double-blind, placebo-controlled studies to evaluate the efficacy and safety of 1.5 mg/kg per day of sarecycline compared to placebo in the treatment of moderate to severe acne.
The primary objective was to evaluate the efficacy and safety of oral sarecycline 1.5 mg/kg per day compared to placebo in treating inflammatory acne lesions in subjects with moderate to severe acne based on Investigators Global Assessment (IGA) scale score and inflammatory lesion counts. Patients were randomized (1:1) into two treatment groups to receive either sarecycline tablets (60 mg, 100 mg and 150 mg, providing a dose of 1.5 mg/kg/day) or placebo once a day for 12 weeks.
Sarecycline was statistically significantly (p < 0.004) superior to placebo with respect to primary efficacy endpoints. The most common adverse events (>2%) reported in the sarecycline group were nausea (3.2%), nasopharyngitis (2.8%), and headache (2.8%). The rate of discontinuation due to adverse events among sarecycline-treated patients in the two studies combined was 1.4%.
