Allergan, Paratek hit late-stage acne goals, prep for sarecycline NDA
Allergan and partner Paratek Pharmaceuticals have hit their primary endpoints in two key phase 3 acne trials for their investigational med sarecycline.
The pair will now seek an FDA NDA in the second half of the year after the two “replicative” late-stage tests that saw the med outdo placebo in treating inflammatory acne lesions in subjects with moderate to severe acne.
Neither company went into exact details on the figures, but said in a statement that sarecycline “was statistically significantly (p<0.004) superior to placebo with respect to primary efficacy endpoints.”
Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties, which the companies will hope can gain a nod for moderate to severe acne in the community setting. The drug is also being studied in rosacea.
“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 R&D 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.”
Allergan owns the U.S. rights for the development and commercialization of sarecycline while Paratek retains all ex-U.S. rights.
The company has an odd history, failing in its first attempt at an IPO back in 2012 and then only going public through a reverse merger with Transept two years’ ago. Bayer, Merck and Novartis have all at one time worked with the biotech on its drug, but have all since dropped out.
Last summer, Paratek saw its shares jump by more than 20% as it posted new phase 3 data for its antibiotic omadacycline, matching Pfizer’s Zyvox (linezolid), which has a license for infections caused by Gram-positive bacteria that are resistant to other antibiotic.
The biotech was up 11% premarket on the news.