I don’t know if rosacea sufferers really need another tetracycline variant, but Allergan has published some promising Phase III trial data for Sarecycline as a treatment for the lesions of moderate to severe acne.
Whilst no longer being directly promoted as a treatment for rosacea (and indeed it is not clear if Allergan will be pursuing Sarecycline as an officially FDA approved treatment for rosacea) Paratek, the owners of the intellectual property, do describe it as both an acne and rosacea treatment.
Rosacea sufferers have known for many years that tetracyclines have multiple methods of action in rosacea.
Are you looking for a systemic tetracycline based treatment to add to your rosacea regime? If so, read on.
What we now know as Sarecycline started as WC-3035, which first came to the attention of Rosacea News back in 2007 – see 9 New Drugs in Development for Rosacea
Whats so good about Sarecycline?
According to Paratek, Sarecycline has “the potential to provide a best in class oral acne and rosacea treatment” due to the following features.
- Narrow spectrum of activity targeting acne and rosacea specific pathogens (P. acnes, staphylococcus aureus)
- Limited activity against aerobic gram-negative gastrointestinal organisms compared to minocycline and doxycycline
- Demonstrated anti-inflammatory activity
- Higher lipophilicity at physiologically relevant pH allowing better penetration into lipid rich sebaceous follicular tissues
- Long half-life enabling true once-a-day dosing
Sarecycline Press Release
DUBLIN and BOSTON, March 27, 2017 /PRNewswire/ — Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), 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.”