Phase 3 trials for acne treatment show promising results

Dr. Stein GoldThe tetracycline-derived antibiotic sarecycline from Allergan plc and Paratek Pharmaceuticals Inc. for the treatment of moderate-to-severe acne has been found effective and safe, according to the results of two phase 3 trials.

“Sarecycline is a new option in oral antibiotics within the tetracycline family for the treatment of moderate to severe acne,” says Linda Stein Gold, M.D., director of clinical research for the Department of Dermatology at Henry Ford Hospital in Detroit, who was a clinical investigator for one of the two phase 3 trials.

“Sarecycline is a once-daily dosing drug with a narrow spectrum of activity, which is good, along with good anti-inflammatory properties,” Dr. Stein Gold tells Dermatology Times.

Another advantage of the drug is that it has weight-based dosing at 1.5 mg/kg.

Sarecycline was studied in patients with moderate-to-severe acne.  “Generally, these patients have more severe inflammatory acne lesions,” Dr. Stein Gold says.

The randomized, multicenter, double-blind, placebo-controlled trials evenly divided patients to receive sarecycline or placebo.

“Sarecycline tablets were dosed as 60 mg, 100mg or 150mg, which corresponded to roughly 1.5 mg/kg,” Dr. Stein Gold says.

For the two trials, patients were treated once daily for 12 weeks.

“Sarecycline was found to be statistically superior to placebo in patients receiving an Investigator's Global Assessment (IGA) of clear or almost clear and in reducing inflammatory lesion counts,” Dr. Stein Gold reports.

“The drug seems to be safe, effective and well tolerated,” Dr. Stein Gold says.

The most common side effects were nausea (3.2%), nasopharyngitis (2.8%) and headache (2.8%). 

“There was also a low dropout rate in the sarecycline group (1.4%) in the combined studies,” Dr. Stein Gold says.

As for the mechanism of action of the drug, “it has both antibiotic and anti-inflammatory properties,” Dr. Stein Gold says. “Sarecycline could be first line therapy for any moderate to severe acne patient in whom an oral antibiotic is necessary.”

FDA submission of the drug is planned for the second half of 2017.​

Dr. Stein Gold envisions sarecycline being used in combination with topical medications, including benzoyl peroxide and retinoids or topical dapsone.

“The approach I generally use is combination therapy initially for the first 3 to 5 months, and then stopping the oral antibiotic and maintaining on topical therapy,” Dr. Stein Gold says. “However, the Phase 3 trials of sarecycline required monotherapy. But in actual practice, oral antibiotics are usually not used as monotherapy.”

Disclosure: Dr. Stein Gold is an advisor and speaker for Allergan.