Paratek announces start of Phase III omadacycline trial

Paratek Pharmaceuticals Inc. today announced that it has begun its Phase III trial of omadacycline, which will study the drug’s effects on patients with acute bacterial skin and skin structure infections (ABSSSI).

The trial will examine the efficiency and safety of omadacycline given only orally once a day compared to linezolid twice a day orally.

“Oral antibiotic therapies for community-acquired skin infection, when effective, are advantageous because they can eliminate the need for a hospital stay, thereby substantially reducing the overall cost of treatment and limiting a patient’s exposure to secondary infection in the hospital setting," Paratek President and CMO Evan Loh said. "Unfortunately, resistance to the existing, older oral agents has led to increasing hospital visits, so there is a need for a new, effective, broad spectrum oral agent with MRSA coverage for community-acquired skin infections. Omadacycline is an excellent candidate for study in these infections as it is broad spectrum, well-tolerated, and available in a once-daily oral formulation. We look forward to building on the strength of our clinical program, having already demonstrated robust efficacy and safety in our Phase III study of IV to oral omadacycline in ABSSSI, reported earlier this year.”