Paratek Starts Final Stage Study Of Oral-only Omadacycline In ABSSSI

Paratek Pharmaceuticals Inc PRTK commenced final stage study of oral-only Omadacycline by dosing the first patient with acute bacterial skin and skin structure infections (ABSSSI). According to the company, the final stage trial would determine the safety and efficacy of once-daily oral-only drug compared with two-daily with ABSSSI.

The company pointed out that for the regulatory filings, the primary efficacy endpoint is the number of subjects with clinical success at the early clinical response assessment 48-72 hours following the first dosage of the trial drug.

Paratek Pharmaceuticals said the final stage, randomized, double-blind, multi-center trial in adults with moderate to severe ABSSSI would compare the safety and efficacy of once-daily oral omadacycline to twice-daily oral linezolid. The company indicated that trial would enroll about 700 patients at about 60 centers.

The company's president and CMO, Evan Loh, said, "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."

On Friday, the stock advanced $0.13, or 1.01 percent, to $13.02.