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Paratek begins dosing in Phase III trial of omadacycline to treat ABSSSI

Paratek Pharmaceuticals has dosed first patient in its Phase III clinical trial of its lead drug candidate, omadacycline, to treat acute bacterial skin and skin structure infections (ABSSSI).

The trial is designed to evaluate the efficacy and safety of omadacycline compared with linezolid in ABSSSI.

Omadacycline is the first in a new class of tetracyclines called aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria.

The drug is being developed as a once-daily oral and intravenous antibiotic for use as empiric monotherapy when resistance is of concern.

The ABSSSI trial is the first of two planned Phase III trials of omadacycline, while the second trial, for the treatment of community acquired bacterial pneumonia (CABP), will start enrolling patients later this year.

Paratek Pharmaceuticals chairman and CEO Michael Bigham said: "The initiation of our registration trial for ABSSSI represents an important milestone for Paratek as a company.

"We believe that omadacycline has the potential to become an important empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, urinary tract infections, and other bacterial infections when resistance is of concern."

Around 650 adult participants will be enrolled from about 100 centers worldwide in the randomized, double-blind, multi-center Phase III trial, which will compare the safety and efficacy of omadacycline IV/PO to linezolid IV/PO for treating adults with ABSSSI.