Paratek, FDA agrees on Special Protocol Assessment for pneumonia study
Paratek Pharmaceuticals has reached agreement with the FDA on its second Special Protocol Assessment (SPA) related to the phase III program design for the company's lead antibiotic candidate, omadacycline (formerly PTK 0796), this time for community-acquired bacterial pneumonia (CABP).
Omadacycline is a broad-spectrum, first-in-class aminomethylcycline antibiotic with oral and IV formulations that address the leading organisms that cause bacterial infections such as CABP and serious (acute) bacterial skin and skin structure infections (ABSSSI).
This agreed upon SPA, and previous one for ABSSSI, designate the trials’ design as double-blind, randomized and controlled and will compare omadacycline to the standard of care therapies. The agreed upon SPA means the FDA can not alter its perspective on the issues of design, execution or analyses of the trial.
"This is the first SPA agreement for CABP under the FDA's new early response endpoint that we are aware of, and we believe that it clarifies the regulatory path to approval and supports the appropriateness of omadacycline for these two important infections (ABSSSI and CABP)," said Dr. Gary J. Noel, chief medical officer, Paratek.