Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) is a clinical stage biopharmaceutical company which is engaged in the development and commercialization of tetracycline based therapeutics. The company recently reported the completion of enrollment for Phase 3 study of of its oral-only Omadacycline, which is also its lead drug candidate. The drug is targeted to treat patients suffering from Acute Bacterial Skin and Skin Structure Infections (ABSSSI). It has solid potential going ahead as the use of this treatment may eliminate the need of hospital stay for ABSSSI patients.
The study targets to enroll up to 700 patients, spread across 50 centers in the US. Paratek will have different primary endpoints for the US and EU filing. The US requirement is concerned with the number of subjects with clinical success at the early clinical response assessment 48-72 hours after the first dose of study drug while the primary endpoint for EU will be clinical response at the post therapy evaluation, which is also known as 'test of cure'. The EU endpoint appears to be more clinically comprehensive, but the US one will be quicker to achieve.
