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Paratek Pharmaceuticals To Initiate Clinical Trial Sites For Phase 2b Study Of NUZYRA - Quick Facts

Biopharmaceutical company Paratek Pharmaceuticals, Inc. (PRTK) announced Wednesday the initiation of clinical trial sites for its Phase 2b study exploring the potential utility of Nuzyra (omadacycline) as a treatment for Nontuberculous Mycobacterial (NTM) pulmonary disease caused by mycobacterium abscessus complex (MABc).

Pulmonary infections caused by MABc, an orphan disease with no FDA-approved antibiotic therapies, affects approximately 11,500 patients in the U.S. The standard of care typically involves a combination of multiple antibiotics, which can often be life-long in duration.

Nuzyra is a novel antibiotic FDA approved with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

The Phase 2b study is a placebo-controlled, randomized monotherapy study of M. abscessus pulmonary disease in patients in the early treatment phase who are not receiving other treatments.

The U.S.-based study will enroll approximately 75 subjects, randomized in a 1.5 to 1 ratio. The primary study endpoints are improvement in symptoms and safety and tolerability following 12 weeks of treatment.

Due to the small numbers of patients with this rare disease, Paratek expects the study will take about two years to complete enrollment.

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