Phase III OPTIC/OASIS-1 trials of Nuzyra in CABP and ABSSSI published in New England Journal of Medicine.- Paratek Pharma

Paratek Pharmaceuticals announced The New England Journal of Medicine (NEJM) published detailed results from the OPTIC and OASIS-1 Phase III clinical trials of Nuzyra (omadacycline). Nuzyra is a modernized tetracycline that is a once-daily intravenous (IV) and oral for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Both studies published in NEJM met all primary and secondary endpoints and showed that Nuzyra was safe and well-tolerated. Nuzyra was approved by the FDA on October 2, 2018 for the treatment of adults with CABP and ABSSSI and is now commercially available in the United States.

The global pivotal Phase 3 registration study known as OASIS-1 evaluated the efficacy and safety of an IV to oral once-daily Nuzyra against twice-daily linezolid over a seven to 14-day course of therapy in 645 adult patients. OASIS-1 demonstrated that Nuzyra was non-inferior to linezolid for treating ABSSSI, with a similar safety profile. Efficacy results were consistent across study populations and sub-populations, type of skin infection and causative pathogen including MRSA. In the modified intent-to-treat population (mITT), Nuzyra (n=316) was non-inferior (10% NI margin) to linezolid (n=311) for ECR (84.8% vs. 85.5%; difference [95% CI]: -0.7 [�6.3, 4.9]). Nuzyra also was non-inferior to linezolid for IACR at PTE in the mITT (86.1% vs. 83.6%; difference: 2.5 [-3.2, 8.2]) and clinically evaluable (96.3% vs. 93.5%; difference 2.8 [-1.0, 6.9]) populations. In both groups, efficacy was comparable for methicillin-susceptible and methicillin-resistant Staphylococcus aureus infections, which account for nearly half of all ABSSSI isolates in the United States. Serious TEAEs occurred in 3.7% of Nuzyra patients and 2.5% of linezolid patients, none of which were considered related to study drug.

See: "Omadacycline for Community-Acquired Bacterial Pneumonia" Roman Stets et al. New England Journal of Medicine, 2019; 380:517-527 DOI: 10.1056/NEJMoa1800201