OASIS-2 phase III trial of Nuzyra in skin infection published in The Lancet Infectious Diseases.- Paratek Pharma

Paratek Pharmaceuticals announced The Lancet Infectious Diseases published detailed results from the OASIS-2 Phase III clinical trial of Nuzyra (omadacycline). Once-daily, oral Nuzyra met all primary and secondary clinical study endpoints and was shown to be safe and effective for the treatment of acute bacterial skin and skin structure infections (ABSSSI). One of three pivotal, Phase III clinical studies demonstrating the efficacy and safety of Nuzyra in skin infections and pneumonia, OASIS-2 (Omadacycline in Acute Skin Structure Infections Study), evaluated the efficacy and safety of once-daily, oral-only Nuzyra compared to twice-daily oral-only linezolid in 735 adults with ABSSSI. OASIS-2 demonstrated that Nuzyra was non-inferior to linezolid for treating ABSSSI, with a similar safety profile. Efficacy was consistent across study populations, type of skin infection and causative pathogen including methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MRSA) infections.

In the modified intent-to-treat population (mITT), Nuzyra (n=360) met the FDA-specified primary endpoint of statistical non-inferiority (NI) (10% NI margin, 95% confidence interval) compared to linezolid (N=360) at the early clinical response (ECR), 48 to 72 hours after the first dose of study drug. The ECR rate for Nuzyra as 87.5% compared to 82.5% for linezolid. Additionally, Nuzyra met statistical NI compared to linezolid for the EMA-specified co-primary endpoints at the post therapy evaluation (PTE), 7 to 14 days after completion of therapy in the mITT and the Clinically Evaluable (CE) populations. Clinical success rates at PTE in the mITT population for the Nuzyra and linezolid arms were 84.2% vs. 80.8%, respectively; and in the CE population were 97.9% vs. 95.5%, respectively. Efficacy observed in OASIS-2 was consistent and similar to results from the OASIS-1 study, which evaluated the efficacy and safety of an IV to oral once-daily Nuzyra against twice-daily linezolid. In the OASIS-2 study, there was a low rate of study treatment discontinuation for both omadacycline and linezolid patients at 10.9% vs. 14.2%, respectively.

See: "Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase III, double-blind, multicentre, randomised, controlled, non-inferiority trial." William O'Riordan et al. The Lancet infectious Diseases August 29, 2019DOI:https://doi.org/10.1016/S1473-3099(19)30275-0