Core Insights - The Phase 3 clinical study OPTIC-2 demonstrated that omadacycline is statistically non-inferior to moxifloxacin for treating moderate to severe community-acquired bacterial pneumonia (CABP) [2][3] - Omadacycline achieved high early clinical response rates of 89.6% compared to 87.7% for moxifloxacin, meeting all FDA-specified primary and secondary endpoints [2][9] - The study results will be submitted for publication and presented at a scientific congress, indicating ongoing commitment to transparency and scientific discourse [5] Company Overview - Paratek Pharmaceuticals, Inc. focuses on innovative medical therapies, particularly in hospital and public health settings, with its lead product being NUZYRA (omadacycline) [3][6] - The company has a collaboration with Zai Lab Limited for the development and commercialization of omadacycline in the greater China region, retaining all other global rights [12] - Paratek received a contract from BARDA valued at approximately $304 million to support the development of NUZYRA for various applications, including anthrax treatment [7] Study Findings - The study included 670 patients and confirmed that omadacycline is generally safe and well-tolerated, with treatment-emergent adverse events (TEAEs) occurring at rates of 27.7% for omadacycline versus 23.5% for moxifloxacin [10] - The most common TEAEs for omadacycline were headache (3.6%), COVID-19 (3.3%), and AST increase (2.1%), with gastrointestinal events being rare [10] - The overall mortality rate in the study was 1.8%, balanced across both treatment arms, indicating no significant safety concerns [10] Future Directions - The company plans to engage in label update discussions with the FDA as early as Q4 2024, aiming to update treatment guidelines based on the study results [9] - The clinical study database now includes data from 1,438 pneumonia patients, representing the largest clinical trial dataset in pneumonia for any antibiotic approved in the last decade [9]
Paratek Pharmaceuticals Announces Positive Top-line Efficacy and Safety Data from Post-Marketing Study of NUZYRA® (omadacycline) for Patients with Moderate to Severe Community-Acquired Bacterial Pneumonia