The study results confirm omadacycline as a safe and effective treatment for moderate to severe community-acquired bacterial pneumonia, demonstrating non-inferiority to moxifloxacin.
RT’s Three Key Takeaways:
- Efficacy and Safety: The study results confirm that Nuzyra (omadacycline) is a safe and effective treatment for moderate to severe community-acquired bacterial pneumonia, showing non-inferiority to moxifloxacin.
- Extensive Clinical Data: With the completion of this post-marketing study, Paratek Pharmaceuticals now has data from 1,438 pneumonia patients, which a company executive says creates the largest clinical trial dataset for pneumonia among all antibiotics approved by the FDA in the last decade.
- Advocacy for Updated Guidelines: The positive findings from the study support Paratek’s belief that there is a near-term opportunity to update the current American Thoracic Society/Infectious Diseases Society of America community-acquired pneumonia guidelines.
Paratek Pharmaceuticals announced positive top-line results from a phase 3 post-marketing study, demonstrating the efficacy and safety of its antibiotic Nuzyra (omadacycline) in treating moderate to severe community-acquired bacterial pneumonia.
For the study, Paratek compared its once-daily oral and IV, broad-spectrum antibiotic Nuzyra to moxifloxacin. Results from this double-blind study community-acquired bacterial pneumonia patients are consistent with findings from the phase 3 study “Omadacycline for Pneumonia Treatment in the Community,” which supported approval of Nuzyra by the US Food and Drug Administration (FDA) and was published in The New England Journal of Medicine in 2019.
“This study provides additional data confirming Nuzyra as an effective and well-tolerated treatment option for community-acquired bacterial pneumonia, a serious respiratory illness with significant impact to morbidity and mortality in the United States,” says Randy Brenner, chief development and regulatory officer of Paratek, in a release. “With the completion of this post-marketing study, our clinical study database now includes data from 1,438 pneumonia patients and is the largest clinical trial dataset in pneumonia across all antibiotics approved by the FDA in the last decade.
“We believe these data support a near-term opportunity to update the current American Thoracic Society/Infectious Diseases Society of America CAP (community-acquired pneumonia) guidelines.”
Study Design and Top-Line Findings
The global, phase 3 clinical study known as OPTIC-2 (Omadacycline for Pneumonia Treatment in the Community-2), compared the efficacy and safety of once-daily, IV-to-oral omadacycline to IV-to-oral moxifloxacin for treating adults with moderate to severe community-acquired bacterial pneumonia.
In the study, 670 patients were randomized. Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority in the intent-to-treat population compared to moxifloxacin at the early clinical response timepoint (72-120 hours after initiation of therapy). High rates of clinical success were observed with early clinical response rates of 89.6 % and 87.7%, for the omadacycline and moxifloxacin treatment arms, respectively.
Omadacycline also met all FDA-specified secondary endpoints, achieving non-inferiority vs moxifloxacin at the post-treatment evaluation visit five to 10 days after the completion of therapy in both the intent-to-treat population (86% for omadacycline versus 87.7% for moxifloxacin) and in the clinically evaluable population (94.1% for omadacycline versus 95.9% for moxifloxacin) as determined by investigators. Efficacy results were consistent across study populations, PORT Risk Class, and causative pathogen.
Safety Findings
In the study, omadacycline was generally safe and well-tolerated, consistent with prior studies of omadacycline and the current FDA prescribing information for Nuzyra. The most common treatment-emergent adverse events in omadacycline-treated patients (occurring in >2% of patients) were headache (3.6% with omadacycline versus 4.5% with moxifloxacin), COVID-19 (3.3% with omadacycline versus 1.2% with moxifloxacin), and AST increase (2.1% with omadacycline versus 0% with moxifloxacin). Gastrointestinal adverse events of interest were rare and infrequent for omadacycline versus moxifloxacin and included: vomiting (0% versus 0.3%), nausea (0.6% versus 1.5%), and diarrhea (0% versus 3%).
There were no cases of clostridium difficile colitis or infection in either treatment group. Rates of treatment-emergent adverse events were 27.7% for omadacycline vs. 23.5% for moxifloxacin. Drug-related treatment-emergent adverse events were 2.7% for omadacycline versus 6.9% for moxifloxacin. Discontinuation due to treatment-emergent adverse events was uncommon, 2.7% for both omadacycline and moxifloxacin. The overall mortality rate was 1.8 % and balanced with six deaths in each treatment arm.
The results of this study will be submitted for publication and for presentation at an upcoming scientific congress, according to Paratek.
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