Paratek reports positive late-stage results for Nuzyra in bacterial pneumonia

Paratek Pharmaceuticals has recently reported promising results from a late-stage clinical trial for its leading commercial drug candidate, Nuzyra (omadacycline), aimed at treating patients with moderate-to-severe community-acquired bacterial pneumonia (CABP). The phase 3 OPTIC-2 study evaluated the efficacy and safety of once-daily intravenous (IV) followed by oral Nuzyra compared to IV-to-oral moxifloxacin, an existing antibiotic used for various bacterial infections, including pneumonia, skin, and abdominal infections. The study included 670 adult patients diagnosed with moderate-to-severe CABP.

In the United States, bacterial pneumonia affects over 900,000 individuals annually, with Streptococcus pneumoniae being the most prevalent strain. This infection typically occurs when the immune system is compromised, allowing bacteria to invade the lungs. Nuzyra, already approved by the U.S. Food and Drug Administration (FDA) for CABP, is a novel antibiotic developed to counteract tetracycline resistance and is effective against various bacterial strains responsible for CABP and acute bacterial skin infections.

The clinical trial successfully met both the primary and secondary endpoints specified by the FDA. Nuzyra demonstrated statistical non-inferiority (NI) compared to moxifloxacin in the intent-to-treat (ITT) population, achieving high rates of clinical success. The early clinical response rate for Nuzyra was 89.6%, slightly higher than the 87.7% observed for moxifloxacin.

Furthermore, Nuzyra maintained its non-inferiority at the post-treatment evaluation visit, conducted five to ten days after completing the therapy. In the ITT population, Nuzyra achieved a clinical success rate of 86%, compared to 87.7% for moxifloxacin. Among the clinically evaluable population, Nuzyra showed a success rate of 94.1%, closely matching the 95.9% success rate of moxifloxacin. The safety and tolerability profiles of Nuzyra were consistent with previous studies and the existing FDA prescribing information.

Randy Brenner, Chief Development and Regulatory Officer at Paratek, commented on the findings, stating that the study provides additional evidence supporting Nuzyra as an effective and well-tolerated treatment option for CABP. Brenner also highlighted that their clinical trial dataset is the largest for pneumonia among all antibiotics approved by the FDA in the past decade. Paratek intends to submit the study report to the FDA and engage in label update negotiations later this year.

In addition to the OPTIC-2 study, Paratek is conducting a phase 2b trial to assess Nuzyra's efficacy in treating non-tuberculous mycobacterial pulmonary disease, a rare condition caused by Mycobacterium abscessus.

The successful results from the OPTIC-2 study solidify Nuzyra's position as a viable treatment for moderate-to-severe CABP, offering an alternative to existing antibiotics like moxifloxacin. With its ability to tackle various bacterial strains and its proven efficacy and safety, Nuzyra stands out as a significant advancement in the treatment of bacterial pneumonia. As Paratek continues its efforts to expand Nuzyra's applications and update its label, patients and healthcare providers can look forward to more effective treatment options for bacterial infections.