Paratek Pharmaceuticals has announced positive late-stage results for its lead commercial candidate, Nuzyra (omadacycline), to treat patients with moderate-to-severe community-acquired bacterial pneumonia (CABP).
The phase 3 double-blind Omadacycline for Pneumonia Treatment in the Community-2 (OPTIC-2) study has been comparing the efficacy and safety of once-daily intravenous (IV)-to-oral Nuzyra to IV-to-oral moxifloxacin, an antibiotic used to treat certain infections caused by bacteria, including pneumonia, skin and abdominal infections, in 670 adult patients with moderate-to-severe CABP.
Infecting over 900,000 people in the US every year, bacterial pneumonia is caused by various bacteria. The most common form, Streptococcus pneumoniae, occurs when the body is weakened and the bacteria protrudes into the lungs.
Already approved for CABP by the US Food and Drug Administration (FDA), Nuzyra is a novel antibiotic that is designed to overcome tetracycline resistance and exhibits activity across a variety of bacteria to treat CABP and acute bacterial skin and skin structure infections.
The trial met both the FDA-specified primary and secondary endpoints after Nuzyra achieved statistical non-inferiority (NI) in the intent-to-treat (ITT) population compared to moxifloxacin, achieving high rates of clinical success with early clinical response timepoint rates of 89.6%, compared to 87.7% for moxifloxacin, respectively.
In addition, Nyzyra achieved NI versus moxifloxacin at the post-treatment evaluation visit, five to ten days after the completion of therapy in both the ITT (86% for Nuzyra and 87.7% for moxifloxacin) and the clinically evaluable population (94.1% for Nuzyra versus 95.9% for moxifloxacin), with safety and tolerability consistent with prior studies and the current FDA prescribing information for Nuzyra.
Commenting on the results, Randy Brenner, chief development and regulatory officer, Paratek, said: “This study provides additional data confirming Nuzyra as an effective and well-tolerated treatment option for CABP.”
“Our clinical study database is the largest clinical trial dataset in pneumonia across all antibiotics approved by the FDA in the last decade… [and] we intend to submit the study report to the FDA and engage in label update negotiations later this year,” Brenner added.
Additionally, a phase 2b study of Nuzyra is already being conducted to evaluate the antibiotic in non-tuberculous mycobacterial pulmonary disease, a rare disease caused by Mycobacterium abscessus.