Paratek Pharmaceuticals today announced promising findings in a phase 3 clinical trial that compared its broad-spectrum antibiotic omadacycline to moxifloxacin for treating patients with moderate to severe community-acquired bacterial pneumonia (CABP).
The Food and Drug Administration (FDA) approved the drug, a modified tetracycline antibiotic sold under the Nuzrya brand name, in 2018 for the treatment of CABP and skin infections. Omadacycline is designed to overcome tetracycline resistance and has shown activity against both gram-positive and gram-negative bacteria, including antibiotic-resistant strains.
In the lead-up to FDA approval, clinical trials had shown that the drug was noninferior to moxifloxacin for treating CABP.
Support for updating clinical guidelines
In a press release, Randy Brenner, MS, Partek's chief development and regulatory officer, said the new trial confirms that omadacycline is an effective and well-tolerated option for treating CABP. "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," he said.
He said the company believes the latest findings support a potential update to American Thoracic Society/Infectious Diseases Society of America guidelines for treating CABP. Paratek said the firm will submit the results for publication.
Two phase 3 studies in 2019 showed the omadacycline was just as effective as standard antibiotics for treating CABP and skin infections, but some experts said the clinical value of the new drug is unclear.