Paratek Advances NUZYRA For Pulmonary Anthrax With Positive Animal Rule Data And Additional BARDA Procurement

Paratek Pharmaceuticals, Inc. announced positive top-line results from two animal studies supporting its Animal Rule development program for the treatment of pulmonary anthrax. The studies evaluated NUZYRA® (omadacycline) in both a non-human primate (NHP) inhalation anthrax model and a pivotal rabbit inhalation anthrax model. Data from the NHP study were previously presented at ESCMID Global 2025 in Vienna, while findings from the rabbit study are scheduled for presentation at a scientific conference in spring 2026. Anthrax is caused by the bacterium Bacillus anthracis and can result in severe illness or death if untreated.

The encouraging results have triggered an additional procurement of NUZYRA under Paratek’s Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response. The oral NUZYRA tablets included in this procurement were manufactured in the United States, reflecting the company’s U.S.-based onshoring efforts supported through the federal contract.

"On the heels of the positive findings we reported last year for post exposure prophylaxis (PEP), we now have confirmatory findings in both NHP and rabbit models in therapeutic efficacy studies, further validating NUZYRA's potential to effectively treat pulmonary anthrax," said Randy Brenner, Chief Development and Regulatory Officer of Paratek. "These data represent a significant and continued advancement of our program under the contract with BARDA which is designed to support an sNDA submission to gain an indication for the treatment of pulmonary anthrax. Paratek has been at the forefront of addressing potential bioterrorism and threats to public health associated with anthrax, and we are grateful to BARDA for continuing their longstanding partnership with us."

With these studies completed, only one additional pivotal NHP study remains planned to support submission of a supplemental New Drug Application (sNDA) under the U.S. Food and Drug Administration Animal Rule pathway for a pulmonary anthrax treatment indication. If approved, the indication would trigger the final procurement under the current BARDA agreement.

In parallel, Paratek is also advancing a separate SNDA program for post-exposure prophylaxis (PEP). The development program has been funded in whole or in part by federal support from BARDA through the U.S. Department of Health and Human Services, reinforcing the government’s focus on strengthening preparedness against public health threats.