Paratek Pharmaceuticals, Inc. announced positive top-line efficacy data for NUZYRA® (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death. In the study, a 100% survival rate was observed in omadacycline-treated NHPs at the end of the treatment period (30 days) and a survival rate over 90% was observed over the entirety of the 60-day observation period.

All NHPs treated with placebo died due to anthrax within 10 days of exposure to B. anthracis. Top-line data from this study triggered an additional procurement of NUZYRA under the company?s Project BioShield contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Oral NUZYRA tablets associated with this procurement were manufactured in the United States as part of the company?s U.S. onshoring efforts.

A meeting with FDA will be planned for the middle of 2024 to align on the final studies required to support the sNDA submission for both anthrax treatment and PEP indications. In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.