Paratek Pharmaceuticals, Inc. (PRTK) reported positive preliminary efficacy data for Nuzyra's use as a post-exposure guard against pulmonary anthrax in non-human primates (NHPs). The company was purchased by Novo Holdings in September of the previous year.
Anthrax is a severe illness that can be fatal. It is an infectious disease produced by the Bacillus anthracis bacteria. In this recent study, the survival rate among NHPs treated with Nuzyra was recorded at 100% after 30 days and was maintained above 90% during the 60-day observation period. However, all NHPs given a placebo died within 10 days after exposure to B. anthracis as a result of anthrax.
The plan for Paratek is to schedule a meeting with the FDA around the middle of 2024. The goal is to agree on the final studies needed to support the supplementary New Drug Application (sNDA) for both anthrax treatments and post-exposure prophylaxis indications, as the company stated.
Nuzyra first received its approval in 2018. It's used for community-acquired bacterial pneumonia (CABP) treatments and to address acute bacterial skin and skin structure infections (ABSSSI).