05.03.2024 14:19:02
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Paratek Reports Positive Data For Nuzyra As Post-exposure Prophylaxis Of Pulmonary Anthrax In NHPs
(RTTNews) - Paratek Pharmaceuticals, Inc. (PRTK) Tuesday announced positive topline efficacy data for Nuzyra as post-exposure prophylaxis (PEP) of pulmonary anthrax in non-human primates (NHPs).
Paratek Pharmaceuticals was acquired by Novo Holdings in September last year.
Anthrax, an infectious disease caused by bacteria called Bacillus anthracis (B. anthracis), can lead to severe illness and death.
In the study, a 100% survival rate was observed at the end of 30 days in NHPs treated with Nuzyra, and survival rate was more than 90% over the 60-day observation period. All NHPs treated with placebo died due to anthrax within 10 days of exposure to B. anthracis.
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, Paratek said in a statement.
Nuzyra was first approved in 2018 for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
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