-- Third procurement to be split into two procurements based on the achievement of specific anthrax development milestones
-- Next procurement expected in early 2024
BARDA and Paratek have agreed the next procurement of NUZYRA anthrax treatment courses will be split into two equal procurements based on the achievement of specific development milestones toward both treatment and post-exposure prophylaxis (PEP) indications of pulmonary anthrax.
The first of these procurements will be triggered by the delivery of positive top-line data from a dose-ranging efficacy study for PEP of inhalation anthrax in non-human primates (NHPs). The company expects this data to be available in the first quarter of 2024. The second of these procurements will be triggered by BARDA’s receipt of positive top-line data from a combination of two studies, a dose-ranging efficacy study in NHPs and a pivotal efficacy study in rabbits for the treatment of inhalation anthrax, which the company anticipates could be available as early as the fourth quarter of 2024. The trigger for the final procurement of NUZYRA continues to be Paratek’s receipt of sNDA approval from the FDA for the treatment of inhalation anthrax. The company will provide further specificity on these timelines as the anthrax development program progresses.
“We thank BARDA for the continued funding of our comprehensive NUZYRA development program for PEP and treatment of pulmonary anthrax and are pleased to announce these important contract modifications to further build on our promising in vitro and in vivo animal data generated to date,” said
In
About
The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in
Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential
In 2019, Paratek was awarded a contract from the
For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter.
About NUZYRA
NUZYRA (omadacycline) is a novel once-daily antibiotic with both oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.
Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.
Forward-Looking Statements
This press release contains forward-looking statements including statements related to our overall BARDA contract, our execution under the contract, and potential utility of NUZYRA to address potential health emergencies, including pandemics. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended
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