Paratek Pharmaceuticals Inc (NASDAQ:PRTK)
Paratek Pharmaceuticals Inc (NASDAQ:PRTK) posted promising top-line data from an international, pivotal Phase III clinical study assessing its once-daily oral and IV, investigational antibiotic, omadacycline to moxifloxacin in the cure of patients with CABP. This trial shows the second promising Phase 3 registration trial of omadacycline, which will be utilized to advance marketing applications to the U.S. FDA and the European Medicines Agency.
Michael Bigham, the CEO and Chairman of Paratek Pharmaceuticals Inc (NASDAQ:PRTK), reported that this successful trial shows the potential of omadacycline to cure community-acquired bacterial pneumonia, a grave and worrying health issue. This Phase 3 trial in pneumonia along with previously reported successful Phase III trial in skin infections meet the regulatory submission requirements of special protocol evaluation with the U.S. FDA. They expect sharing this report with the U.S. FDA and EMA. Their plan is to file their NDA in the United States as early as Q1 2018 with an EMA filing later in 2018.
The international, pivotal Phase III clinical trial known as OPTIC compared the efficacy and safety of once-daily administered, omadacycline to moxifloxacin for curing adults with CABP. In the trial, 774 subjects were randomized. Omadacycline fulfilled the FDA-specified main objective of statistical non-inferiority in the intent-to-treat population as against moxifloxacin at the ECR 72-120 hours after start of treatment. The ECR rates for the moxifloxacin and omadacycline treatment arms were 82.7% and 81.1 %, respectively.
Paratek Pharmaceuticals Inc (NASDAQ:PRTK) reported that the FDA-specified secondary objectives assed omadacycline at the PTE visit 5-10 days subsequent to the completion of treatment in both the ITT population and in the clinically evaluable population as decided by investigators. The secondary objectives also recorded statistical non-inferiority.
Community-acquired bacterial pneumonia involves almost 3.3 million hospitalizations in the U.S. each year with a notable mortality risk of over 5% noted in observational trials, placing a considerable burden on the healthcare system. Antibiotic resistance is a global concern as susceptibility rates have declined across large number of antibiotics since 2010, underlining the need for novel, effective therapies.
Van Loh, M.D., President, the Chief Medical Officer and Chief Operating Officer at Paratek Pharmaceuticals Inc (NASDAQ:PRTK), reported that they now have witnessed over 1,500 subjects in the clinical plan and that they are satisfied with the tolerability, efficacy and safety profile that has been developed.
|Last Price a/o 3:21 PM EST||$18.60|
|Market Cap (mlns)||$ 490.67M|
|Shares Outstanding (mlns)||26.38M|
|Share Float (mlns)||26.38M|
|Short Interest Ratio||2.22|
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About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.