Shares of Paratek Pharmaceuticals Inc. (NASDAQ: PRTK) saw a huge gain early on Tuesday after the company provided a critical update on its late-stage pneumonia trial. Specifically, the firm reported positive top-line results from a global, pivotal Phase 3 clinical study comparing its once-daily oral and intravenous, broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia.
Since 2014, this stock has gotten absolutely beaten up, dropping below the $10 mark in just the past year. This stock had been as high as $100 in the past five years.
Ultimately, this study represents the second positive Phase 3 registration study of omadacycline, which will be used to support marketing applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority in the intent-to-treat (ITT) population compared to moxifloxacin at the early clinical response (ECR) 72 to 120 hours after initiation of therapy. The ECR rates for the omadacycline and moxifloxacin treatment arms were 81.1 % and 82.7%, respectively.
The secondary endpoints evaluated omadacycline at the post-treatment evaluation visit five to 10 days after the completion of therapy in both the ITT population and in the clinically evaluable population as determined by investigators. The secondary endpoints also achieved statistical non-inferiority.
Michael Bigham, board chair and chief executive at Paratek, commented:
This successful study demonstrates the potential of omadacycline to treat community-acquired bacterial pneumonia, a significant and serious health issue. This Phase 3 study in pneumonia along with our previously announced successful Phase 3 study in skin infections satisfy the regulatory filing requirements of our special protocol assessment with the FDA. We look forward to sharing these data with the FDA and EMA. Our plan is to submit our NDA in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018.
Shares of Paratek traded up 31% Tuesday morning to $24.42. The consensus analyst price target is $3.80 and the 52-week trading range is now $9.80 to $25.00.