Data from a Phase 1 study of Paratek Pharmaceuticals' (NASDAQ:PRTK) broad spectrum antibiotic omadacycline showed intravenous administration produced steady-state concentrations in the plasma and key structures that were 3x higher than tigecycline in healthy subjects. On the safety front, there were no serious adverse events following IV dosing and there was a lower incidence of gastrointestinal adverse events compared to tigecycline.
The results were presented at the European Congress of Clinical Microbiology and Infectious Diseases ((ECCMID)) in Vienna.
COO and CMO Evan Loh, M.D., says, “Throughout our clinical development program, we have worked to generate a thorough understanding of all aspects of omadacycline and share that information with the scientific and clinical community. These data add to the growing body of evidence to support omadacycline as an effective agent in the treatment of serious acquired bacterial infections, particularly where resistance is of concern to prescribing physicians.”
The company plans to file its U.S. marketing application as early as Q1 2018 followed by its filing in Europe.
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