Health and Healthcare
Paratek Makes Milestone Movement in Late-Stage Trial
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Paratek Pharmaceuticals Inc. (NASDAQ: PRTK) saw its shares take a solid jump early on Friday after the results from its late-stage trial were released. The company announced that the Phase 3 registration study comparing its once-daily, broad spectrum antibiotic, omadacycline, to linezolid in the treatment of acute bacterial skin and skin structure infections has met the U.S. Food and Drug Administration (FDA)-specified primary efficacy endpoint of early clinical response.
Additionally, the study met the two European Medicines Agency (EMA)-specified co-primary efficacy endpoints for post-treatment evaluation. This positive study is the first of two Phase 3 registration studies designed to support omadacycline regulatory applications for the FDA and EMA.
According to management, these Phase 3 data are highly encouraging and continue to support confidence in the efficacy and safety profile of omadacycline, which has now been evaluated in more than 1,000 subjects in clinical trials.
This successful completion of the first registration study is a major milestone for Paratek.
Michael Bigham, chairman and CEO of Paratek, commented:
The successful achievement of these primary efficacy and secondary outcomes, combined with the safety and tolerability outcomes for both the oral and IV formulations of omadacycline is a significant step towards securing regulatory approval and advancing omadacycline to commercialization. Increasingly, patients and physicians are faced with the growing challenge that existing antibiotic therapies are failing as pathogens develop resistance. The positive data from this registration study demonstrate the clear potential of omadacycline to treat serious community-acquired infections where resistance is of concern.
Shares of Paratek were up 11% at $18.25 shortly after Friday’s opening bell, within a 52-week trading range of $12.05 to $29.83.
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