Paratek Makes Milestone Movement in Late-Stage Trial

By Chris Lange Updated Jan 13, 6:41AM EST · Published Jun 17, 10:05AM EDT

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Paratek Makes Milestone Movement in Late-Stage Trial — © Thinkstock

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.

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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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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.