Paratek Pharmaceuticals, Inc .'s PRTK shares are up more than 22% since it announced positive results from a phase III study of its lead pipeline candidate, omadacycline for the treatment of patients with community-acquired bacterial pneumonia (CABP).
The study compared omadacycline, a once daily oral and IV, broad spectrum investigational antibiotic to Bayer AG's BAYRY Avelox (moxifloxacin).
The phase III randomized, global study, OPTIC, met the primary endpoint of statistical non-inferiority of omadacycline to Avelox for the treatment of adults with CABP at the early clinical response (ECR) of 72-120 hours after initiation of therapy. It was also found to be statistically non-inferior to Avelox in the post-treatment evaluation. Adverse events in omadacycline arm happened in less than 4% of the study population.
We remind investors that omadacycline earlier produced positive results in a phase III registration study for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in comparison to Pfizer Inc.'s PFE Zyvox. Based on data from both the studies, the company is planning to file for FDA approval in the first quarter of 2018 and for EU approval later in 2018.
This development comes close on the heels of positive results announced in partnership with Allergan plc AGN last month for another candidate, sarecycline for the potential treatment of acne. The study met its primary endpoint. The companies intend to file for FDA approval for the drug in the second half of the year.
The back-to-back positive news pushed up Paratek's share price by 38.6% in the past one month. It outperformed the Zacks classified Medical - Generic Drugs industry, which declined 3.8% in the same period.
Paratek currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
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