Paratek Reports Positive Phase III Data On Antibiotic Drug

Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) announced positive results from a phase III study (OASIS) comparing its antibiotic candidate omadacycline to Pfizer Inc.’s (NYSE:PFE) Zyvox for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

The OASIS study evaluated the efficacy and safety of an intravenous to oral once-daily dose of omadacycline against a twice daily dose of Zyvox.

Results showed that the study met the FDA specified primary efficacy endpoint of early clinical response (ECR). The ECR for omadacycline was found to be 84.8% as compared to Zyvox which stood at 85.5%. Additionally, the study met two European Medicines Agency specified co-primary efficacy endpoints for post-treatment evaluation. The candidate was found to be safe and well-tolerated.

Paratek intends to present results from this study along with data for the secondary endpoints at an upcoming scientific congress.

Apart from ABSSSI, Paratek is also conducting additional studies on omadacycline for other indications. The company expects to announce top-line data from a phase III study comparing omadacycline to Bayer (DE:BAYGN) AG’s (OTC:BAYRY) Avelox for the treatment of community acquired bacterial pneumonia (CABP) as early as the third quarter of 2017. Last month, Paratek initiated a phase Ib study on omadacycline for the treatment of urinary tract infections.

Paratek plans to submit a new drug application for omadacycline for the treatment of both ABSSSI and CABP in the first half of 2018. We note that omadacycline enjoys Fast Track status in the U.S.

Other than omadacycline, another advanced candidate in the company’s pipeline is sarecycline. It is currently in phase III studies for the treatment of moderate-to-severe acne vulgaris. While Allergan plc (NYSE:AGN) has development and commercialization rights to sarecycline in the U.S., all ex-U.S. rights are with Paratek.

Paratek is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Pfizer, sporting a Zacks Rank #1 (Strong Buy) and Bayer, carrying a Zacks Rank #2 (Buy).