Paratek Pharmaceuticals, Inc. (PRTK - Free Report) announced positive results from a phase III study (OASIS-2) comparing its antibiotic candidate omadacycline to Pfizer Inc.’s (PFE - Free Report) Zyvox for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The study met the key primary and secondary endpoints and Paratek Pharma looks set to file a new drug application (NDA) with the FDA in the first half of 2018. Shares were up more than 5% in after-hours trading.
The OASIS-2 study evaluated the efficacy and safety of an oral once-daily dose of omadacycline against a twice daily dose of Zyvox.
The study met the FDA specified primary efficacy endpoint of statistical non-inferiority (NI) at early clinical response (ECR), 48 to 72 hours after the first dose of the drug in the study. The ECR for omadacycline was found to be 87.5% compared to 82.5% for Zyvox.
Additionally, the study met statistical NI in European Medicines Agency specified co-primary endpoints for post-treatment evaluation (PTE). The clinical success rates in modified intent-to-treat population for the omadacycline and Zyvox arms were 84.2% and 80.8%, respectively. The rates were 97.9% for omadacycline versus 95.5% in Zyvox arm in the clinically evaluable populations.
We remind investors that omadacycline has now shown positive results in three phase III studies, namely OASIS-2, OASIS-1 and OPTIC studies.
The OASIS-2 study data shows that omadacycline can be prescribed as an oral-only dosing regimen in the outpatient setting. This is expected to reduce the need for hospital admission for the treatment of ABSSSI.
Data from OASIS-1 announced last year showed that the candidate met the FDA specified primary efficacy endpoint of ECR. The ECR for omadacycline was found to be 84.8% compared to 85.5% in the Zyvox arm.
Data from the OPTIC study announced in Apr 2017 demonstrated statistical non-inferiority of omadacycline to Bayer AG’s (BAYRY - Free Report) Avelox for the treatment of adults with community-acquired bacterial pneumonia (CABP) at 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.
Paratek intends to present results from these studies along with data for the secondary endpoints at an upcoming scientific congress.
The NDA for omadacycline will be for the treatment of both ABSSSI and CABP and will include data from all three studies. We note that omadacycline enjoys Fast Track status in the U.S.
The company also intends to file for FDA approval for another pipeline candidate, sarecycline, for the treatment of acne, in the second half of the year. Paratek is developing this candidate along with Allergan plc (AGN - Free Report) and announced positive results in the first quarter of 2017. The study met its primary endpoint.
The positive developments have pushed up Paratek’s share price by 62% so far this year. It outperformed the Zacks classified Medical – Generic Drugs industry, which increased 8.7% 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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