Paratek Presents New Analysis From Combined Phase 3 Skin Infection Studies

Paratek Pharmaceuticals, Inc. recently presented a new analysis of combined data from the company’s two, pivotal Phase 3 clinical studies of omadacycline in acute bacterial skin and skin structure infections (ABSSSI) when methicillin- (MRSA) or multidrug-resistant (MDR) S. aureus was the baseline pathogen. Omadacycline, a first-in-class aminomethylcycline, demonstrated high clinical success rates for skin infections caused by S. aureus even when MDR or Panton–Valentine leucocidin positive (PVL+) isolates were present. The results were presented for the first time at ASM Microbe 2018.

“One of the main challenges in treating ABSSSI is antibiotic resistance and the prevalence of severe skin infections caused by antibiotic-resistant pathogens specifically MRSA strains,” said Evan Loh, MD, President, Chief Operating Officer, and Chief Medical Officer, Paratek. “This new combined analysis underscores the utility of omadacycline against serious community-acquired infections, including multidrug-resistant Staphylococcus aureus and demonstrates that, if approved, omadacycline has the potential to help address the growing global health challenge of antibiotic resistance.”

The combined OASIS-1 and OASIS-2 analysis showed that antibiotic resistance was common, occurring in 61.3% of S. aureus solates identified at baseline with more than one-third identified as MDR (≥3 antibiotic classes). The rate of clinical success at post-treatment evaluation (PTE) with omadacycline was 81% when MDR SA was present and was comparable to SA overall at 83.0%. Clinical success at PTE with linezolid occurred in 82.3% of patients when MDR SA was present and 81.3% with SA overall.

MRSA was identified in 32.4% of patients. Clinical success rates at PTE for patients with MRSA were high in each treatment arm (84.4% for omadacycline; 81.5% for linezolid). PVL presence correlates with community acquired MRSA and was identified in 89.3% of the characterized MRSA isolates. Clinical success rates at PTE for treatment of patients with PVL+ MRSA were high (84.5% for omadacycline; 83.0% for linezolid).

OASIS-1 (Omadacycline in Acute Skin and Skin Structure Infections Study) and OASIS-2 were Phase 3, randomized, double-blind, global studies in adults with ABSSSI. OASIS-1 evaluated the safety and efficacy of once-daily, IV-to-oral omadacycline against twice daily linezolid. OASIS-2 evaluated the safety and efficacy of once-daily, oral-only omadacycline compared to twice-daily, oral-only linezolid. In both studies, omadacycline demonstrated non-inferiority to linezolid for the treatment of ABSSSI and met all primary and secondary efficacy outcomes designated by the U.S. Food and Drug Administration and the European Medicines Agency. Omadacycline was generally safe and well-tolerated across both studies.

Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. The company’s lead product candidate, omadacycline, is a new, once-daily oral and intravenous broad-spectrum antibiotic being developed for the treatment of serious community-acquired bacterial infections, including community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and urinary tract infections (UTI). Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the US Food and Drug Administration for the target indications of ABSSSI, CABP, and UTI. Paratek has completed Phase 3 development activities for omadacycline in CABP and ABSSSI, and its New Drug Applications to the US FDA have been accepted for priority review. The Company plans to submit a marketing authorization in the European Union in the second half of this year. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region, and retains all remaining global rights.

Under a research agreement with the US Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

Paratek’s second product candidate, SEYSARA (sarecycline), is being developed by Allergan in the US as a new once-daily oral therapy for the treatment of acne. Allergan has completed Phase 3 development activities for Seysara and its new drug application was accepted for review by the U.S. FDA in December 2017. Paratek retains all ex-U.S. rights to sarecycline.

Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories. For more information, visit www.ParatekPharma.com.