Paratek Reports Positive Results From Phase II Skin Infections Study
Paratek Pharmaceuticals, a developer of therapeutics for treating bacterial infections, has announced positive Phase II data of the company’s lead antibiotic, PTK 0796, a first-in-class aminomethylcycline.
The Phase II study compared safety and efficacy of oral and intravenous forms of PTK 0796 to Zyvox in the treatment of patients with complicated skin and skin structure infections (cSSSIs).
Paratek’s trial met its primary safety and tolerability endpoint, demonstrating no differences between PTK 0796 and Zyvox in incidence or pattern of adverse events (AEs). Of note, no patients discontinued therapy with PTK 0796 because of AEs, and no drug-related serious adverse events (SAEs) were seen for either drug, the company said. In the clinically evaluable population of patients (N=188), the clinical success rates were 98% and 93.2% for PTK 0796 and Zyvox, respectively.
Paratek’s US-based Phase II multi-center, randomized (1:1), investigator-blinded, comparative trial enrolled 234 patients with cSSSIs who required initial intravenous (IV) therapy. Patients were randomized to receive up to 14 days of therapy of either PTK 0796 (100mg once-daily IV with 200mg once-daily oral step-down) or Zyvox (600mg twice-daily IV with 600mg twice-daily oral step-down).
Thomas Bigger, Paratek’s president and CEO, said: “PTK 0796 is the only once-a-day, oral and IV methicillin-resistant Staphylococcus aureus-active compound in development with a spectrum broad enough for single agent treatment of cSSSI and community-acquired pneumonia. We expect to initiate our pivotal Phase III trials in the US and overseas for the treatment of cSSSI patients, including those with diabetic foot infections, in the first quarter of 2009.”