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Paratek Reports Positive Phase 2 Clinical Data on its New Antibiotic PTK 0796 in Late Breaker Presentation at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
Date:10/26/2008

BOSTON, Oct. 26 /PRNewswire/ -- Paratek Pharmaceuticals, Inc. today announced positive Phase 2 data for the Company's lead antibiotic, PTK 0796, a first-in-class aminomethylcycline (AMC). The Phase 2 study compared safety and efficacy of oral and intravenous (IV) forms of PTK 0796 to Zyvox(R) 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. In the clinically evaluable population of patients (N=188), the clinical success rates were 98.0% and 93.2% for PTK 0796 and Zyvox, respectively. The Phase 2 data are being reported and discussed today at a press briefing at 10:00 a.m. and in a Late Breaker poster presentation at 12:15 p.m. at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), taking place in Washington, D.C.

Paratek's U.S.-based Phase 2 multi-center, randomized (1:1), investigator-blinded, comparative trial enrolled 234 patients with cSSSI who required initial 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).

Dr. Stuart Levy, Co-founder and Chief Scientific Officer of Paratek Pharmaceuticals, stated, "New antibiotics are critically needed as multi-drug resistance grows at alarming rates in both the hospital and community settings. The Phase 2 results for Paratek's PTK 0796 are highly encouraging, particularly in context with previous findings showing activity of PTK 0796 against a broad spectrum of drug resistant bacteria, including MRSA. Overall, the Phase 2 data indicate a convincing
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SOURCE Paratek Pharmaceuticals, Inc.
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