1883. A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of IV to Oral Omadacycline to Moxifloxacin for the Treatment of Adult Subjects with CABP (The OPTIC Study).
Session: Poster Abstract Session: Clinical Study with New Antibiotics and Antifungals
Saturday, October 7, 2017
Room: Poster Hall CD
Posters
  • 87779 ProEd_ID Week OPTIC SAF EFF Pstr 7124 02OCT2017.pdf (331.3 kB)
  • Background: Omadacycline (OMC), a novel aminomethylcycline antibiotic, has demonstrated non-inferiority to linezolid for the treatment of acute bacterial skin and skin structure infections. Here we report the results of Omadacycline for Pneumonia Treatment In the Community (OPTIC) Study, a phase 3 study in adults with community-acquired bacterial pneumonia (CABP).

    Methods: The OPTIC was a randomized (1:1), double-blind, global study comparing OMC and moxifloxacin (MOX) for the treatment of adults with CABP (PORT Risk Class II [≤15% total enrollment], III, or IV). Subjects could have received a single dose of a short-acting antibiotic within the 72 hours prior to the first dose of study drug (≤25% total enrollment). Subjects started treatment with OMC 100 mg IV q12h x 2 doses then 100 mg IV q24h, or MOX 400 mg IV q24h. After a minimum of 3 days IV therapy they could switch to oral therapy (OMC 300 mg q24h or MOX 400 mg q12h); total treatment duration was 7-14 days. Early Clinical Response (ECR; 72-120 hours after first dose) was defined as survival, no receipt of rescue antibacterial therapy and improvement in at least 2 of 4 subject symptoms (cough, sputum production, pleuritic chest pain, dyspnea) without deterioration in any of these 4 symptoms. Investigator’s Assessment of Clinical Response (Post Therapy Evaluation [PTE] 5-10 days after last dose), was defined as survival with resolution of signs and symptoms of the infection to the extent that further antibacterial therapy was not necessary. A total of 774 subjects were randomized (intent to treat [ITT]. population, N=386 OMC, N=388 MOX).

    Results: Median age was 62.0 years and 20.4% were >75 years. 28.0% of subjects were PORT IV. Efficacy results for OMC vs MOX were: ECR 81.1% vs 82.7% [risk difference (RD) -1.6; 95% confidence interval (CI): –7.1, 3.8]; clinical success at PTE 87.6% vs 85.1% [RD 2.5; 95% CI: –2.4, 7.4]. In the clinically evaluable population (N = 340 OMC, N = 345 MOX) the clinical success at PTE was 92.9% vs 90.4%, [RD 2.5; 95% CI: –1.7, 6.8]. Treatment-emergent adverse events (TEAEs) were reported in 41.1% vs 48.5%; serious TEAEs in 6.0% vs 6.7% and study drug discontinuation due to TEAE in 5.5% vs 7.0% of OMC and MOX treated subjects, respectively.

    Conclusion: OMC was non-inferior to MOX in the treatment of adults with CABP and was safe and well tolerated.

    Roman Stets, MD, PhD1, Monica Popescu, MD2, Joven Gonong, MD, FPCCP3, Ismail Mitha, MD4, William Nseir, MD5, Andrzej Madej, MD, PhD6, Courtney Kirsch, BS7, Anita Das, PhD8, Lynne Garrity-Ryan, PhD7, Judith N. Steenbergen, PhD8, Amy Manley, BS8, Paul Eckburg, MD8, Stephen Villano, MD9, Evan Tzanis, BA8, Paul McGovern, MD8 and Evan Loh, MD7, (1)City clinical Hospital #6, Zaporizhzhia, Ukraine, (2)SF Pantelimon Clinical Emergency Hospital, Bucharest, Romania, (3)Lung Center of the Philippines, Manilla, Philippines, (4)Lakeview Hospital, Benoni, South Africa, (5)Holy Family Hospital, Nazareth, Israel, (6)Dept of Internal Medicine and Pharmacology, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland, (7)Paratek Pharmaceuticals, King of Prussia, PA, (8)Paratek Pharmaceuticals, Inc., King of Prussia, PA, (9)Paratek Pharmaceuticals (At time of Study), King of Prussia, PA

    Disclosures:

    R. Stets, None

    M. Popescu, None

    J. Gonong, None

    I. Mitha, None

    W. Nseir, None

    A. Madej, None

    C. Kirsch, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    A. Das, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    L. Garrity-Ryan, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    J. N. Steenbergen, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    A. Manley, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    P. Eckburg, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    S. Villano, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    E. Tzanis, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    P. McGovern, Paratek Pharmaceuticals: Employee and Shareholder , Salary

    E. Loh, Paratek Pharmaceuticals: Board Member , Employee and Shareholder , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.