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Background: Eravacycline (ERV) is a novel fluorocycline being developed for the treatment of serious infections, including those caused by MDR pathogens. Multivariate analysis of data from a phase 3 study of ERV in complicated urinary tract infection (IGNITE2) indicated that the oral dosing component drove the overall study results in which the primary efficacy endpoint was not achieved. We investigated ERV exposure following oral dosing under conditions of the phase 3 study. Methods: This was a two-period cross-over study in healthy subjects. In both periods subjects received ERV: 3 doses of 1.5 mg/kg IV q24h followed by 9 doses of 200 mg oral q12h with the first oral dose 12h after the last IV dose. In one period (fasted) subjects were fasted at least 4h prior to oral doses and in the other period (fed) the subjects were fed as in the previous phase 3 study; 2h prior to dosing. Plasma and 24h urine were collected on Days 1, 3 and 7. Results: The following exposures [mean(%CV)] were observed: Introduction Eravacycline (ERV) is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious and life-threatening infections, including those caused by multidrug-resistant pathogens. In a recent Phase 3 study (IGNITE2) examining the efficacy and safety of ERV administered as IV-to-oral treatment for cUTI, ERV did not meet the primary efficacy endpoint. Post-hoc analyses support the conclusion that overall study results were driven by the underperformance of the oral formulation of ERV under the experimental conditions of the study.1-3 The purpose of this study was to further investigate IV-to-oral formulations of ERV under fed and fasted conditions to better understand the results from the IGNITE2 study and guide further development of ERV oral formulations. Results

Impact of Meal Timing on Eravacycline Exposure During the Oral Portion of an IV to Oral Transition Dosing Regimen