LAUSR

Abstract Background Eravacycline is a novel, fully synthetic fluorocycline antibiotic that was evaluated in three comparator-controlled studies for the treatment of complicated intra-abdominal infections (cIAI). The objective of this analysis was to evaluate the safety profile of eravacycline 1 mg/kg IV q12h for the treatment of cIAI. Methods Pooled data from one phase 2 and two phase 3 (IGNITE1 and IGNITE4) clinical trials in cIAI were analyzed. Patients in the trials were randomized to receive eravacycline 1 mg/kg IV q12h, ertapenem 1 g IV q24h, or meropenem 1 g IV q8h for 4–14 days. Overall treatment-emergent adverse events (TEAEs), serious TEAEs, and laboratory assessments were evaluated. Results Five hundred seventy-six patients were treated with eravacycline 1 mg/kg IV q12h and 547 patients with comparators (ertapenem and meropenem). Demographic and baseline characteristics were similar among the groups. Overall summary and common TEAEs are presented in Table 1. None of the serious TEAEs or those leading to death were related to the study drug. Clinically notable laboratory abnormalities were relatively uncommon and occurred at similar frequencies in eravacycline- and comparator-treated patients.Table 1. Overall Summary of Treatment Emergent Adverse Events—Eravacycline Phases 2 and 3 Clinical Studies Eravacycline 1 mg/kg IV q12h, N = 576, n (%) Comparatorsa, N = 547, n (%) Any TEAEs 217 (37.7) 152 (27.8) Nausea 40 (6.9) 5 (0.9) Vomiting 20 (3.5) 13 (2.4) Diarrhea 13 (2.3) 8 (1.5) Infusion phlebitis 13 (2.3) 1 (0.2) Pyrexia 11 (1.9) 11 (2.0) Anemia 7 (1.2) 12 (2.2) Treatment-related TEAEs 71 (12.3) 20 (3.7) TEAEs leading to discontinuation from study drug 9 (1.6) 12 (2.2) Serious TEAEs 33 (5.7) 33 (6.0) TEAEs leading to death 7 (1.2) 7 (1.3) aComparators include ertapenem 1 g IV q24h and meropenem 1 g IV q8h. Conclusion This pooled analysis demonstrated that eravacycline 1 mg/kg IV q12h was generally well tolerated for the treatment of cIAI when compared with ertapenem and meropenem. Results of the analysis are consistent with those of individual clinical studies and no new safety signals were identified. Disclosures E. Efimova, Tetraphase Pharmaceuticals: Employee, Salary. M. Olesky, Tetraphase Pharmaceuticals: Employee and Shareholder, Salary. S. Izmailyan, Tetraphase Pharmaceuticals: Employee, Salary. L. Tsai, Tetraphase Pharmaceuticals: Employee and Shareholder, Salary.