Eravacycline: Interim Phase III data

Interim data from 143 patients with cUTI in the lead-in portion of the 2-part, double-blind, double-dummy, international Phase III IGNITE 2 trial showed that both IV-to-oral dosing regimens of eravacycline compared "favorably" to levofloxacin on the FDA- and EMA-defined primary endpoints. Tetraphase said the lead-in portion was not designed to show statistical significance.

The proportion of patients in the MITT population who achieved microbiological eradication and clinical cure at the TOC visit 6-8 days post-treatment, the FDA-defined primary endpoint, was 70.8% for the IV-to-oral 200 mg eravacycline arm and 64.3% for the IV-to-oral 250 mg eravacycline arm vs. 52.2% for levofloxacin. Additionally, the proportion of patients in the MITT and microbiologically evaluable populations who achieved microbiological eradication at the TOC visit, the EMA-defined primary endpoint, was 75% for the IV-to-oral 200 mg eravacycline arm and 64.3% for the IV-to-oral 250 mg eravacycline arm vs. 56.5% for levofloxacin. ...