UCSF

Phase-IIA Early Bactericidal Activity (EBA) Studies

The Savic Lab is currently working to integrate in vivo drug effects with immune function data from murine PK/PD models, clinical PK models, and translational factors to predict bactericidal activity in phase-IIA early bactericidal activity studies. Phase-IIA early bactericidal activity (EBA) studies are used to quantify the short-term efficacy (typically over the span of two to 14 days) of investigational drugs in humans. While this may seem an intuitive first step in assessing efficacy, the durations of these trials are not long enough to provide for the assessment of sterilizing activity, and they have never been linked to long-term clinical efficacy or outcomes. Furthermore, EBA studies provide little information for later-phase trials, which assess drugs in combinations over longer treatment periods. By using a translational model to predict results of EBA studies, we re-assess short term efficacy of monotherapy and can speed drug development through this Phase.