- Results from a Phase 1 clinical trial assessing the safety, tolerability and pharmacokinetics of Achaogen's (NASDAQ:AKAO) antibiotic candidate C-Scape showed that it was safe and well-tolerated across all doses with no drug-drug interactions.
- QIDP-tagged C-Scape is an oral combination of ceftibuten, a third-generation cephalosporin, and clavulanate, a beta-lactamase inhibitor. Both are already approved in the U.S. as monotherapies.
- The company says it plans to meet with the FDA this quarter to clarify the design of a Phase 3 study, expected to commence later this year. The agency previously stated that a single successful late-stage study in complex urinary tract infections (cUTI) should be sufficient for approval.
- Shares are up 9% premarket.
- Previously: FDA accepts Achaogen's marketing application for plazomicin for cUTI, action date June 25; shares ahead 9% premarket (Jan. 2)
- Now read: 2018 Week 1 Breakout Forecast: Short-Term Picks To Give You An Edge
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