Achaogen, Inc. announced that it has dosed the first patient with C-Scape in a Phase 1 clinical pharmacology, dosing and safety study. C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, is the company’s second antibacterial candidate being developed for MDR gram-negative infections. With the C-Scape program, Achaogen plans for a rapid development and regulatory approach that leverages a 505(b)(2) path that, if the Phase 1 is successful, supports the initiation of a single pivotal Phase 3 trial in the first half of 2018. C-Scape has been awarded Qualified Infectious Disease Product (QIDP) status by FDA for the treatment of cUTI, including acute pyelonephritis (AP). QIDP designation provides incentives for new antibiotic treatments, including priority review and additional market exclusivity. The Company’s preclinical studies have confirmed C-Scape’s potent in vitro microbiologic activity against ESBL-producing Enterobacteriaceae and its potential to achieve efficacious exposures with an oral dosing regimen.