C-Scape: our next clinical candidate, an oral antibacterial to potentially address the growing problem of antimicrobial resistance

C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination, is currently being developed as an antibacterial candidate to address the growing problem of antimicrobial resistance. Achaogen announced the initiation of the C-Scape clinical development program in June 2017 with the start of the Phase 1 clinical study. The goal of the C-Scape clinical development program is to examine the effectiveness of C-Scape for treating patients suffering from complicated urinary tract infections (cUTI) who have lost effective oral treatment options due to multi-drug resistant pathogens such as Extended Spectrum Beta Lactamase (ESBL)-producing Escherichia coli and Klebsiella pneumoniae. If the Phase 1 clinical study is successful, Achaogen plans to initiate a single pivotal Phase 3 clinical trial in patients with cUTI in the first half of 2018.

Approximately 10 to 30 percent of clinical Enterobacteriaceae isolates in the United States and European Union produce ESBLs, rendering them resistant to all beta-lactam antibiotics except for carbapenems. Intravenous carbapenem therapy is considered a “last-line” option, creating an urgent need for a new oral antibiotic option. Preliminary non-clinical studies of C-Scape found potent in vitro microbiology activity against ESBL-producing Enterobacteriaceae and rapid bactericidal activity in time-kill experiments, which when combined with pharmacokinetic models based on clinical beta-lactam/beta-lactamase inhibitor data suggests the potential to achieve efficacious exposures with an oral three times daily dosing regimen.

In January 2017, the FDA awarded C-Scape Qualified Infectious Disease Product (QIDP) status for the treatment of cUTI, including acute pyelonephritis. QIDP designation provides incentives for new antibiotics, including priority review and additional market exclusivity.