Achaogen Announces Positive Top-Line Results from First Clinical Trial of Orally-Administered Antibacterial Candidate C-Scape
January 03, 2018 at 01:07 pm EST
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Achaogen, Inc. announced positive top-line results from its Phase 1 clinical study of C-Scape. C-Scape was well tolerated across all doses studied in the Phase 1 trial, with no drug-drug interaction between the previously approved compounds when dosed in combination. The Company also announced that C-Scape is an oral combination of ceftibuten, an approved third generation cephalosporin, and clavulanate, an approved beta-lactamase inhibitor. C-Scape is the Company's second antibacterial candidate being developed for MDR gram-negative infections and has been awarded Qualified Infectious Disease Product (QIDP) status by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections (cUTI), which provides incentives for new antibiotic treatments, including priority review and additional market exclusivity. The positive top-line results from this first-in-human clinical trial for C-Scape are supportive of further evaluation and continue to plan for Phase 3 in 2018. FDA has previously indicated that a single Phase 3 study in cUTI, if successful, would be sufficient for licensure, and plan to meet with the FDA in early 2018 to seek agreement on the details of development plan,' said Kenneth Hillan, M.B. Ch.B., Achaogen's President, R&D. 'Given the need for additional oral antibiotic options for infections due to ESBL-producing Enterobacteriaceae, plan to pursue a 505(b)(2) development pathway to take advantage of the development studies performed on ceftibuten and clavulanate, the two previously approved component drugs of C-Scape.
Achaogen, Inc. is a late-stage biopharmaceutical company. The Company is engaged in the discovery, development and commercialization of antibacterial treatments against multi-drug resistant (MDR) gram-negative infections. The Company is involved in researching and developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections, including complicated urinary tract infection (cUTI), blood stream infections and other infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). Plazomicin is an intravenous aminoglycoside antibiotic. The Company has developed plazomicin by chemically modifying sisomicin, a naturally occurring aminoglycoside, in order to overcome common aminoglycoside resistance mechanisms. The Company has a portfolio of small molecule and antibody programs. The Company's Early Development programs include C-Scape and LpxC.