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United States : Achaogen Announces Positive Top-Line Results from First Clinical Trial of Orally-Administered Antibacterial Candidate C-Scape.

Achaogen, Inc., a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today 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 we 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 we plan to meet with the FDA in early 2018 to seek agreement on the details of our 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, we 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."

ESBL-producing Enterobacteriaceae are often resistant to currently available oral therapies. The lack of adequate oral therapies leads to hospitalization for intravenous therapy. New oral agents with activity against ESBL-producing organisms are needed to reduce hospitalization and reliance on carbapenems. The ultimate goal of the C-Scape development program would be to treat certain MDR infections in the outpatient and possibly step-down settings.

"There is a tremendous need for orally-administered antibiotics with activity against MDR pathogens, such as ESBL-producing Enterobacteriaceae," said Yoav Golan, M.D., M.S., Tufts Medical Center. "For patients suffering from complicated urinary tract infections due to ESBL-producing Enterobacteriaceae, intravenous carbapenem therapy is often their only treatment option. I would welcome a new oral beta-lactam and beta-lactamase inhibitor combination that would help limit use of carbapenems in these patients."

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Publication:Mena Report
Date:Jan 3, 2018
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