Achaogen has reported positive results from a Phase l clinical trial of C-Scape for treatment of multi-drug resistant (MDR) gram-negative infections.
The double-blind, randomised, placebo-controlled, parallel group study evaluated the safety, tolerability and clinical pharmacology of C-Scape, which is an oral combination of ceftibuten, an approved third-generation cephalosporin, and clavulanate, an approved beta-lactamase inhibitor.
During the trial, C-Scape was administered orally in 41 healthy subjects.
The trial has found that the combination of ceftibuten and clavulanate was well-tolerated when administered for 14 days across all dosing regimens tested.
It did not lead to any serious adverse events (SAEs), grade 3 or 4 adverse events, or incidents that would discontinue the study.
Among other results, the trial also showed consistent safety profile with expectations for ceftibuten and clavulanate when administered based on existing product labels.
Achaogen R&D president Kenneth Hillan said: “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 lll in 2018.
“FDA has previously indicated that a single Phase lll 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.
“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.”
Achaogen has previously received qualified infectious disease product (QIDP) status from the US Food and Drug Administration (FDA) for using C-Scape in treating complicated urinary tract infections (cUTI).