Achaogen, Inc., a late-stage biopharma company developing antibacterials addressing multi-drug resistant (MDR) gram-negative infections, has been awarded a contract valued at up to $18 million from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of C-Scape, a candidate being developed to treat serious bacterial infections. The BARDA contract includes a nine-month base period with committed funding of $12 million and subsequent option periods that, if exercised, would bring the total value of the award to $18 million.

Achaogen is conducting a Phase I trial to assess the safety, tolerability and clinical pharmacology of C-Scape, and plans for a streamlined development approach that leverages a 505(b)(2) path if the trial is successful and supports the initiation of a Phase III trial in 2018. C-Scape has been awarded Qualified Infectious Disease Product (QIDP) status by FDA for the treatment of cUTI, including acute pyelonephritis (AP). 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.

“We are extremely grateful for BARDA’s support, and validation, of our C-Scape program as we advance this unique candidate through a streamlined development approach with an aim of initiating a pivotal Phase III trial next year,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s chief executive officer. “We believe that C-Scape offers the potential for a much-needed oral therapy to effectively treat infections due to ESBL-producing Enterobacteriaceae, and we look forward to continuing to work with BARDA as they provide critical leadership in the effort to combat multi-drug resistance.”