Option Funding Focused on Phase 3 EPIC Registration Trial of Plazomicin in cUTI; Company Expects
Top-Line EPIC Study Results in the First Quarter of 2017
SOUTH SAN FRANCISCO, Calif., June 02, 2016 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has been awarded $20 million for an additional option, Option 3, on its existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of plazomicin. Plazomicin is the Company’s lead product candidate being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
The BARDA contract was originally awarded to Achaogen under BARDA’s Broad Spectrum Antimicrobials program in August 2010. The original contract consisted of a base award as well as three options that, effective today, have all been exercised. With the granting of this last option, the unspent funding currently committed under the contract with BARDA now totals approximately $41 million. The funding from Option 3 is focused on the Phase 3 pivotal clinical trial of plazomicin, the EPIC study, in complicated urinary tract infections (cUTI). Achaogen expects to release top-line results from the EPIC study in the first quarter of 2017, and plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2017.
“We appreciate BARDA’s overall support of the plazomicin program, including this additional financial support for the Phase 3 EPIC study,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “Multi-drug resistant gram-negative infections continue to be a serious public health threat, especially given the high mortality rates associated with CRE infections.”
In a separate press release, the Company announced today that it has entered into an agreement to sell shares of its common stock and warrants to purchase shares of common stock for aggregate gross proceeds of approximately $25 million in a private placement to a syndicate of new investors. In addition to this equity financing, the Company plans to draw $10 million in additional debt under its existing loan agreement with Solar Capital Ltd.
About the EPIC Study
EPIC (Evaluating plazomicin in cUTI) is a multi-national, randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI) including acute pyelonephritis (AP), which is expected to create a substantial opportunity for plazomicin to address unmet medical needs arising from multi-drug resistant (MDR) infections. EPIC is expected to serve as a single pivotal trial supporting a New Drug Application (NDA) for plazomicin in the United States.
About Achaogen
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections.
For more information, please visit www.achaogen.com.
