Achaogen Inc., www.achaogen.com a late-stage biopharmaceutical company addressing multi-drug resistant gram-negative infections located in San Francisco, received a contract from the Biomedical Advanced Research and Development Authority (BARDA) www.phe.gov/barda within HHS, to support the development of C-Scape, a product candidate under development to treat serious bacterial infections.
The BARDA contract was awarded to Achaogen under BARDA’s Antibacterial program and includes a nine month period with committed funding for $12 million. Subsequent option periods if exercised would further support Phase 3 trial, manufacturing, nonclinical studies. The preparation of regulatory filings for FDA approval would bring the total value of the award to $18 million.
BARDA provides an integrated portfolio approach to advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergencies. These emergencies may be caused by chemical, biological, radiological, nuclear threats, pandemic influenza, emerging infectious diseases, and antimicrobial resistant pathogens
“Combating antibiotic-resistant infections is fundamental to U.S. biodefense,” explained BARDA Director Rick Bright, PhD. “Long hospitalizations may be likely after a bioterrorism attack that could leave people open to secondary drug-resistant infections. This means that if the U.S. is to be prepared for bioterrorism, we need to have effective products available to treat antibiotic resistant infections.”
Under the $12 million 9 month contract to Achaogen, BARDA will support nonclinical studies, manufacturing and preparatory activities for a Phase 3 clinical trial of C-scape used to treat Complicated Urinary Tract Infections (cUTI).
Bacteria can cause cUTIs to become resistant to other oral antibiotics, therefore, practitioners increasingly rely on antibiotics to be administered intravenously as a last resort to treat patients with infections.
By developing alternative antibiotics such as C-Scape, doctors could rely less often on last resort antibiotics which would give bacteria less opportunity to develop resistance to these drugs and as a result, prolong the drugs’ effectiveness.