Tetraphase Pharmaceuticals, a clinical stage biopharmaceutical company, has received a contract worth up to $67 million from the Biomedical Advanced Research and Development Authority (BARDA) for the development of TP-434, a potent new antibiotic effective against multidrug-resistant (MDR) gram-negative pathogens and the lead product candidate in its clinical pipeline. Tetraphase will be working on this contract with New York based CUBRC, Inc.
“BARDA’s award covering the development of TP-434 brings the total federal funding in support of the development of Tetraphase’s antibiotics to more than $100 million,” said Guy Macdonald, president and chief executive officer of Tetraphase. “Tetraphase and CUBRC are proud to play an important role in addressing the global concerns of bio-terrorism and antibiotic resistance via the development of potential solutions to these growing threats to human health.”
The BARDA contract includes pre-clinical efficacy and toxicology studies; clinical studies; manufacturing activities; and associated regulatory activities to position the broad-spectrum antibiotic TP-434 as a potential empiric countermeasure for the treatment of inhalational disease caused by bacillus anthracis, francisella tularensis and yersinia pestis. In parallel, TP-434 is being developed as a potential therapeutic agent for serious hospital infections, including those caused by multidrug-resistant aerobic and/or anaerobic gram-negative and gram-positive pathogens.
The contract includes a 12-month base period with committed funding of $11.5 million and subsequent option periods that, if completed, would bring the total value of the award to approximately $67 million.
TP-434, the lead product candidate in Tetraphase's clinical pipeline, is a potent new antibiotic effective against MDR gram-negative pathogens like escherichia coli and klebsiella pneumoniae. TP-434 is also effective against a broad spectrum of other difficult-to-treat and MDR pathogens, including gram-positive bacteria like methicillin-resistant Staphylococcus aureus (MRSA), anaerobic species like clostridium difficile, and atypical species like legionella that grow inside human cells. TP-434's spectrum and pharmacokinetic properties are consistent with its use as a once-daily monotherapy. Preliminary phase I data have shown that TP-434 also has the potential to be developed as an oral therapy. TP-434 I V is currently in phase II clinical development for cIAI, complicated intra-abdominal infections.
Tetraphase Pharmaceuticals Inc. is developing a portfolio of potent new antibiotics designed to be effective against dangerous, drug-resistant bacteria, including MDR gram-negative pathogens.
CUBRC is an independent not-for-profit scientific corporation that executes research, development, testing and systems integration programmes in medical sciences, chemical and biological defense, public safety and infrastructure, information fusion, command and control, and hypersonics.