Federal health officials will invest nearly $100 million to develop a new antibiotic that can treat drug-resistant "superbugs" for which there are currently few or no treatment options.
HHS will collaborate with the Defense Department and Malvern, Pa.-based drugmaker VenatoRx Pharmaceuticals on the company's compound VNRX-5133. When combined with the intravenous antibiotic cefepime, the compound might combat bacteria that is resistant to currently available antibiotics, the agencies said Monday.
The six-year project will focus on treating gram-negative bacteria, which are multidrug-resistant and among the most difficult infections to treat. These infections have become increasingly common in healthcare settings in recent years through pneumonia, bloodstream and surgical site infections.
HHS will provide VenatoRx up to $20 million over two years under a cost-sharing agreement. The company will pursue Food and Drug Administration approval to treat complicated urinary tract infections caused by gram-negative bacteria. The cost-sharing contract might be extended to up to six years for up to $86.8 million in funding.
The Defense Department's Defense Threat Reduction Agency will put in $10 million to fund nonclinical costs related to the project, including studies to test the combination's efficacy against bioterrorism threats.
"Developing new antibiotics that represent an improvement over standard of care antibiotics is essential to national health security and global health efforts to combat antibiotic-resistant infections," said Rick Bright, director of HHS' Biomedical Advanced Research and Development Authority, in a statement. "This unique public-private partnership will focus on adding a new tool to healthcare providers' toolkits and to help them save lives in an incident involving some of the serious bioterrorism threats our country faces."
At least 2 million people annually contract antibiotic-resistant infections in the U.S. at a cost of $35 billion per year, according to the Centers for Disease Control and Prevention.
Antimicrobial resistance has become a growing public health concern as an increasing number of pharmaceutical companies have stopped developing antibiotics, citing the financial risks.
VenatoRx Chief Operating Officer Ezra Felker said the company plans to begin FDA Phase 3 clinical studies for the combination drug within weeks. The federal funding will help the company address the economic challenges associated with antibiotic development.
"We all feel that antibiotics are a critical need in the healthcare system, and especially in today's environment where there is so little investment occurring from smaller companies, it's important for the smaller companies to step up and take the mantle and develop the next generation of antibiotics," Felker said.
The decline in the pipeline of newer antibiotics coupled with the continued overuse of existing drugs has led to a dwindling number of treatments that are effective against the worst infections.
Healthcare providers more frequently turn to antibiotics that had long been considered treatment of last resort, which experts say will make those drugs less effective as greater exposure to such therapies will eventually cause pathogens to become resistant.
By 2050, up to 10 million deaths worldwide may be caused by drug-resistant infections, according to a United Nations report released in April. More than 2 million of those deaths would occur in wealthy nations.
Many stakeholders have called for changes to antibiotic reimbursement to drugmakers to create incentives for development and prevent overuse of the new drugs. It's a challenge that weighs on Felker.
"We have got to find a balance between minimizing the potential for overuse but yet rewarding companies like us that are investing time and energy and resources in developing life-saving treatments," Felker said.
