HHS and the Defense Department (DOD) on Monday announced a partnership with pharmaceutical company VenatoRx, under which the departments will invest up to $100 million to help develop an antibiotic that can treat antibiotic-resistant superbugs.
Under the partnership, HHS' Office of the Assistant Secretary for Preparedness and Response and DOD's Threat Reduction Agency will provide funding to help develop VenatoRx's compound VNRX-5133. When combined with the antibiotic cefepime, VNRX-5133 might be able to combat gram-negative bacteria, which can be resistant to multiple drugs and treatments. VenatoRx is studying whether the combination therapy could be used to treat drug-resistant hospital-acquired bacterial pneumonia, urinary tract infections (UTIs), and ventilator-associated bacterial pneumonia, as well as potential bioterrorism pathogens.
HHS' Biomedical Advanced Research and Development Authority (BARDA) will give VenatoRx up to $20.7 million in funding over two years under a cost-sharing contract with the company. HHS could choose to extend the contract to up to six years and provide up to $86.8 million in funding toward the project. In addition, DOD's Threat Reduction Agency will provide $10 million toward the project to fund nonclinical costs, including studies to test the drugs' efficacy.
VenatoRx will use the funding to support late-stage clinical testing of the combination drug and to gain FDA's approval for the drug to treat complicated UTIs caused by antibiotic-resistant bacteria.
VenatoRx plans to begin Phase 3 clinical studies for the combination antibiotic within the next few weeks, according to Ezra Felker, the company's COO.
The combination drug could be a step forward in combating antimicrobial resistance, which has become a growing health concern in recent years. According to CDC, more than two million people develop antibiotic-resistant infections per year.
"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 BARDA Director Rick Bright. Bright added that the "public-private partnership" between DOD, HHS, and VenatoRx could help health care providers "save lives in an incident involving some of the serious bioterrorism threats [the United States] faces."
Christopher Burns, co-founder and CEO of VenatoRx, said developing the combination treatment is particularly "critical" now that fewer pharmaceutical companies are developing antibiotics. "The antibiotics industry is experiencing significant commercial and reimbursement headwinds that are collectively driving down valuations and discouraging big pharmaceutical companies from investing in the sector," Burns said.
Similarly, Felker said, "[I]n today's environment where there is so little investment occurring from larger companies, it's important for the larger companies to step up and take the mantle and develop the next generation of antibiotics." Felker added, "We have got to find a balance between minimizing the potential for overuse but yet rewarding companies like [VenatoRx] that are investing time and energy and resources in developing life-saving treatments" (Ross Johnson, Modern Healthcare, 7/22; George, Philadelphia Business Journal, 7/22).