Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to US$1.8 million to biotechnology company, Visby Medical, to develop a portable rapid polymerase chain reaction (PCR) diagnostic to detect the presence of the pathogen that causes gonorrhea, Neisseria gonorrhoeae (NG), and its susceptibility to ciprofloxacin, a former frontline oral antibiotic that can no longer treat resistant NG. A rapid result on when ciprofloxacin may be effective could enable physicians to treat gonorrhea patients with confidence, while reserving ceftriaxone, the only antibiotic that remains effective against resistant NG.
Visby Medical is a leading innovator in rapid and accurate PCR testing for sexually transmitted infections (STIs) as well as COVID and the flu. The CARB-X award will help the company drive the next phase of development to meet the urgent challenges facing today's healthcare system.
In addition to the development of a rapid test for NG and susceptibility to ciprofloxacin, funding will support development of a test for NG as well as Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) in men based on urine samples. Currently, Visby Medical provides healthcare professionals with a second generation Sexual Health Test for the three most common STIs in women; the test is 510(k) cleared and has received a CLIA waiver from the U.S. Food and Drug Administration.
Additional CARB-X funding will be awarded in separate phases covering feasibility testing and development of both the antimicrobial resistance and male STI testing uses. Funding will be triggered by the completion of specific project goals. Visby Medical intends to supplement the CARB-X award with additional funding sources.
Gonorrhea is the second most reported bacterial STI. Approximately 82 million people were infected globally in 2020. Patients with gonorrhea can face serious health effects, including pelvic inflammatory disease, chronic pelvic pain, and infertility. If left untreated, gonorrhea can spread to the bloodstream, which can be life threatening, and increase the risk of HIV infection. Since patients do not always exhibit symptoms, reported cases may only capture a fraction of the true burden.
"Following a year-long funding call for diagnostics that aim to identify gonorrhea and determine its susceptibility to antibiotics, Visby Medical joins SpeeDx, making two diagnostic developers in the CARB-X portfolio that focus on this infection," said Erin Duffy, PhD, R&D Chief of CARB-X. "Our goal is to deliver diagnostics that are effective at all levels of the healthcare system. Given the portability of the envisioned Visby Medical PCR platform, which fits in the palm of your hand, we see this as rapidly and highly deployable in low-resourced and hard-to-reach settings. Additionally, for regions where ciprofloxacin remains a viable treatment, the Visby Medical diagnostic gives confidence that the physician is making the correct treatment decision."
The sexually transmitted infections epidemic continues to increase. That is why healthcare providers in ERs, urgent care clinics, community health centers and physicians' offices need accurate and rapid diagnostic tests to enable same-visit, data-driven treatment based on a test result that identifies the pathogen and its antibiotic susceptibility. The CARB-X award will allow Visby Medical to enhance the only instrument-free PCR platform by adding the capacity to detect ciprofloxacin-resistant gonorrhea immediately and at the point-of-care. This has the potential to redefine best practice for patient care, infection control, and antibiotic stewardship."
Gary Schoolnik, MD, Chief Medical Officer of Visby Medical
An estimated 1.27 million people died due to drug-resistant bacterial infections in 2019, a death toll that exceeded HIV/AIDS (864,000) and malaria (643,000) in that same year. CARB-X is building a pipeline of high-value products to prevent, diagnose and treat bacterial infections, including those that have become resistant to antibiotics. CARB-X emphasizes performance characteristics that will allow the broadest use of these products against infections driving the greatest global morbidity and mortality.
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since then, CARB-X has supported 95 R&D projects in 13 countries, and CARB-X product developers have made tremendous progress: 18 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least 9 product developers with active R&D projects have already secured advanced development partnerships which can help support their clinical development after leaving the CARB-X portfolio.
In 2022, CARB-X launched new funding rounds to support R&D projects and fill critical gaps in the antibacterial pipeline. These include oral therapeutics to replace the workhorse antibiotics that are failing; vaccines for neonatal sepsis, which kills 2.5 million infants annually; and oral therapeutics, vaccines and rapid diagnostics for gonorrhea. Visby Medical's diagnostic is the first diagnostic and fourth project to receive a CARB-X award as part of the 2022-2023 funding call. Additional projects are under review, and new product developers will be announced this year. Register for the CARB-X newsletter to learn more about upcoming funding calls that will be announced this year.