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Last week, the Global Antibiotic Research & Development Partnership (GARDP) and Debiopharm announced a new partnership to advance the development of Debio1453, a novel, first-in-class antibiotic targeting Neisseria gonorrhoeae, as rising cases and the continued spread of multidrug-resistant strains have turned gonorrhea into a growing health challenge globally. Almost all the antibiotics used to treat gonorrhea caused by N. gonorrhoeae have been rendered ineffective due to antimicrobial resistance, with the bacteria now beginning to develop resistance to the last remaining effective treatment. If successful, this drug candidate could help revive the critically lacking pipeline of new antibiotics, one of many new drugs that will be needed to ensure that innovation can outpace the rapid emergence of antibiotic resistance.  Sedia Biosciences announced last week that the World Health Organization (WHO) has granted prequalification status for its rapid, oral HIV test, enabling global procurers to buy the test and ensure widespread access to the technology. The single-use test, which detects antibodies to HIV-1 and HIV-2 in as little as 20 minutes, is intended for health care providers to be able to use at the point of care in resource-limited settings. Beyond its rapid readout time, the test is less invasive, complicated, and painful than blood testing because it uses oral fluid (saliva), making it simpler and more tolerable for patients. With support from the Coalition for Epidemic Preparedness Innovations (CEPI), the Serum Institute of India and the University of Oxford are partnering to create the largest-ever reserve of an investigational vaccine for Rift Valley fever, against the backdrop of a deadly ongoing outbreak and the threat of future outbreaks of the disease, for which there are no licensed human vaccines. The Serum Institute will manufacture up to 100,000 doses of the University of Oxford’s ChAdOx1 RVF candidate, which is among the most advanced investigational vaccine candidates in the pipeline. Ten thousand doses are set to be used in a planned clinical trial of the candidate in outbreak-affected areas, while the remaining doses will serve as a reserve available for clinical testing during future outbreaks. 

GSK has shared the results of two highly anticipated Phase 3 studies investigating its potential “functional cure” for chronic hepatitis B, which affects more than 250 million people worldwide and is a leading cause of liver cancer. The drug bepirovirsen was found to be safe and more effective than the current standard of care in the studies, which included more than 1,800 patients across 29 countries. Bepirovirsen was also found to be capable of achieving a “functional cure,” defined in the studies as no hepatitis B surface antigens (a marker of active infection) detectable in the blood and no detectable genetic material from the virus for at least 24 weeks after treatment ends. The drug, if successfully approved, has the potential to transform treatment for people with chronic hepatitis B. Last week, IAVI announced that the first doses of experimental HIV vaccine antigens were administered in a Phase 1 trial designed to advance a new strategy for HIV vaccine development. Researchers from IAVI and Scripps Research are investigating the hypothesis that highly specialized vaccine immunogens, delivered in a specific sequence, can target critical cells in the immune system and train them to produce broadly neutralizing antibodies against HIV, which scientists widely agree could provide broad protection against the virus. The trial will take place at six clinical sites in South Africa, carried out by a group of African clinical research centers. A team of researchers led by the University of Virginia has shared findings that could transform the treatment of sepsis, the leading global cause of death, in Africa. With a research grant from the US National Institutes of Health, the scientists followed patients with HIV-related sepsis in eastern Africa for five years. They found that the most common cause of sepsis was tuberculosis and that immediate treatment, even before tuberculosis diagnosis, significantly improved survival rates. The findings show that this strategy of immediate tuberculosis treatment could save lives, as well as underline the need for more accurate rapid diagnostic tests for tuberculosis. 

A recent article explores how artificial intelligence (AI) could revolutionize the development of RNA drugs, which have emerged as a promising tool across health areas, from oncology to preventive vaccines. RNA-based therapies have demonstrated higher success rates than traditional pharmaceuticals and are associated with lower costs and much quicker drug discovery timelines. AI could help address current limitations of the technology by enabling faster and more accurate RNA target identification and expediting the testing of promising drug candidates, also leading to cost savings.  The World Health Organization (WHO) recently announced the prequalification of two rapid antigen tests for SARS-CoV-2, the virus that causes COVID-19, helping improve diagnostics access worldwide as the virus continues to circulate globally. The SD Biosensor Standard Q COVID-19 Ag Test and the Acon Biotech Flowflex SARS-CoV-2 Antigen Rapid Test were previously listed under the WHO’s emergency use listing. Their new designation makes them the first rapid antigen tests for SARS-CoV-2 to achieve WHO prequalification. This decision makes them eligible for procurement by United Nations agencies, global health partners, and other international stakeholders, helping ensure access to rapid, reliable diagnostic testing in low- and middle-income countries. A research team has used an innovative robotic system to develop a possible antibiotic candidate for priority bacterial threats, as the global danger of antimicrobial resistance continues to rise. Specifically, the researchers used the technology to rapidly screen more than 700 complex compounds in just one week, identifying a promising antibiotic candidate that demonstrated high effectiveness against bacteria, including strains similar to the deadly MRSA, while remaining non-toxic to human cells, suggesting it is a strong candidate for further drug development. The new process, which utilizes robotics and “click” chemistry, shows potential as a new method to expedite the typically slow drug discovery process. 

Last week, Moderna announced that it has received an award from the Coalition for Epidemic Preparedness Innovations (CEPI) for up to $54.3 million to support ongoing development of its bird flu mRNA vaccine candidate, after US government backing was cancelled earlier this year. There are currently no vaccines available specifically for bird flu, as the virus continues its worrying spread among animal populations in the United States and globally. A vaccine, especially one using the mRNA platform known for its speed and adaptability, could play a crucial role in curbing a future outbreak in humans with pandemic potential.  A research team led by the Australian Peter Doherty Institute for Infection and Immunity has identified a tool that can detect emerging hotspots for Buruli ulcer years before human infections occur, as the serious bacterial skin infection continues to spread across Australia and endures in other regions around the world. The infection has a long and variable incubation period, making it hard to identify when and where patients were exposed. The researchers tracked the excreta of possums, who have small ranges, making the presence of the bacterium that cause the infection in their excreta a likely sign that it is present locally. Then, they used DNA sequencing to compare the bacterial genomes of possum-derived and human-derived infections, finding where they overlapped to identify areas where human infections could occur. The method aims to allow public health authorities to implement targeted interventions early on, far before human cases occur. Two new studies looking at preventive RSV vaccines and drugs found that that their effectiveness waned over time, suggesting that boosters may be needed to ensure long-lasting protection, as RSV continues to pose a growing seasonal challenge, especially for older adults and infants. The first study found that one dose of the Abrysvo RSV vaccine was highly effective at preventing infections and reducing hospital, emergency department, and intensive care unit admissions in US veterans 60 and older, but this protection decreased over time, with the reductions most notable for immunocompromised individuals. A second study found that the long-acting monoclonal antibody nirsevimab was highly effective in hospitalized European children two years or younger for one season, but after that, protection waned. Both studies demonstrate the real-world impact of these crucial tools and suggest that boosters could be implemented to ensure long-lasting protection, especially for higher-risk individuals.