Breakthroughs Blog: Medicines

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A study published last week and presented at the American Society of Tropical Medicine & Hygiene’s (ASTMH’s) annual meeting found that the malaria parasite is acquiring partial resistance to artemisinin, a key drug used to treat children with severe malaria, meaning that infection takes longer to clear and is not always being completely cleared by the drug. The researchers found partial resistance to the drug in 11 of the 100 children treated in the study, with 10 patients “cured” of severe malaria having a resurgence of the same strain within a month of the original infection, implying that the first treatment did not fully eliminate the parasite. More studies are needed to determine how widespread artemisinin resistance is in Africa. Still, the findings underscore the need for novel or alternative drugs to be used in the treatment of severe malariaThe US Centers for Disease Control and Prevention (CDC) has awarded Alveo Technologies a contract to develop a molecular assay to detect and differentiate the H5 subtype of avian influenza A from seasonable influenza A and B viruses in humans, as the ongoing spread of H5N1 in animals across the United States raises concerns about a new pandemic as regular flu season looms. Currently, only CDC and US state and jurisdictional public health labs have access to CDC’s molecular test to detect the H5 strain of influenza A, which could lead to delays in diagnosis or treatment if we start to see transmission between humans. Decentralized testing capabilities at the point of care will be needed to ensure any spread between humans is detected and controlled quickly to avoid another pandemic, as well as to reduce the burden on centralized laboratories.  Last week, the endTB consortium announced the completion of the endTB-Q trial, the first Phase 3 randomized controlled trial to exclusively enroll people with pre-extensively drug-resistant tuberculosis (pre-XDR-TB), with preliminary results demonstrating that a shorter, less toxic treatment strategy of four drugs achieved high cure rates overall, especially in those with non-severe cases of TB disease. Pre-XDR-TB has historically been treated with toxic regimens that last up to two years, are hard to tolerate, and are not very effective. This study tested a personalized medicine strategy, with disease severity and early treatment response used to decide between a six- or nine-month treatment regimen. The study included participants from India, Kazakhstan, Lesotho, Pakistan, Peru, and Vietnam.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A new, first-of-its-kind trial will assess the safety and immunogenicity of Bavarian Nordic’s MVA-BN mpox vaccine in pregnant and breastfeeding women and infants under two years old, two populations at risk of severe complications from mpox but not currently eligible for vaccination. MVA-BN is the only vaccine for mpox prequalified by the World Health Organization and is currently approved for healthy adults and adolescents, but additional data from this trial could help expand access for additional key populations amid the ongoing mpox outbreak. The trial, which will start early next year, is jointly funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and Global Health EDCTP3.Researchers from the University of Glasgow have developed a new drug that could help combat the spread of treatment-resistant malaria, as the disease continues to kill more than 600,000 people every year and Plasmodium falciparum, a mosquito vector that spreads malaria, grows increasingly resistant to artemisinin, the frontline malaria treatment. The drug, adapted from a cancer treatment approach, works by permanently disabling a protein that P. falciparum uses to duplicate itself in humans. The researchers behind the drug think it could be more effective than current drugs at all stages of malaria infection, potentially with only one dose.A research team from the University of California, Santa Barbara has found a way to potentially reduce the spread of mosquito-borne diseases by disrupting male mosquitoes’ ability to hear, which is essential for them to mate and breed. Male mosquitoes rely on the sound of female mosquitoes’ wingbeats in order to find and mate with them. By altering a genetic pathway that male mosquitoes use for hearing, the researchers were able to stop them mating entirely, preventing female mosquitoes, the ones that spread diseases to humans, from having babies and reducing overall mosquito populations. Specifically, the researchers studied Aedes aegypti mosquitoes, which spread diseases including dengue, yellow fever, and Zika.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A team led by US Food and Drug Administration researchers last week published findings suggesting that three vaccines, already approved and stored in the Strategic National Stockpile, targeting earlier H5N1 clades that circulated in the early 2000s could provide some cross-neutralizing antibodies against the currently circulating 2.3.4.4b clade, which continues to infect dairy herds and some farm workers across the United States. Federal officials are already implementing a plan to produce 4.8 million doses of an updated vaccine targeting the current clade, with the first doses expected to be delivered this month, but, before being administered to people, the shots would still need to get regulatory approval. These new study results offer hope that the old vaccines could provide some protection if there is a need to start vaccinating humans before the updated vaccines become available.Recently published results from a Phase 2 clinical trial conducted in Sudan by the Drugs for Neglected Diseases initiative and the Institute of Endemic Diseases at the University of Khartoum found promising results for a new and improved treatment for people with post-kala-azar dermal leishmaniasis (PKDL), a serious condition that can develop after treatment for visceral leishmaniasis. The current treatment for PKDL is an injectable drug given for two to three months, which can cause life-threatening toxicity and must be administered under close supervision in a hospital. The new treatment is safer, shorter, cheaper, more effective, and more patient-friendly, only requiring patients to be admitted to the hospital for 14 days followed by an oral treatment that can be completed at home, offering hope of a new and improved tool for PDKL for affected populations, like in Sudan where nearly 20 percent of patients treated for visceral leishmaniasis will develop PKDL within six months post-treatment, the highest rate worldwide.The Sabin Vaccine Institute and the Makerere University Water Reed Project recently launched a Phase 2 clinical trial testing Sabin's vaccine against Sudan ebolavirus, which can cause deadly disease, as seen in the recent outbreak in Uganda that ended only last year. Although Sabin’s vaccine was one of three candidates chosen to be included in a trial during the outbreak, the outbreak ended before the trial could begin. The vaccine candidate, which is based on the same platform as Sabin’s Marburg vaccine candidate that is already undergoing its own Phase 2 trial, was found to be safe and elicit rapid, robust, and long-lasting immune responses in Phase 1 clinical and nonclinical studies. There is currently no approved vaccine for Sudan ebolavirus.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last Wednesday, the World Health Organization (WHO) announced that it had prequalified an at-home, over-the-counter assay for hepatitis C virus (HCV), the first self-test to be prequalified for HCV, which causes an estimated 1 million new infections globally each year. The prequalification of the assay, manufactured by OraSure Technologies, extends the 2017 prequalification of the company’s HCV test for professional use. Self-testing is recommended to complement existing testing services based on evidence demonstrating that it increases access to and uptake of services. The prequalification status will hopefully enable procurement in low- and middle-income countries, expanding access to HCV testing and treatment services and helping to contribute to the global goal of HCV elimination.The Safety of Antimalarials in First Trimester consortium, made up of scientific and social research experts on malaria in pregnancy has kicked off preparation for the first-ever Phase 3b clinical trial testing the efficacy and safety of antimalarials in women in their first trimester of pregnancy, which will be cosponsored by Medicines for Malaria Venture and the Liverpool School of Tropical Medicine. Pregnant women are typically excluded from clinical trials out of fear of causing harm, leaving few medicines for malaria treatment and no medicines for prevention available for women in their first trimester despite the significant health risks associated with malaria in pregnancy. The data from this trial could enable pregnant women and all women of childbearing age to safely take these antimalarial medicines without risk of causing harm, as well as support the design of future trials targeting other infectious diseases affecting pregnant women in low- and middle-income countries.  New research has led to the discovery of a potent adjuvant, PVP-037, that could induce a greater, more durable, and broader immune response to vaccines. Adjuvants are compounds that enhance the immune response, which are key to vaccine development, particularly for inactivated virus vaccines. Researchers identified the compound by screening a library of more than 200,000 small molecules found in human immune cells. In mice, an optimized form of the adjuvant boosted antibodies against flu and SARS-CoV-2 when given alongside disease-causing antigens. The compound is stable, easy to work with, and can be formulated in most drug delivery systems, which would make it easier to integrate it into vaccine development. Further research will be needed to study how the adjuvant performs in the presence of actual pathogens, assess its impact on the durability of immune responses, and test whether it works across age groups.