Breakthroughs Blog: NTDs

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 phase IV observational study will test whether a novel approach to managing severe malaria, involving interim treatment with rectal artesunate, could address the challenge of treating those with severe cases in isolated rural settings far from a health facility. In the study, patients will be treated with artesunate rectal capsules at the community level and evaluated for clinical outcomes and then will receive follow up treatment with oral artemisinin-based combination therapies once they are well enough to swallow the medicine. The study, led by the newly created Severe Malaria treatment with Rectal artesunate and Arteminisin-based Combination Therapy [in remote settings] (SEMA ReACT) consortium, is intended to generate evidence to inform gaps in guidance on how to approach treatment when it is not feasible to transfer severely ill patients in timely manner to high-level health facilities as current guidance recommends.The results from a new study coordinated by the Drugs for Neglected Diseases initiative (DNDi), the Japanese pharmaceutical company Eisai, and the Mycetoma Research Center in Khartoum found that the oral drug fosravuconazole is up to 85 percent effective in treating the neglected tropical disease mycetoma and has no side effects. Currently, mycetoma is treated with itraconazole, a drug which needs to be taken with food four times a day for a year, has a myriad of side effects, is expensive, and is not available in all endemic countries. In contrast, fosravuconazole, only needs to be taken once a day without food, is inexpensive, and already widely used to treat fungal nail infections—factors that enhance its suitability for widespread use in low-resource settings.The Global Antibiotic Research & Development Partnership (GARDP) has been awarded around $3.07 million from the Research Investment for Global Health Technology Foundation to support an international clinical trial to evaluate three novel antibiotic regimens for neonatal sepsis. This infection affects over 3 million newborns every year, most of whom live in low- and middle-income countries. The trial, run by GARP and partners, is underway in Kenya and South Africa and will expand to more countries next year. The funding will also enable GARDP to collaborate with South Korean Jeil Pharma to explore options to optimize the manufacturing and approval of the novel antibiotics included in the regimens under study to ensure affordable prices and stable supplies of the drugs.

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. Johnson & Johnson on Friday presented new data showing that its pill for dengue fever appeared to protect against a form of the virus in a small human challenge trial done with the Johns Hopkins School of Public Health, providing hope for the first-ever specific treatment for dengue, which is a growing threat around the world due to climate change. The pill, which is the first-ever drug to show antiviral activity against dengue, will also be tested as a treatment method. If the drug is successful in larger-scale trials, ensuring access to the new drug in low- and middle-income countries —especially as the threat of dengue rises in high-income countries alike—will be essential to effectively tackle the disease around the world.The Sabin Vaccine Institute has launched a phase 2 clinical trial for its vaccine candidate against Marburg virus, a lethal filovirus for which there are currently no vaccines or antiviral treatments approved. The trial will take place in Kampala, Uganda, which has experienced various Marburg outbreaks in the past few decades. The single-dose candidate was previously found to be safe and elicit rapid and robust immune responses in phase 1 clinical and non-clinical studies. The ChAd3 platform, which forms the basis of the Marburg vaccine candidate, also undergirds Sabin's Sudan ebolavirus vaccine candidate, which recently received US funding for phase 2 clinical trials. The need for a vaccine against both deadly diseases has been brought to the fore by recent outbreaks.Last week, Gilead Sciences Inc. announced PURPOSE 5, the first phase 2 clinical trial to evaluate an investigational, long-acting HIV prevention option in Europe. Lenacapavir for HIV prevention, compared with a currently used drug combination, could offer a fewer-dose, long-acting solution to individuals who could benefit from pre-exposure prophylaxis (PrEP). Lenacapavir, which can be administered as a twice-yearly injection, is currently approved in combination with other antiretrovirals for HIV treatment in people with multidrug-resistant HIV-1 infection. The study has an intentional focus on recruiting participants who are disproportionately affected by HIV and often underrepresented in clinical trials, given the importance of making available a variety of HIV prevention methods to meet the diverse needs of those who could benefit from PrEP.

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. Scientists have discovered that a naturally occurring strain of bacteria could help reduce the transmission of malaria by stopping the development of parasites in a mosquito’s gut. The bacteria, TC1, was found by chance when GSK scientists noticed that one of their mosquito colonies had stopped becoming infected with malaria parasites and later identified TC1 as the cause. Researchers have since observed that the bacteria works by secreting a small molecule, called harmane, which inhibits the parasite’s growth and that can be ingested by mosquitoes if mixed with sugar or absorbed by contact, opening the possibility for it to be used as an abatement tool. A recent study found that the bacteria can reduce a mosquito’s parasitic load by up to 73 percent, and trials in Burkina Faso are ongoing to assess the intervention’s effectiveness and safety in real-world settings.An international team of researchers has identified a genetic variant among some people of African ancestry that is associated with them having naturally lower viral loads of HIV—thereby slowing their illness progression and lowering the risk of them transmitting the virus. According to the researchers, this is the first new genetic variant related to HIV infection discovered within the last nearly 30 years. Between 4 to 13 percent of people of African origin are thought to carry this variant, which was discovered through an analysis of the DNA of almost 4,000 people of African ancestry infected with HIV-1. The scientists now intend to continue studies to more fully understand how exactly this variant impacts HIV replication.Health experts are warning that dengue poses a danger to pregnant women, as new research has found that the disease can cause serious health complications for both mothers and their unborn babies. A recent study from the University of Surrey found that mild infection can make a pregnant individual 77 percent more likely to give birth before 32 weeks and can more than double the risk of the child being born with extremely low birth weight, which can affect brain development. This work builds on prior research that found pregnant women are three to four times more likely to die after becoming infected and 450 times more likely if their infection progresses into dengue hemorrhagic fever. There are currently no specific treatments for dengue, and existing vaccines are not recommended for pregnant women.

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 week, the US Food and Drug Administration’s (FDA’s) scientific advisers recommended that the next round of COVID-19 vaccines include only the newest variants that have become dominant worldwide, the XBB strains of Omicron, echoing recommendations from the World Health Organization’s vaccine advisers and European regulators. After the FDA makes the final decision, vaccine developers say updated shots could be available within months. The recommendation is based on the idea that the XBB variants are different enough from each other to push the immune system to make more diverse, cross-protective antibodies as opposed to keeping the original strain in the shot, which can cause people’s immune systems to respond more strongly to that strain because of previous, repeated exposure rather than the new strains included in the dose.Researchers at the University of California San Francisco and the National Institute of Biological Standards and Control in the United Kingdom have developed two novel oral polio vaccines, the first new vaccines for polio in 50 years. The vaccines are made from weakened poliovirus that has been genetically engineered to reduce the development of mutations to the active form of the virus, which have been a major challenge of oral polio vaccines, leading to outbreaks of vaccine-derived polio even in countries where the disease was previously believed to have been eliminated. To address those outbreaks as well as uneven vaccination rates worldwide that have led to the continued circulation of the virus, the new vaccines can hopefully be part of the World Health Organization’s most recent push to eradicate polio globally.A phase 3 trial recently published in The Lancet found that Valneva’s FLA1553 vaccine candidate for chikungunya disease was generally well-tolerated and produced an immune response in 99 percent of study participants in chikungunya-endemic regions. There are currently no approved vaccines or effective antiviral treatments for the disease caused by chikungunya infection. The vaccine developers hope that this candidate could become the first vaccine available for people living in as well as travelers to chikungunya-endemic regions or regions at risk of an outbreak. The vaccine could become even more important as climate change is expected to drive the global spread of mosquitoes—and therefore mosquito-borne viruses like chikungunya—to new areas.