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. There is new hope that yaws, a chronic, disfiguring childhood disease, could be eradicated by 2030 with a renewed focus and hopefully, some new tools, especially given the emergence of resistance in the last few years to azithromycin, which has been used as an alternative to penicillin for yaws treatment since 2012. Despite the need for new tools to address the remaining burden of the disease, there are disappointingly few in the pipeline. There is one drug, linezolid, being evaluated that, like azithromycin, is easy to transport and administer, as well as an updated mass community treatment approach with azithromycin. Although the bacteria that causes yaws is tricky to target with a vaccine, ongoing research on a syphilis vaccine that targets the same bacteria that causes yaws could offer cross-protection. With underreported cases also a barrier to eradication, new, robust tests are also a major gap in the tools in our arsenal. The first human trial of a new vaccine against the deadly Nipah virus began last week after the work, which started in 2017, was paused during the COVID-19 pandemic. South Asia faces the greatest burden of Nipah virus, the priority pandemic pathogen that can be fatal in up to 75 percent of cases. There are currently no treatments or vaccines available against Nipah. The new vaccine, ChAdOx1 NipahB, which was developed using the same viral vector vaccine technology as the University of Oxford and AstraZeneca’s COVID-19 vaccine, will be evaluated over the next 18 months in a trial led by the Oxford Vaccine Group and funded by the Coalition for Epidemic Preparedness Innovations (CEPI). The World Health Organization (WHO) recently prequalified the novel oral poliovirus vaccine type 2 (nOPV2), the first prequalification of a vaccine being used under WHO's emergency use listing. nOPV2 was developed by an international consortium, which included GHTC members: Bill & Melinda Gates Foundation and PATH, and is as safe and effective as its predecessor, the oral polio vaccine, but more genetically stable, meaning it is much less likely to lead to vaccine-derived outbreaks. Nearly 1 billion doses of the vaccine have been administered across 35 countries since the rollout began in March 2021, and it has already played a key role in addressing outbreaks of type 2 variant poliovirus. WHO's decision now paves the way for even more countries to receive the vaccine.The Novo Nordisk Foundation, the nonprofit holding of Novo Nordisk and Novozymes, has announced a new grant of $25 million to the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). With this grant, the Novo Nordisk Foundation joins major governments and foundations in supporting the work of CARB-X to accelerate the early-stage development of innovative tools to prevent, diagnose, and treat drug-resistant bacterial infections. Efforts are focused on the most dangerous bacteria, which have been prioritized by the World Health Organization and the US Centers for Disease Control and Prevention, the syndromes with the greatest morbidity and mortality across the world, and the performance characteristics that clinicians and patients need the most. Since 2016, CARB-X has funded 93 projects in 12 countries, with 19 projects having advanced into or completed clinical trials; 12 actively in clinical development, including late-stage clinical trials; and two diagnostic products on the market.  

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 phase 3 trial testing a new malaria drug could offer hope for addressing the burden of malaria in babies, which despite being a leading cause of death across Africa, is often underdiagnosed, mistreated, and not studied in this population. There are no malaria treatments for babies weighing under 11 pounds (about three months old or younger), whose cases also often go undiagnosed because malaria presents differently and can easily be mistaken for common childhood illnesses in children this young or they have not even been tested due to resource shortages. Clinical trials, including those for the RTS,S and R21 malaria vaccines, often exclude children under five months because of the assumption that mothers confer immunity. The ongoing trial, which is supported by the PAMAfrica Consortium and co-funded by the European & Developing Countries Clinical Trials Partnership and Medicines for Malaria Venture, is expected to publish results early next year.The Novo Nordisk Foundation has announced a new initiative, developed with the University of Copenhagen, that will invest up to $260 million to create new or improved vaccines for serious respiratory diseases. It is the first global vaccines initiative to solely focus on how to produce immunity in the airway itself as a way to prevent airborne disease infection. The initiative will initially focus on candidates for tuberculosis, the flu, and Group A Streptococcus. The partners hope that the new project can help to address the rise of antimicrobial resistance, which is driven, in part, by the overuse or misuse of antibiotics to treat airway infections, as well as to address the high death toll globally from these diseases.The European Medicines Agency Committee for Medicinal Products for Human Use recently adopted a positive scientific opinion for the investigational drug arpraziquantel for schistosomiasis, a neglected tropical disease that affects more than 240 million people globally, including 50 million preschool-aged children. There is no child-friendly schistosomiasis medication for preschool-aged children, despite safe and effective treatments available for both adults and school-aged children. The Global Health Innovative Technology (GHIT) Fund has supported the Pediatric Praziquantel Consortium’s development of the drug since 2013 and is now working with the consortium’s implementation research program to prepare for the introduction of the drug in endemic African countries to ensure equitable and sustainable access in the countries where it is most needed.

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.