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WASHINGTON, DC—The ticking time bomb of extensively drug-resistant tuberculosis (XDR-TB), an infection that is easy to transmit and almost impossible to cure, has been defused. Today, a new drug, pretomanid, has been approved by the US Food and Drug Administration (FDA) for use in a treatment for XDR-TB. Amazingly, it’s the first time that a treatment for XDR-TB infections has been recognized for actually working—no other treatment has demonstrated any consistent effectiveness. Up until now, people with XDR-TB had to suffer through up to two years or more of toxic treatment that worked only one third of the time. Today’s news means that treatment time is drastically reduced—to six months—while the effectiveness of treatment is significantly improved. We welcome this approval as it shows the real-world impact of US government investment in finding new cures and vaccines for the world’s deadliest diseases. The developer of pretomanid, the nonprofit organization TB Alliance, could not have succeeded in advancing this breakthrough without support from the American people, through the US Agency for International Development (USAID) and National Institutes of Health (NIH). As federal spending for the coming fiscal year continues to be debated in Congress, we hope that this breakthrough bolsters our commitment to fighting global diseases with investments in scientific research.CONTACT: Katy Lenard, klenard@burness.com, +1 301-280-5719

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. Researchers at Purdue University have created a device that can rapidly detect the bacterium which causes cholera in water. Unlike traditional tests, which require a well-equipped laboratory and three to five days to process results, this device acts as a portable “cholera detection lab” built around a smartphone. A water sample is placed in a single-use, disposable test kit which uses chemicals that make copies of the toxin gene in cholera bacteria in a process called amplification. If the water becomes more viscous, it signals that harmful bacteria has been identified and the imaging system on the smartphone will capture the results, which can be sent to researchers or charities who can address the water quality issue. The device is currently in early field testing. The nonprofit Sabin Vaccine Institute (Sabin) has acquired the rights from GSK to develop three experimental, single-dose vaccines for Marburg virus, Ebola Sudan, and Ebola Zaire—the strain of the Ebola virus responsible for the yearlong outbreak in the Democratic Republic of the Congo (DRC). Sabin will develop these vaccines in collaboration with the National Institutes of Health Vaccine Research Center, whose scientists originally designed the vaccines which all use the same approach to induce immunity. Though the vaccines have not been tested in phase 3 trials, which would show their efficacy in preventing infection, a phase 2 trial conducted at the end of the West African Ebola outbreak showed that the Ebola Zaire vaccine produced an antibody response in most recipients that lasted up to a year. The largest-ever trial of a preventive Ebola vaccine in Uganda began last week, amid fears of the virus spreading from neighboring DRC. The two-year trial, which will test a two-dose Ebola candidate vaccine developed by Janssen Pharmaceuticals of Johnson & Johnson, will involve 800 participants picked from core health workers and non-core personnel in the Mbarara district, located in the southwest of the country, and will assess the vaccine’s safety and efficacy in inducing an immune response to prevent the disease. The trial will be conducted by both Ugandan and international researchers and is sponsored by the London School of Hygiene and Tropical Medicine. Ebola has killed more than 1,800 people in the DRC during this latest outbreak, which began over a year ago.

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. The National Institutes of Health (NIH) is hoping that an ambitious effort to create a “Google” for biomedical research could help researchers connect the dots between health data sets to unlock new scientific insights and discoveries. Launched by NIH in 2016, the Biomedical Data Translator program is attempting to create a tool that would integrate different data sources, ranging from electronic health records to clinical trial results, and apply machine learning techniques to reason through the information allowing researchers to make connections between not previously associated datasets and identify trends across them. So far, the program has awarded approximately US$17.5 million to 19 institutions across the country working to integrate and organize years of data. The initial feasibility phase of the project is set to end this year. Surveys conducted by the World Health Organization (WHO) in 18 countries from 2014 to 2018 reveal an alarming surge in resistance to critical HIV drugs. In the past four years, 12 countries in Africa, Asia, and the Americas have surpassed the acceptable levels of drug resistance against two key HIV drugs, efavirenz and nevirapine—showing more than ten percent of adults with HIV have developed resistance to these drugs in these nations. Though the causes of drug resistance are unclear, the co-author of a WHO report on the survey’s findings suggests drug-resistant HIV may develop when people interrupt treatment. In response to this evidence, WHO recommends that countries use dolutegravir as first-line treatment against HIV since the likelihood the virus will develop resistance is lower with dolutegravir than with other antiretrovirals. The Coalition for Epidemic Preparedness Innovations (CEPI) will provide biotech company, Valneva, with up to $23.4 million to fund the development of a single-dose, live-attenuated vaccine for Chikungunya—a mosquito-borne disease which causes fever, severe joint pain, muscle pain, and fatigue. The funding from CEPI will support vaccine manufacturing and late stage clinical development to help accelerate regulatory approval of the vaccine for use in regions where outbreaks occur. Valneva plans to maintain a stockpile of the vaccine and transfer its manufacturing to Chikungunya-endemic regions. Since Chikungunya re-emerged in 2004, approximately 3.4 million cases in 43 countries have been identified.