Breakthroughs Blog: Research Roundup

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, doctors in China reported that the malaria drug hydroxychloroquine helped to speed the recovery of a small number of patients who were mildly ill from COVID-19, the disease caused by the novel coronavirus. Symptoms such as cough, fever, and pneumonia went away faster, and the disease was less likely to become severe in people who received hydroxychloroquine than in a comparison control group that did not receive the drug. The study was small with just 62 individuals, limited to patients who were only mildly or moderately ill, and excluded patients with underlying conditions that could be made worse by hydroxychloroquine. The authors of the report noted hydroxychloroquine is a promising treatment for COVID-19 but that more research is required, including on how it works in treating the disease and how best to use it.The US government has made deals with Johnson & Johnson (J&J) and Moderna Inc—and is reportedly in talks with two other companies—to prepare them to mass produce coronavirus vaccines before one that is safe and effective has even become available. Last Monday, J&J announced a US$1 billion deal to create enough manufacturing capacity to produce more than one billion doses of a vaccine candidate that will not begin testing until September. This effort will be funded in part by the Biomedical Advanced Research and Development Authority (BARDA). Moderna, which has already begun human clinical trials of a vaccine candidate supported by the National Institutes of Health, also signed a deal with BARDA—an agency which ultimately plans to support five or six experimental vaccine candidates with the hopes of having two or three successful ones. There are currently no approved vaccines for COVID-19, and experts have estimated it could be 12 to 18 months before one receives regulatory approval.The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a new coronavirus test that takes only 15 minutes. The test from Abbott runs on its point-of-care ID NOW platform and weighs less than seven pounds, so it can be easily deployed to disease hotspots. This test is one of the fastest tests for COVID-19 available and comes just weeks after FDA EUA approval of a 45-minute rapid point-of-care test. Abbott plans to deliver 50,000 tests per day starting last week and plans to produce about five million tests per month. Public health experts say that a key factor in ending the spread of coronavirus is to dramatically increase testing. A lack of availability of COVID-19 test kits has been a point of contention in the United States, which now has the largest number of COVID-19 cases of any country in the world.

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. Due to overwhelming demand, Gilead Sciences has paused granting patients access to remdesivir, an experimental drug which up until now has been used under a “compassionate use” policy against COVID-19—the disease caused by the novel coronavirus. In a statement, the company said it is focused on processing previously approved requests and establishing a new system that allows patients to get the drug in a similar time frame to what it would have taken to work through the requests it has already received. The company will make exceptions for pregnant women and children under the age of 18, as well as those with confirmed cases of COVID-19 who are experiencing “severe manifestations” of the disease. Gilead noted that, in recent weeks, there has been an “exponential increase” in requests for compassionate use of remdesivir due to the spread of COVID-19 in the United States and Europe, which has flooded the treatment access system which was never intended for use in response to a pandemic. Remdesivir is currently being studied in five large clinical trials, two of which could yield results in early April. The World Health Organization (WHO) has announced it will launch a multi-arm, multi-country clinical trial, known as the SOLIDARITY trial, for potential coronavirus therapies. The trial will test four drugs or drug combinations already licensed and used for other illnesses as part of a global effort to identify treatments for COVID-19. The four therapies include the antiviral drug remdesivir; a combination of two HIV drugs, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta; and the antimalarial drug chloroquine—all of which have shown some effectiveness against the novel coronavirus either in vitro and/or animal studies. These therapies will be compared to the standard of care—the regular support hospitals treating patients currently use, such as supplementary oxygen. Ten countries have already indicated they will take part in the trial. WHO launched a similar trial in the Democratic Republic of Congo in November 2018 to test four therapies against Ebola. Phase 2 and 3 clinical trials of Takeda’s tetravalent dengue vaccine candidate showed that it is safe, produces immunity in children, and protects against the disease—regardless of previous exposure to different strains of the virus—according to studies published in The Lancet. In the phase 3 trial, researchers found an overall vaccine effectiveness of 80.2 percent in the first 11 months and 73.3 percent in the first 17 months. Takeda’s dengue vaccine candidate is only the second dengue vaccine to enter clinical trials, following Sanofi Pasteur's Dengvaxia. Sanofi’s vaccine was 56–61 percent effective in preventing dengue in children, but it was tied to severe illness in some individuals vaccinated without having prior exposure to infection. Dengvaxia was approved by the US Food and Drug Administration last May, but with caveats due to potential adverse effects. Takeda is conducting clinical trials in dengue endemic countries before seeking regulatory approval.

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.