Ansley Kahn

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. According to a report released last week by the Access to Medicines Foundation, just five companies are carrying out 63 percent of the urgently needed research and development projects for priority health areas such as HIV and AIDS, tuberculosis, Chagas disease, and leishmaniasis. This reliance on a small group of companies contributes to a fragile ecosystem, according to the report authors. A change in strategy for any of the companies could put access to medicines in low- and middle-income countries (LMICs) at risk. The Access to Medicines index, an independent report released every two years, ranks the world’s 20 largest pharmaceutical companies based on their efforts to make their medicines available in LMICs. This year, GlaxoSmithKline—the developer of a single-dose drug to prevent malaria relapse—tops the list of companies in the overall ranking.  Recruitment of women in Uganda has begun for a phase 3 clinical trial, which will assess if a long-acting injectable antiretroviral called Cabotegravir, administered every two months, is safe and effective as a form of Pre-Exposure Prophylaxis (PrEP) to reduce an individual’s risk of contracting HIV when exposed to the virus. This recruitment is part of a large-scale, five-year trial that will be conducted in six additional countries—including Kenya, Malawi, Botswana, Zimbabwe, South Africa, and Swaziland—among approximately 3,200 HIV-negative individuals who are at a high risk of contracting the virus. If Cabotegravir proves to be safe and efficacious, it would offer a new alternative for individuals on PrEP other than taking daily oral pills. A vaccine to prevent Zika virus infection was found to be safe and induce an immune response in an early stage trial, according to an announcement released on November 19 from developer Emergent BioSolutions Inc. and partner Valneva SE. The vaccine, VLA1601, was tested in two doses in 67 adult trial participants. The initial results contained analyses up to day 56, after the first vaccination. Final analysis will take place up to day 208 and is expected to be released in the first quarter of 2019. Emergent BioSolutions Inc. announced an exclusive worldwide licensing deal for Valneva SE’s Zika vaccine in July of last year.

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 first all-oral drug for sleeping sickness received a positive scientific opinion Friday from the European Medicines Agency, paving the way for the treatment to be rolled out in endemic countries in 2019. Developed by the Drugs for Neglected Diseases initiative (DNDi) and Sanofi, fexinidazole is a tablet taken once daily for ten days that treats the most common form of sleeping sickness, a neglected tropical disease spread by tsetse flies that causes neuropsychiatric symptoms and can be deadly if left untreated. Current treatments for sleeping sickness require a complicated series of infusions and pills, are costly, and involve long hospital stays, which pose a huge burden on health systems to treat the disease. Fexinidazole is a simple once-a-day pill that could reduce this logistical burden. About 65 million people in sub-Saharan Africa are at risk of sleeping sickness. A novel device colloquially known as a “wiggle- ometer” may one day help physicians and health workers fight the growth of antimicrobial resistance (AMR). The device, which is a sub-cellular fluctuation imaging machine, detects minute movements in bacteria to determine whether they’ve been affected by an antibiotic, signaling to doctors whether a specific antibiotic works against a specific infection. Today, many physicians prescribe a broad-spectrum antibiotic to patients because of the lack of access to rapid diagnostic tests to determine the nature of an infection and what antibiotics will be effective against it. This overuse and misuse of antibiotics drives the growth of AMR. The “wiggle-ometer” is one of more than 70 projects from around the world competing for the £8 million Longitude Prize, launched by the United Kingdom government to fight AMR. The prize will be awarded to a team that develops an affordable, accurate, easy-to-use test for bacterial infections. Merck has begun the process of submitting the evidence required for regulatory approval of its experimental Ebola vaccine with the US Food and Drug Administration (FDA). The FDA gave the vaccine a “breakthrough therapy designation” in 2016—a form of regulatory fast track which allows a manufacturer to meet more frequently with the FDA to discuss filing and to submit material on a rolling basis, all with the aim of speeding the item through licensure. Merck’s experimental Ebola vaccine is currently being used in the Ebola outbreak in the Democratic Republic of Congo under compassionate use protocol, after having shown to be protective in a clinical trial in Guinea at the end of the West African Ebola outbreak of 2014-2016. Though there are a few experimental Ebola vaccines in development, Merck’s is furthest along in development. Merck initially planned to file with the FDA in 2017 but missed that goal due to “unexpected engineering and construction delays” at the manufacturing plant built to produce the vaccine. Merck now says it hopes to complete the filing process sometime next year.

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. After hitting its primary goal in a phase 2 trial, Themis may be one step closer to developing a vaccine to protect against chikungunya—a disease which causes debilitating joint pain and for which there is currently no treatments or vaccines. MV-CHIK, Themis’ chikungunya vaccine candidate, was tested at two dose levels in a total of 263 participants and was found to induce neutralizing antibodies against the disease in all groups after two injections. Themis reported seroconversion rates ranging from 86 to 100 percent, touting the vaccine candidate as “promising and potentially effective” against the disease. Themis is looking to move the vaccine candidate into a phase 3 study “in the near term” and will likely pursue a priority review voucher, as the US Food and Drug Administration recently added chikungunya to its list of eligible diseases.  A new study suggests that frontline health workers in the Democratic Republic of Congo who received experimental Ebola vaccines could be protected against the virus for longer than a year. The study, which tracked healthy volunteers in the United Kingdom who received vaccines against Ebola between 2014-2016—including Merck’s rVSV-ZEBOV, GlaxoSmithKline’s ChAd3 EBOV, and Janssen’s AdHu26—found that after two-and-a-half years, those vaccinated still have a strong antibody response to the virus. These findings provide insight into how the vaccines can be used in future outbreaks in the region and how health care workers could be vaccinated before the disease becomes widespread during an outbreak. Researchers now plan to give a booster dose to the study participants to determine how it adds to their immunity. By utilizing the same technology used to develop the Ebola vaccine—a technology known as viral vectors—researchers also believe they can speed the development of vaccines for other infectious diseases. Researchers at the University of Southern California believe they have identified a panel of biomarkers specifically associated with symptomatic Zika infection during pregnancy—a discovery which could lead to the development of new prenatal screening tests to detect fetal abnormalities caused by the virus, as well as a better understanding of how Zika causes these abnormalities. During the study, researchers examined the immune systems of pregnant women through blood samples—comparing the samples of 30 Zika-infected pregnant women in Brazil to 30 healthy pregnant women in Brazil and 14 in Los Angeles. The researchers specifically examined cytokines, messenger chemicals released by the body in response to an infection, and identified 16 cytokines associated with abnormal births from Zika. However, it is unclear if the cytokines cause the birth abnormalities or are released in response to another cause.

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. Experimental treatments for Ebola administered during the most recent outbreak in the Democratic Republic of Congo (DRC) appear to be working, according to preliminary data presented at the annual meeting of the American Society of Tropical Medicine and Hygiene. Four treatments are in use, including remdesivir, an antiviral drug; mAb114, a human antibody cloned from a survivor of an outbreak years ago in Zaire; REGN-EB3, a cocktail of cloned human antibodies; and ZMapp, a cocktail of antibodies made from a blend of human and mouse proteins. The death rate among patients in the DRC who received one or more of the experimental treatments was 43 percent—32 percent if the count excluded patients who were within hours of death when they arrived at the hospital. Experimental treatments for Ebola administered during the most recent outbreak in the Democratic Republic of Congo (DRC) appear to be working, according to preliminary data presented at the annual meeting of the American Society of Tropical Medicine and Hygiene. Four treatments are in use, including remdesivir, an antiviral drug; mAb114, a human antibody cloned from a survivor of an outbreak years ago in Zaire; REGN-EB3, a cocktail of cloned human antibodies; and ZMapp, a cocktail of antibodies made from a blend of human and mouse proteins. The death rate among patients in the DRC who received one or more of the experimental treatments was 43 percent—32 percent if the count excluded patients who were within hours of death when they arrived at the hospital. This compares to a death rate of 68 percent for Ebola patients in hospitals before the new treatments were approved for emergency use. A once-monthly injection proved as effective in suppressing HIV as daily pills in a second study by GlaxoSmithKline—potentially paving the way for a new treatment regimen that could be simpler for some people living with and seeking to suppress HIV. In the study, HIV-positive adults—who had not been on a long-established, daily three-drug oral regimen—were put on a 20-week, three-drug program of daily pills to suppress the virus before being switched to a monthly two-drug injection of cabotegravir and rilpivirine. After 48 weeks, the injection maintained a similar rate of suppression as the pills, supporting the results of an earlier study which involved adults who were on a daily, three-drug oral regimen to control the virus. The trial provides further evidence that a long-acting injection could offer an alternative to a daily, oral treatment regimen for people who previously achieved viral suppression. Dogs could offer a noninvasive way to detect malaria, according to a recent study presented at the annual meeting of the American Society of Tropical Medicine and Hygiene. In the study, a trio of dogs correctly “sniffed out” socks worn by malaria-infected children 70 percent of the time and those worn by non-infected children 90 percent of the time. The study focused on asymptomatic malaria carriers because of their key role in malaria’s persistence, since they act as hidden reservoirs of the disease. In the study, nylon socks were given to nearly 600 Gambian children to wear overnight and then frozen for 15 months while the dogs were trained to sniff out the disease, as previous research has shown that malaria alters the compounds that make up a person’s odor. While it may not be economically feasible to train and deploy dogs to all malaria-endemic countries, malaria-detection dogs could work at ports of entry in countries that have eliminated the disease and want to keep it out. This research also provides further evidence of the capabilities of dogs and their ability to help detect deadly diseases.

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 12-month pilot research study conducted in rural Zambia found that administering a suppository form of a malaria-fighting drug to children without immediate access to a health facility drastically cut the number of child deaths caused by the disease. During the pilot, child deaths related to severe malaria were cut from eight percent to 0.25 percent. There were only three child deaths during the study period—94 fewer than would be expected in the same time frame, according to Medicines for Malaria Venture, one of the study’s research partners. During the pilot, all children suspected of having severe malaria were given the suppositories as a pre-referral treatment. This form of drug offers advantages as it can be administered even if a child is unconscious or vomiting. Children who received the suppository were then transferred to a health facility where they were given injectable artesunate malaria medication, followed by a three-day oral antimalarial treatment course. Researchers hope this model can be replicated in other rural settings where there is a high prevalence of malaria and limited access to health workers. Johnson & Johnson (J&J) unveiled promising early-stage results for a tetravalent mosaic-based HIV preventative vaccine regimen. This announcement follows a large-scale efficacy study J&J launched last November to test the tetravalent vaccine regimen in five sub-Saharan African countries. In this early-stage study, known as TRAVERSE, a vaccine regimen including the tetravalent vaccine candidate—which targets four strains of the HIV virus—was found to broaden immune responses to different HIV-1 strains when compared to the trivalent, or three-strain, version. J&J is conducting the TRAVERSE study in 200 patients in the United States and Rwanda. Study participants will receive two prime doses of either vaccine, followed by two boosters at weeks 24 and 48. These initial results are from after week 28, or after the first boost. J&J said findings from the TRAVERSE study were critical to the company’s decision to start the large-scale efficacy testing. In a clinical trial conducted in Belarus, a new treatment for a drug-resistant strain of tuberculosis (TB)—bedaquiline—administered alongside other antibiotics, was found to cure 80 percent of individuals. Of the 181 trial participants given the drug regimen, 168 completed the course and 144 were cured. The Belarus cure rate was largely replicated in bedaquiline trials in other nations in eastern Europe, Africa, and Southeast Asia. According to the World Health Organization, cases of multidrug-resistant TB have been reported in at least 117 countries around the world with only 55 percent of people treated successfully.

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. Major funders are betting that a new online platform for genetic sequencing will help health workers worldwide more easily identify mysterious infections and track disease outbreaks. The platform, IDseq, seeks to make metagenomics sequencing—the analysis of genetic material and the matching of those readouts to databases of known microbes—, which can be expensive and technically demanding, more accessible and affordable, particularly in low-resource settings. Free and based in the cloud, IDseq allows researchers to upload patient data, which is then “crunched” against existing databases, to determine what infection a patient has. The Chan Zuckerberg Initiative is supporting the platform’s development, and the Bill & Melinda Gates Foundation announced last week a new training program to support clinicians around the world in using the platform. In an early stage trial, a combination of two broadly neutralizing antibodies (bNAbs)—proteins that can bind to different strains of HIV and prevent the virus from entering human cells—suppressed blood levels of HIV for months after treatment in some people. Participants received up to three infusions of bNAbs over a six-week period with their viral load monitored every one to two weeks. Though further testing and refinement is required, long-acting bNAbs combinations may eventually become an alternative to daily anti-HIV drugs. Researchers hope to test whether engineering the antibodies to last longer in the blood can improve viral suppression and explore new combinations with additional antibodies or other drugs. The Global Antibiotic Research & Development Partnership (GARDP) and Novartis are joining forces to reduce child deaths from antimicrobial resistance (AMR) by accelerating the development of generic antibiotic treatments for children. The strategic partnership will focus on: 1) enhancing the availability of generic antibiotics and increasing access for children in low- and middle-income countries, 2) developing heat-stable pediatric formulations, and 3) leveraging the knowledge and shared expertise of both partners. The partnership between GARDP and Novartis is a response to the World Health Organization’s call for affordable, improved, and adapted antibiotics for this vulnerable population, for which treatment options are limited.