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. A new analysis has found that many of the products needed to combat the world’s most prevalent infectious diseases are not likely to be developed based on the current candidates in the research and development (R&D) pipeline and exposed significant funding gaps for R&D. According to the analysis—which was conducted by Duke Global Health Institute using a modelling tool developed by the World Health Organization’s Special Programme for Research and Training in Tropical Diseases (TDR)—there are 500 products for neglected diseases already in development which would cost an estimated US$16.3 billion to complete, yielding approximately 128 expected product launches. Additionally, the study identified 18 high-priority products it deemed “missing” from the current pipeline, such as vaccines for HIV and AIDS, tuberculosis, and hepatitis C. The research also exposed an annual funding gap of $1.5–2.8 billion, comparing current annual spending on product development to the costs required to move current products through the pipeline as well as develop the 18 “missing” products. TB Alliance announced the launch of a new clinical trial, known as SimpliciTB, which will evaluate whether a new four-drug regimen against tuberculosis (TB) can treat most types of the disease more quickly and effectively than currently available treatments. The trial, which will launch in Tbilisi, Georgia, will enroll 450 patients across at least 10 countries. It will test the efficacy of a four-month treatment with the BPaMZ regimen—comprised of the newly FDA-approved drug bedaquiline, an investigational drug known as pretomanid, a re-purposed antibacterial medication called moxifloxacin, and a standard drug regularly used in treatment, pyrazinamide—in individuals with drug-sensitive TB. It will also test a six-month regimen of BPaMZ among patients with multidrug-resistant TB. A previous eight-week trial of the BPaMZ regimen among 250 patients revealed that patients on the regimen cleared bacteria at the fastest rate ever seen, up to three times faster than the standard first-line regimen. If proven successful in SimpliciTB, the BPaMZ regimen could significantly impact the way TB is treated globally. Competition between parasite strains in a human host reduces the odds of drug resistance developing in a high-transmission area, according to a new mathematical model for malaria developed by researchers at Emory University and the Centers for Disease Control and Prevention's Division of Parasitic Diseases and Malaria. Where multiple strains of malaria already exist, a drug-resistant strain will usually go extinct simply because it has the disadvantage of being a “late-comer.” However, if a drug-resistant strain does become established, that same competition facilitates the spread of the drug-resistant strain more quickly. The researchers are developing a software tool based on the model they’ve developed, which can be applied to studying a range of pathogens and infectious 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 large-scale study has shown that monthly injections of two long-acting HIV drugs are just as effective as taking daily pills. The phase III study, led by ViiV Healthcare—a London-based collaboration between GlaxoSmithKline and Pfizer—tested an experimental drug, cabotegravir, and rilpivirine in 618 HIV-infected people from 13 different countries over a 48 week period. It found HIV viral suppression levels were the same in both individuals taking daily pills and individuals receiving a monthly injection of each drug. Long-acting HIV medications have the potential to transform the way HIV is both treated and prevented, offering an alternative option for people who find it challenging to adhere to taking daily pills. It is possible ViiV could apply for regulatory approval for these drugs as early as next year. The world could be one step closer to a universal flu vaccine, according to a study out of the University of Pennsylvania Perelman School of Medicine. Researchers there have developed a flu vaccine candidate that was found to elicit a strong antibody response to a structure on the surface of flu viruses, called the hemagglutinin (HA) stalk and protect mice from infection of various flu strains. The HA stalk has been a target for universal flu vaccines as it does not vary from one flu subtype to another, unlike seasonal flu vaccines that target the “head” region of the HA protein which tends to mutate rapidly and varies by flu type. The experiment was repeated successfully in ferrets and rabbits. The scientists’ next step is to test the vaccine in non-human primates and then humans. A group of students at Makerere University in Kampala, Uganda have invented a low-cost, reusable device to detect malaria quickly without drawing blood. Deemed a “game changer” by the Royal Academy of Engineering, which recently honored the product’s research team with its Africa Prize for Engineering Innovation, the simple device, called Matibabu, uses magnets and a matiscope to detect the deadly disease. A matiscope is a custom-made device that shines a red beam of light on to a user’s finger to detect whether a substance known as haemozoin crystals, a by-product of the malaria parasite, is present. The latest prototype of the device only requires two minutes to detect malaria, as opposed to 30 minutes or more when using a microscope. Since no blood is drawn, the device has the potential to be administered by non-specialists at the community level. The inventors of the device still have a few hurdles to overcome. For example, the current model only detects 80 percent of malaria cases, which misses the mark of the international norm of 99 percent. With supplemental funding, the developers hope to further refine the device and bring it to market within two years.

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. Clinical trials have begun for the latest vaccine candidate against the Zika virus. The trial, which will include 28 adult participants, will test the safety and immune response from the vaccine, which contains a weakened form of the virus created from the combined genetic material of different viral strains. If the vaccine candidate is found to be safe, it could be added to another vaccine candidate currently undergoing testing for effectiveness against four types of dengue—creating a single vaccine against both diseases. Both vaccine candidates were developed at the National Institute of Health’s National Institute of Allergy and Infectious Diseases. On August 10, the US Food and Drug Administration approved Annovera, the first-of-its-kind self-insertable contraceptive vaginal ring that can be used for an entire year. Annovera, developed by the Population Council, is being heralded as a revolutionary new option for low-income women as it can be used for a year without a return trip to the physician or pharmacy and does not require refrigeration. Along with the benefits it offers regarding convenience, Annovera also offers women versatility. “Annovera offers the convenience of a long-acting method like the IUD because there is no daily action needed, but the control of a short-acting method like the pill because a woman can start or stop it at any time,” said Julia Bunting, president of the Population Council. Although pricing for Annovera has not yet been made public, the Population Council is continuing its efforts to make the product available to the approximately 214 million women in low- and middle-income countries that have an unmet need for contraception. Annovera is expected to hit the market at the end of 2019 or early 2020. A new type of bednet—that combines a chemical that kills mosquitoes with another that impedes their reproduction—was found to reduce clinical malaria cases by 12 percent, compared to conventional nets, during a two-year clinical trial in Burkina Faso. The study also showed a 51 percent reduction in risk of a malaria-infective mosquito bite in areas with the combination bednets. The bednets used in the study combine a pyrethroid insecticide, which repels and kills mosquitoes, with pyriproxyfen, an insect growth regulator that shortens the lives of mosquitoes and reduces their ability to reproduce. With mosquitoes increasingly becoming resistant to the pyrethroids used in conventional nets, these bednets offer an alternative to fighting malaria in areas where mosquitoes have become resistant.

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 Ministry of Public Health of the Democratic Republic of Congo has launched Ebola vaccinations for high-risk populations only one week after announcing the latest outbreak of the disease in the North Kivu province. Of the 44 cases reported so far, 17 have been confirmed. A total of 3,220 doses of the rVSV-ZEBOV vaccine candidate, developed by Merck, are currently available in country while additional doses have been requested. An agreement between Gavi, the Vaccine Alliance and Merck will ensure additional doses of the vaccine are available on an emergency basis as it goes through the licensing process. The World Health Organization has provided key logistical support in establishing a cold chain and sending necessary supplies for the vaccinations, aiding in the deployment of vaccine experts, and facilitating the negotiation of protocols with the manufacturer and the national authorities. Biobanks provide vital specimens and infrastructure to support scientific research and innovation. While in the developing world, biobanks are well established, issues such as unreliable internet connectivity, a lack of access to resources such as water and electricity, a lack of highly skilled and trained personnel, and the cost of setup have stifled their establishment in low- and middle-income countries (LMICs) on the African continent. Despite these barriers, LMICs in Africa should prioritize setting up biobanks, argues a group of researchers from the University of Western Cape and Stellenbosch University. They write, “Having access to rich genetic diversity across Africa would allow researchers to understand disease, develop better diagnostics and treatments, medicines and vaccines, geared toward the continent’s population.” A single-dose Zika vaccine candidate developed by researchers at The Ohio State University has proven effective in triggering an immune response in mice, according to a recent study. The vaccine uses a weakened, harmless form of the Vesicular stomatis virus—also known as foot-and-mouth diseases in cattle—to deliver proteins from the Zika virus. This method has been used with other vaccines, such as the Ebola vaccine being used in the recent outbreaks. While further testing is required to see if it is effective in humans, the vaccine candidate’s suggested ability to elicit an immune response with one dose means it has the potential to be especially valuable in hard-to-reach areas and low-resource settings.

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. In this editorial piece, Dr. Jenniffer Mabuka of the African Academy of Sciences makes a case that Africa needs to develop a research base to help detect and monitor a range of pathogens and better address disease outbreaks on the continent. Mabuka explains, “A thorough base of research would result in tools that will speed up detection and containment of future outbreaks, generate the knowledge base to help predict future outbreaks of known origins, and help accelerate the development of diagnostics, efficacious drugs and vaccines.” She notes that investing in research and development must be a priority for African governments as recent outbreaks serve as a reminder that equatorial Africa is a hotbed for emerging and re-emerging diseases. A group of scientists has developed a technique to modify a strain of rice to produce HIV-neutralizing proteins. While further study is needed, the researchers believe this technique could offer promise as a low-cost approach for low- and middle-income countries to manufacture topical microbicides, which are compounds that can be applied to the vagina or rectum to reduce the risk of HIV infection. Given the research team was able to alter the rice to simultaneously produce three key proteins, a combination necessary to produce a microbicide with broad coverage against multiple HIV strains, the plant’s seed extract could be used directly as a microbicide without the need for additional costly processing. Researchers at Vanderbilt University Medical Center have achieved an important step forward in developing a broadly effective antibody treatment against the three major Ebola strains. The research team reported the isolation of two potent monoclonal antibodies from human survivors of the Ebola virus. In cell culture studies, these antibodies efficiently neutralized the Zaire, Sudan, and Bundibugyo strains of the virus. Further study is required to determine if these antibodies can be combined into an injectable for use in people at high risk of being infected with the Ebola virus. The hope is that the injected antibody “cocktail” would seek out and destroy the virus before it has the chance to wreak havoc on the human body.

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. In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The latest Ebola outbreak in the Democratic Republic of Congo was officially declared over last Tuesday, following a 42-day observation period since the last new case was reported. Health experts credit the use of an experimental vaccine and a speedy and effective response by both the government and the World Health Organization as key factors in controlling this outbreak. Two clinical studies revealed that GlaxoSmithKline’s two-drug treatment for HIV, a combination of dolutegravir and lamivudine, also known as 3TC, is as effective as the standard triple therapy. Crucially, the studies showed that the efficacy of the treatment was consistent whether individuals had higher or lower levels of HIV in their blood, dispelling notions that the two-drug regimen might not work as well in people with more virus. Questions remain regarding the durability of treatment and potential drug resistance, given that the data only spans a 48-week period. The two-drug combination is slated for regulatory submission later this year. The US Food and Drug Administration approved the first new treatment for Plasmodium vivax malaria in 60 years. The drug, tafenoquine, is a single-dose treatment developed by GlaxoSmithKline and Medicines for Malaria Venture. P. vivax malaria causes around 8.5 million infections every year in Asia, Latin America, and parts of Africa. The disease is tricky to combat because the P. vivax parasite can lie dormant in the liver, where it reactivates, and can cause new episodes of malaria weeks, months, and years after the initial infection. In a study of 522 patients, 60 percent saw no relapse six months after taking the drug. Tafenoquine has been submitted for approval to the Australian regulatory authority and is slated to be submitted for approval in malaria endemic countries.