Breakthroughs Blog: Medicines

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. Merck plans to seek authorization for its COVID-19 antiviral pill after clinical trial results showed the drug, molnupiravir, cut the risk of hospitalization or death in half among high-risk individuals early in their infections. An independent board of experts monitoring the study data had recommended that the trial be stopped early because the drug’s benefit to patients had proved so convincing, and the US Food and Drug Administration agreed, according to Merck. The drug, designed to stop the virus from replicating, is taken as four capsules twice a day for five days. As an oral antiviral treatment, the pill could be a crucial new tool in combating COVID-19 by reaching more people than the antibody treatments being widely used in the United States.COVID Moonshot, an open-source effort to design a COVID-19 pill, has won US$11 million, or GBP£8 million, from the Wellcome Trust to develop a low-cost, broadly available antiviral to fight the pandemic. The project, coordinated by the Drugs for Neglected Diseases initiative, is a nonprofit consortium of scientists that began in March 2020 and led to around 250 people submitting more than 4,500 potential molecular designs intended to block the key protein that helps the virus replicate. The new funding, through Wellcome on behalf of the COVID-19 Therapeutics Accelerator, will help pay for the expensive last step of research needed to bring the project into human clinical trials. Moonshot hopes to have a compound able to be tested in humans by next year.Sanofi’s mRNA-based COVID-19 vaccine showed positive results in a phase 1/2 clinical trial, the company announced last week, providing confidence in its mRNA program that will now be used to pursue vaccines against other pathogens, including influenza. Sanofi will not be continuing to develop its mRNA COVID-19 vaccine, as the market will have been saturated by the time it would be authorized, the company said. In the preliminary phase 1/2 trial results, 91 percent of people who received the lowest tested dose saw their neutralizing antibody levels increase four-fold, a measure thought to equate to a protective level of antibodies, confirming that the mRNA platform is potent, can generate a strong immune response, and has no safety signal. Sanofi will now turn to accelerating its work on a vaccines “center of excellence” intended to be ready to produce vaccines when the next pandemic hits.

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. New study results show that combining antimalarial drugs with a vaccine, given just before peak transmission period of rainy season, could reduce malaria deaths in children by more than 70 percent. The trial—conducted over three years among 6,000 young children in Burkina Faso and Mali—tested the RTS,S malaria vaccine, the world’s first-developed shot for the disease, along with seasonal malaria chemoprevention (SMC), an existing preventative drug regimen. Results indicated the RTS,S vaccine was as effective as SMC when administered to children ahead of rainy season in countries with seasonal transmission—and that combining the two methods reduced cases by around 60 percent, hospitalizations by around 70 percent, and deaths by around 73 percent, when compared to SMC alone. The World Health Organization (WHO) is set to review evidence from the study in October.The International Vaccine Institute (IVI) and Bharat Biotech have launched a phase 2/3 trial for their chikungunya vaccine candidate. The two-dose vaccine, BBV87, is an inactivated whole virion vaccine, which showed “optimum immune response” in phase 1 studies in India. The phase 2/3 trial, led by IVI through the Global Chikungunya vaccine Clinical Development Program (GCCDP) in partnership with Bharat Biotech and supported by the Coalition for Epidemic Preparedness Innovations and the government of India’s epidemic preparedness initiative, Ind-CEPI, will test BBV87 for safety and immunogenicity in healthy adults. GCCDP aims to develop and manufacture an affordable chikungunya vaccine with the goal of achieving WHO prequalification to enable distribution in low- and middle-income countries. The trial has begun in Costa Rica and is set to expand to Panama, Colombia, Thailand, and Guatemala in the coming months.On Tuesday, the US Food and Drug Administration granted its first emergency use authorization for an at-home COVID-19 diagnostic that delivers results through the user’s smartphone. The Veritor rapid antigen test, developed by BD and Scanwell Health, involves swishing a nasal swab in a tube of liquid reagents, after which drops on a testing strip trigger colored lines, which are then read and interpreted by the smartphone. The diagnostic is designed for use by individuals ages 14 and up and can be used for children as young as two with samples collected by an adult. The digital test, which does not require a prescription, will initially be made available to employers, schools, and public health organizations looking to support routine screening programs.

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. Moderna is launching human trials for two new HIV vaccines based on the mRNA technology used in its COVID-19 vaccine, the company announced last week. The phase 1 trial will recruit 56 participants between the ages of 18 and 50 to assess the vaccines’ safety and ability to generate a broad range of neutralizing antibodies against HIV. The two vaccine candidates, mRNA-1644 and mRNA-1574, are designed to combat HIV by inducing broadly neutralizing antibodies to levels not previously obtained by other shots. The antibodies can then target multiple variants of HIV and neutralize stable parts of the virus that won’t change as much as it mutates. The study, expected to run until May 2023, is a first step in a long, complex process, according to researchers.Researchers have discovered a series of drug compounds that are highly effective against the three main species of parasitic worms that cause human schistosomiasis, according to new research published in PLOS Neglected Tropical Diseases. Currently, the only treatment for schistosomiasis is praziquantel, which is effective at a high dose against adult worms, but less so against juvenile worms, requiring repeat treatment. The new research involved screening more than 300,000 compounds to evaluate their ability to kill the worms, compared against praziquantel. The researchers identified a series of promising new drug candidates that appeared safe and highly effective against adult and juvenile worms—in a single dose around 10 times smaller than required for praziquantel. The drugs are now being explored by Merck Global Health Institute as a potential treatment for schistosomiasis.In phase 3 trial results, AstraZeneca’s COVID-19 antibody treatment, AZD7442, significantly reduced the risk of developing COVID-19 symptoms. The drug, a combination of two long-acting antibodies, reduced the risk of developing symptoms by 77 percent when given to patients who had not been exposed to COVID-19. No participants who were given the treatment developed a severe form of the disease. The monoclonal antibodies used in AZD7442, which mimic the body's natural immune response, were modified to be more long-lasting, potentially affording up to 12 months of protection. The drug could be particularly useful as a preventative treatment in patients for whom vaccines might be less effective, including immunocompromised individuals, AstraZeneca said in its statement. The company plans to submit the phase 3 results to a peer-reviewed journal and file for regulatory approval of the drug.

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