Research Roundup: Oral TB treatment shows positive results, AstraZeneca updates vaccine efficacy, and Pfizer launches trial on COVID-19 treatment pill
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A clinical trial of a new, all-oral treatment regimen for multidrug-resistant tuberculosis (TB) has stopped enrolling patients, on an earlier-than-expected timeline, after initial data showed positive results. The phase 2/3 trial, TB-PRACTECAL, is evaluating a six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin, which an independent data safety and monitoring board found has already shown itself, through interim data, to be superior to current standard TB care. TB-PRACTECAL will be the first multi-country, randomized controlled clinical trial to report on the safety and efficacy of such a treatment, which has the potential to save thousands of lives and improve quality of life. Médecins Sans Frontières, which is sponsoring the trial, announced the findings last Wednesday on World TB Day and said it would share the trial data with the World Health Organization and submit full results to a peer-reviewed journal in the coming months.
On Wednesday, AstraZeneca announced that its COVID-19 vaccine has 76 percent efficacy at reducing the risk of symptomatic COVID-19 infection and 100 percent efficacy against severe disease, in an updated analysis of its phase 3 US-based clinical trial. The new findings came two days after an earlier analysis was flagged by the trial’s data and safety monitoring board as potentially based on incomplete information; updated results ultimately reduced the overall efficacy estimate by just three percentage points and did not impact the reported efficacy against severe disease. AstraZeneca has said it will publish the results in a peer-reviewed medical journal and submit for emergency use authorization in the United States.
Pfizer is beginning a clinical trial for an oral pill to treat COVID-19, building on antiviral technology that has been used against a range of infections including HIV and hepatitis C. The early-stage US trial will evaluate the drug, known as PF-07321332, which will be administered to patients as soon as they see signs of infection. The treatment, a protease inhibitor, is intended to dampen the virus’s ability to cause severe disease and death. As an oral pill, PF-07321332 would be able to be prescribed and taken outside of a secondary care setting, rather than infusion clinics or hospitals that have been necessary for several existing COVID-19 antibody treatments.