Monoclonal-antibody drug reduced hospitalization or mortality from Covid-19 by 85% compared to placebo in a clinical trial, Vir Biotechnology Inc said. and GlaxoSmithKline PLC, developers of the drug.
Based on the positive results, the companies said Wednesday that they will immediately ask health regulators in the U.S. and other countries to approve the treatment, which would be added to Covid-19’s arsenal of medicines that help keep infected people out of ospadalan.
If authorized, the drug would be the fourth antibody drug available in the U.S. after ones made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. President Donald Trump then proposed Regeneron for his cure, but the drugs were used sparingly.
Vir and Glaxo said an independent investigative committee recommended that the investigation be stopped early because an interim review of data from 583 study subjects showed that the drug, known as VIR-7831, had semi-effective.
“We look forward to the possibility of making VIR-7831 available to patients as soon as possible and to further explore its potential in other settings,” said Hal Barron, chief executive Glaxo scientific officer and president of research and development.
The companies did not reveal detailed survey results, such as the percentage of patients who were hospitalized or who died.
Study volunteers will be monitored for 24 weeks, and more data will be released after the study is completed, the companies said. The study evaluates patients with mild or moderate Covid-19 symptoms who are at high risk of developing severe disease.
Monoclonal antibodies are the only treatments authorized for patients early in the course of a disease who are at high risk of hospitalization. However, many of the available doses have not been used due to the supply challenges posed by the drugs for hospitals, such as locating space and staff to monitor the intra- take.
Some patients have said that it is difficult to find treatment sites to get the drugs. In response, HHS, Eli Lilly and Regeneron have supported online infusion site search engines.
Nationwide, 34% of the doses dispensed to states are given to patients, a spokesman for the Department of Health and Human Services said last week.
Vir and Glaxo reported that a separate study of VIR-7831 showed that it remains effective against new coronavirus mutations identified in the UK, South Africa and Brazil that scientists are concerned may have against monoclonal antibody drugs.
A scientific paper detailing the results of the variable study will be published online on a so-called preprint server, the companies said. Preprint servers are used to distribute search results before they are published in peer-reviewed journals.
“These findings, together with our forthcoming publication of countermeasures data, demonstrate the ability of VIR-7831 to prevent the hardest consequences of Covid-19 and highlight its potential to could protect against the virus ‘normal circulation cycles, “said Government Chief George Scangos’ s Vir.
Write to Joseph Walker at [email protected]