- The National Institutes of Health has stopped enrollment into a clinical trial testing Vir Biotechnology's COVID-19 antibody drug in hospitalized patients after independent review "raised concerns about the magnitude of potential benefit," the company reported Wednesday. Shares in the California-based biotech tumbled 28%.
- The planned analysis took place after the first 300 patients were enrolled and researchers found no safety concerns to adding the drug to standard of care treatment, including Gilead's Veklury. Vir, along with partner GlaxoSmithKline, said it will continue to review the data with NIH officials to assess its potential in treating hospitalized patients.
- The Food and Drug Administration has authorized synthetic antibodies from Regeneron and Eli Lilly for high-risk COVID-19 patients who are not yet sick enough to be hospitalized. Vir is also testing its drug in non-hospitalized patients, both as monotherapy and in combination with Lilly's bamlanivimab.
While public health authorities continue to roll out coronavirus vaccines, tens of thousands of people are still falling ill and thousands are sick enough to need hospital treatment in the U.S. each day. So drugs to treat those people are still needed, and will be in the future as vaccination may not be universal.
For hospitalized patients, dexamethasone and Gilead's Veklury have been shown to prevent death or to shorten hospital stays. For infected patients at high risk of severe disease, both Regeneron and Eli Lilly have won FDA clearance for synthetic antibodies that target the SARS-CoV-2's characteristic "spike" protein, much as the vaccines seek to stimulate an immune response.
Vir, along with GlaxoSmithKline, had hoped VIR-7831 would be able to join dexamethasone and Veklury in treating hospitalized patients. In the NIH-led ACTIV-3 trial, patients were given a background therapy of Veklury and dexamethasone or other corticosteroids, and then received either VIR-7831 or a placebo.
While the company's statement didn't disclose any detailed data, it suggests the data review revealed limited added benefit over Veklury and corticosteroids. As a result, the NIH will cease enrollment in the VIR-7831 arm "while the data mature," Vir said in its release.
For GSK, this represents another in a series of setbacks surrounding its COVID-19 strategy. On vaccines, GSK shared its immune-boosting adjuvants with Sanofi, Chinese company Clover Biopharmaceuticals and Canada's Medicago, and for drugs it partnered with Vir.
The vaccine GSK developed with Sanofi has been slowed by weaker-than-expected early stage testing, while Clover selected an adjuvant made by Dynavax. The Medicago vaccine is progressing, however. More recently the British drugmaker partnered with CureVac to make second-generation COVID-19 vaccines.