- An experimental antibody treatment from AstraZeneca reduced the risk of severe COVID-19 by 50% in patients with mild or moderate disease in a Phase 3 trial, a new result that helps solidify the drug's benefits after mixed findings in two other large tests.
- The trial, called TACKLE, compared a placebo to a single intramuscular injection of AstraZeneca's treatment in adults who had COVID-19 symptoms for a week or less but weren't hospitalized. Thirty-seven of the 415 patients who got a placebo developed severe COVID-19 or died, versus 18 of 407 treated with AstraZeneca's drug, which was was "generally well tolerated," the company said.
- The result builds on evidence showing AstraZeneca's treatment can help prevent the onset of COVID-19 symptoms in people exposed to infections, strengthening the company's case to regulators in the U.S. and elsewhere. But other antibody drugs have had similar benefits, and new competition could soon emerge in the form of antiviral pills for COVID-19.
In some ways, AstraZeneca's COVID-19 response has been as good as any in the biopharmaceutical industry.
The British drugmaker licensed and developed an effective COVID-19 vaccine, for instance, that's been authorized in dozens of countries and administered to millions of people — a success only a few other drugmakers can claim.
And now AstraZeneca has followed up with an antibody drug that appears able to both prevent COVID-19 and treat active infections. If the drug, known as AZD7442, is cleared by regulators, AstraZeneca would be the only pharmaceutical company so far with both a marketed vaccine and treatment for COVID-19.
But AstraZeneca nonetheless trails several of its peers in the COVID-19 fight. The initial rollout of the company's shot in Europe was slowed by communication missteps and the emergence of a rare but serious side effect. The vaccine still hasn't been authorized in the U.S., and though cross-trial comparisons can be difficult, has appeared less potent than the messenger RNA shots from Pfizer and Moderna. Revenue from those shots have far outpaced the sales AstraZeneca's vaccine has generated, although that in part is the result of the UK drugmaker's decision to sell it at cost.
Now AstraZeneca's antibody drug faces an uphill battle. It stands to become at least the fourth of its kind cleared for use, following similar drugs from Regeneron, Eli Lilly and Vir Biotechnology. And while use of infusible or injectable antibody drugs has spiked amid the spread of the delta variant, their utility will be tested by Merck & Co. and Ridgeback Biotherapeutics' pill molnupiravir, which could soon become the first oral treatment for COVID-19.
AstraZeneca, for its part, is leaning on two key features of AZD7442. The drug is a combination of two antibodies, a strategy that's proven helpful in neutralizing coronavirus variants like delta. AstraZeneca's antibody also lasts at least six months and can be administered through a single intramuscular injection. In its announcement, for example, AstraZeneca called its drug the "only long-acting antibody combination shown to prevent and treat COVID-19."
Yet the other marketed COVID-19 antibody drugs each have some of those elements. Regeneron and Eli Lilly both have dual-acting antibodies, for example, and Regeneron's — which has proved potent in lab tests against several variants — can be given through an injection or an infusion. Vir's treatment was modified to last longer.
AstraZeneca filed for emergency authorization in the U.S. on Oct. 5.