Drug maker AstraZeneca's antibody cocktail trial reduced risk of developing symptomatic COVID-19 by only 33 per cent, failing to meet the primary endpoint of Phase III trial.
The 'Storm Chaser' trial assessing the safety and efficacy of a long-acting antibody (LAAB) combination AZD7442 failed to meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 compared to placebo, the company said in a release.
The Phase III, randomised, double-blind, placebo-controlled, multi-centre trial was conducted in 59 sites in the UK and US with 1,121 participants. The participants were randomised in a 2:1 ratio to receive a single intramuscular (IM) dose of either 300mg of AZD7442 or saline placebo, administered in two separate, sequential IM injections.
"In the overall trial population, AZD7442 reduced the risk of developing symptomatic COVID-19 by 33 per cent compared to placebo, which was not statistically significant," the company said. AstraZeneca said it is conducting other studies of the medicine that could help clarify the findings.
"While this trial did not meet the primary endpoint against symptomatic illness, we are encouraged by the protection seen in the PCR negative participants following treatment with AZD7442. We await results from PROVENT, our pre-exposure prevention trial and TACKLE, our treatment trial in preventing more severe disease, to understand the potential role of AZD7442 in protecting against COVID-19," Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca said.
On March 16 this year, AstraZeneca had announced an extended agreement with the US government to supply up to 5,00,000 additional doses of AZD7442 for $205 million, contingent on AZD7442 receiving Food and Drug Administration's emergency use authorisation in post-exposure prophylaxis.
"Discussions regarding next steps with the US government are ongoing," the company said.
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