The medicine reduced the risk of developing symptomatic Covid in high-risk people by 83% in one of the trials after a six-month follow-up, the company said Thursday. The other one, which involved outpatient participants with mild to moderate illness, found the cocktail cut the risk of severe disease or death by 88% if given within three days.
The results pointed to better protection than the initial data even as the delta variant surged, a relief for the British drugmaker after a shaky start. Astra's first trial failed to prevent symptomatic disease in people explicitly exposed to the virus. The company applied for U.S. emergency authorization for the product in the prevention setting last month and has a deal to deliver 700,000 doses to the country if cleared.
The U.K. has started an expedited review of the drug, and Astra plans to file for authorization in the European Union shortly. The product, which is delivered via an injection, will be priced commercially but the company will ensure it's "affordable," Iskra Reic, head of Astra's new vaccines and immune therapies unit, told reporters Thursday.
"At the end of the day, our premium objective is to ensure broad access to patients who have a need," Reic said.
The data from both trials -- known as Provent and Tackle -- add to positive outcomes reported earlier this year. Astra also plans to do a pediatric trial for the monoclonal antibody, according to Chief Executive Officer Pascal Soriot.
The Provent trial was designed specifically for people who may not respond adequately to vaccines, such as transplant patients and those undergoing chemotherapy. There were no cases of severe Covid-19 or related deaths among those receiving the drug in those tests. In the placebo arm, five people developed severe versions of the disease and two died, the company said.
The Tackle outpatient trial also focused on those at risk of severe disease with conditions including cancer, diabetes and obesity. About 52% of participants identified as Hispanic or Latino. Both trials found the cocktail was generally well-tolerated.
An initial readout from the Provent trial in August showed the drug prevented symptomatic disease in high-risk individuals by 77%. In results published in October from the Tackle trial, the drug was shown to halve the risk of mild to moderate disease worsening if given within seven days of symptoms.
The data indicate that the drug can provide "my vulnerable patients with the long-lasting protection they urgently need," Hugh Montgomery, professor of intensive-care medicine at University College London and principal investigator on the the trial, said in a statement.
Published : November 18, 2021
By : Bloomberg