The company said on Friday that 75% of the participants in the trial for the therapy – two types of antibodies discovered by Vanderbilt University Medical Center – had chronic conditions including some with a lower immune response to vaccinations.

Similar monoclonal antibody therapies are being developed by Regeneron, Eli Lilly and GlaxoSmithKline with partner Vir.

But AstraZeneca is the first to publish positive COVID prophylaxis data from an antibody trial.

The good news on the therapy was tempered, however, by a separate AstraZeneca statement (https://bit.ly/3y4iinJ) on Friday.

It said a trial of a treatment for the rare neurological disorder amyotrophic lateral sclerosis (ALS), developed by AstraZeneca’s newly acquired Alexion, had been stopped early due to a lack of efficacy.

AstraZeneca executive Mene Pangalos said the therapy trial results were taken three months after the antibodies were injected and investigators would follow up as far out as 15 months in the hope the company can tout the shot as a year-long shield.

Pangalos signalled that the prospects of a new COVID-19 product in AstraZeneca’s medicine cabinet could also enhance the strategic value of its existing vaccine Vaxzevria, which it developed in collaboration with Oxford University.

“No other company has delivered two molecules against SARS-CoV2. This definitely helps us in positioning us in terms of COVID,” Pangalos told Reuters.

Another leading AstraZeneca executive, Ruud Dobber, had said last month that different strategic options were being explored for AstraZeneca’s vaccine operations, which have faced a string of challenges.

APPROVAL TARGETS

The Anglo-Swedish drugmaker has suffered production problems during the rollout of Vaxzevria while very rare cases of blood clotting have weighed heavily on demand for the shot in Europe. The vaccine has also yet to win clearance in the United States.

The immunocompromised, such as those with organ transplants or in cancer care, make up about 2% of the population and would be the main target group for the new therapy. Naval forces on missions could also benefit, among others, Pangalos said.

Even though only 12% to 13% of the trial volunteers were vaccinated when the therapy trial data was generated, AstraZeneca will seek to position the shot as a top-up to previous inoculations.

Pangalos said AstraZeneca was targeting conditional approval in major markets for the therapy well before year-end and that roughly 1 to 2 million doses would be produced by then.

Any bulk supply contracts would prompt the company to boost production, with one or two manufacturing sites at as-yet undisclosed locations serving world demand, he said.

Nguồn tin: Reuters Health Information © 2021