Invivyd’s monoclonal antibody can cut the risk of contracting Covid-19 in both healthy and immunocompromised people, according to the latest exploratory analysis from a Phase 3 trial.
The biotech’s pemivibart currently has FDA emergency use authorization to prevent Covid-19 in moderately to severely immunocompromised people aged 12 or older, with the brand name Pemgarda. The new data suggest it can offer protection to an even broader population, Invivyd said.
The drug achieved an 84% relative risk reduction in Covid-19 cases measured by symptoms and PCR tests in 333 immunocompetent participants compared with placebo at 180 days. Less than 2% of subjects with healthy immune systems given the prophylactic got symptomatic disease versus 11.9% of the placebo group, according to a company release Tuesday.
In the other Phase 3 cohort of 298 subjects with a compromised immune system who were given pemivibart, only 3.7% experienced Covid-19, hospitalization or death. The cases of Covid-19 were mild to moderate in severity, the company said.
Invivyd plans to share the full data in an upcoming journal publication. In the meantime, the company said the results reinforce the safety and efficacy of pemivibart. The FDA has updated the face sheet on Pemgarda for healthcare providers with the exploratory analysis data.
In March, Jefferies analysts said they expect Pemgarda to make $300 million in sales this year.
The Covid-19 prophylaxis space has seen several important developments in recent months as drugmakers work to respond to emerging variants that have rendered previous options less efficacious. In May, AstraZeneca’s monoclonal antibody candidate sipavibart passed a Phase 3 test in more than 3,000 people, spurring discussions with regulators with an eye to approval. Sipavibart is meant to be a successor to the UK pharma’s blockbuster product Evusheld, which is not active against an Omicron subvariant.
In 2022, Pfizer’s oral antiviral Paxlovid — which is typically used for post-exposure prophylaxis — was found to not perform as well as hoped in people who are already vaccinated and in younger age groups. The full results from the vaccinated adult trial released in April confirmed the news, although the drugmaker says it is still confident about Paxlovid’s clinical profile.