Invivyd: PEMGARDA™ Shows 84% Lower Symptomatic COVID-19 Risk vs. Placebo in Phase 3 Trial

Invivyd, Inc., a biopharmaceutical company based in Waltham, Massachusetts, has announced promising 180-day exploratory clinical efficacy data from its ongoing CANOPY Phase 3 clinical trial of pemivibart. Pemivibart is an investigational monoclonal antibody (mAb) designed for pre-exposure prophylaxis (PrEP) of COVID-19.

The data revealed that participants in Cohort B, which included all-comer immunocompetent individuals, showed an 84% relative risk reduction in contracting symptomatic COVID-19 when treated with pemivibart compared to those given a placebo. Specifically, 1.9% of participants receiving pemivibart developed symptomatic COVID-19 over the 180-day period, compared to 11.9% of those in the placebo group. None of the participants in this cohort reported hospitalizations or deaths due to COVID-19, and cases were generally mild to moderate.

In addition, Cohort A, which consisted of immunocompromised individuals, demonstrated a 3% rate of confirmed symptomatic COVID-19 after treatment with pemivibart. This provides a potential indication of protection in a population at higher risk of severe disease. COVID-19 cases in this cohort were also mild to moderate in severity.

The safety profile of pemivibart remained consistent with previous safety data from the CANOPY trial. In Cohort A, the most common treatment-emergent adverse events (TEAEs) included viral infections, upper respiratory tract infections (URTI), influenza-like illnesses, infusion-related reactions, and urinary tract infections. Anaphylaxis was reported in four participants, leading to the discontinuation of the drug. Systemic infusion-related reactions and hypersensitivity reactions were generally mild to moderate and occurred within 24 hours of dosing.

In Cohort B, common TEAEs were similar between the pemivibart and placebo arms, with upper respiratory tract infections, viral infections, and influenza-like illnesses being the most frequently reported. No anaphylaxis cases were observed, and systemic infusion-related reactions and hypersensitivity reactions were mostly mild to moderate.

The CANOPY clinical trial was conducted during a period marked by the circulation of various SARS-CoV-2 variants, including XBB and JN.1 lineages. Participants received two doses of pemivibart or placebo via intravenous infusion three months apart. The trial assessed safety, serum virus-neutralizing antibody titers, and clinical endpoints over the 180-day period.

These exploratory data complement earlier findings and suggest that pemivibart could provide meaningful protection against symptomatic COVID-19, even in populations with previous exposure to the virus through vaccination or natural infection. The company plans to publish the full dataset in a scientific journal.

The updated PEMGARDA Fact Sheet for Healthcare Providers now includes this exploratory clinical efficacy data. PEMGARDA (pemivibart) has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) for the pre-exposure prophylaxis of COVID-19 in individuals with moderate to severe immune compromise who are unlikely to mount an adequate immune response to vaccination. However, it is not authorized for the treatment of COVID-19 or post-exposure prophylaxis.

Invivyd aims to innovate new molecules and educate the clinical community on the potential of monoclonal antibodies to provide strong protection against COVID-19. The company remains committed to addressing serious viral infectious diseases and ensuring broader access to these medical advancements.