A New Dawn in COVID Defense: PEMGARDA's Landmark Trial Unveils Powerful Protection!
- Shields Up! PEMGARDA dramatically cut symptomatic COVID-19 risk by an astounding 84% in a modern U.S. population battling today's immune-evasive Omicron variants1, 2, 5.
- First of its Kind: The CANOPY trial, a groundbreaking placebo-controlled study, proves monoclonal antibody might in individuals already exposed to COVID-19 through infection or vaccination1, 5.
- Hope for the Vulnerable & Beyond: This breakthrough offers a vital new defense for immunocompromised individuals and crucial protection for everyday Americans at ongoing risk5.
WALTHAM, Mass. – As SARS-CoV-2 continues its relentless evolution, evading prior defenses and posing an ongoing threat, Invivyd today unveiled game-changing results from its CANOPY Phase 3 clinical trial of PEMGARDA® (pemivibart). Published in a leading peer-reviewed journal, these findings herald a new era of protection, particularly for those most vulnerable5.
This isn't just another study. CANOPY is the only clinical trial of an authorized or approved COVID-19 monoclonal antibody or vaccine to demonstrate such compelling efficacy in a placebo-controlled cohort of contemporary, immunologically experienced Americans facing modern, shape-shifting Omicron viruses1. Over a grueling year of substantial COVID-19 transmission (Sept 2023 - Sept 2024), PEMGARDA stood strong. The trial, involving 788 adults, including immunocompromised individuals (Cohort A) and those at risk from regular indoor interactions (Cohort B), met all its goals5.
The results are striking: an 84% relative risk reduction in symptomatic COVID-19 compared to placebo at six months for Cohort B – ordinary Americans taking regular, unmasked, face-to-face meetings1, 2, 5. Only a mere 2% of PEMGARDA recipients developed symptomatic COVID-19 by month six, versus nearly 12% on placebo2, 7. This robust protection impressively endured over twelve months without additional dosing2.
"Most people... are not aware that COVID-19 killed more Americans last year than breast cancer or car accidents," warned Dr. Cameron R. Wolfe of Duke University5. He emphasized the unacceptable burden on the immunocompromised, stating the CANOPY results "should make it very clear to clinicians that they can now attack the COVID-19 burden for immunocompromised patients directly."
PEMGARDA was generally well-tolerated, though anaphylaxis, a serious allergic reaction, was observed in 4 of 623 participants receiving the drug (0.6%, 2 serious), a known risk for which PEMGARDA carries a boxed warning1, 7. These results supported the FDA's Emergency Use Authorization (EUA) for PEMGARDA for pre-exposure prophylaxis in certain immunocompromised individuals5, and it's already included in NCCN® guidelines for some high-risk cancer patients4.
Invivyd sees this as validation for a "more natural and equitable, additive form of immunity"5 and aims to leverage these findings to expedite future antibody innovations, like VYD2311, potentially offering even more patient-friendly administration5. This landmark achievement not only offers immediate hope but also paves the way for a future where monoclonal antibodies are a cornerstone of defense against evolving viral threats4, 5.
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