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Invivyd Announces PEMGARDA™ (pemivibart) Demonstrated 84% Relative Risk Reduction in Symptomatic COVID-19 Compared to Placebo in an Exploratory Analysis from Ongoing CANOPY Phase 3 Clinical Trial
In all-comer cohort of immunocompetent individuals at risk of contracting symptomatic COVID-19 in their everyday social interactions, participants receiving
About this update from Invivyd, Inc.
[{"type":"text","content":"In all-comer cohort of immunocompetent individuals at risk of contracting symptomatic COVID-19 in their everyday social interactions, participants receiving pemivibart experienced a 1.9% rate of confirmed symptomatic COVID-19 compared to an 11.9% rate for participants receiving placebo, an 84% relative risk reduction (nominal p= 0.000061)In immunocompromised participants, pemivibart demonstrated a rate of 3% of confirmed symptomatic COVID-19, an encouraging potential signal of protection during the assessed time periodCANOPY data from planned exploratory clinical efficacy analyses during the 180-day period that included XBB* and JN.1* virus lineages Safety profile of pemivibart consistent with previously reported CANOPY clinical trial dataPEMGARDA (pemivibart) Fact Sheet for Healthcare Providers updated by U.S. Food and Drug Administration (FDA) including exploratory clinical efficacy data Conference call today at 8:30AM EDT to discuss CANOPY data analyses WALTHAM, Mass., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced positive 180-day exploratory clinical efficacy data from the company’s ongoing CANOPY Phase 3 clinical trial of pemivibart, a half-life extended investigational monoclonal antibody (mAb), for the pre-exposure prophylaxis (PrEP) of COVID-19. The exploratory clinical efficacy data in Cohort B, a placebo-controlled cohort of all-comer immunocompetent individuals, showed a relative risk reduction of 84% with pemivibart compared to placebo in the likelihood of trial participants contracting confirmed symptomatic COVID-19, with no hospitalizations or deaths due to COVID-19 reported. Cohort B participants treated with pemivibart experienced a 1.9% rate of symptomatic COVID-19 across a 180-day time period, whereas Cohort B participants in the placebo arm experienced an 11.9% rate of symptomatic COVID-19, a robust attack rate for the trial. Cases of COVID-19 observed in the pemivibart arm were mild or moderate in severity. Additionally, in Cohort A, the single-arm immunocompromised cohort of the trial, pemivibart demonstrated a 3% rate of confirmed symptomatic COVID-19 over the 180-day period. Cases of COVID-19 observed in this cohort were also mild or moderate in severity. These exploratory ...