Invivyd Announces Positive 180-day Clinical Efficacy Data From CANOPY Phase 3 Trial Of Pemivibart

(RTTNews) - Biopharmaceutical company Invivyd, Inc. (IVVD) announced Tuesday positive 180-day 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 data support the concept of potential protection observed with pemivibart, aligned with expectations of a highly active prophylactic monoclonal antibody in this population.

The safety profile of pemivibart in the second half of the assessed 180-day time period remained consistent with previously disclosed CANOPY clinical trial data.

The 180-day clinical efficacy exploratory data announced today complements the initial clinical efficacy exploratory data demonstrating potential signals of clinical protection from symptomatic COVID-19 shared previously.