Adagio's COVID-19 Antibody Meets Primary Goals Across Pre & Post-Exposure Prophylaxis, Treatment

Adagio Therapeutics Inc's ADGI Phase 2/3 trials evaluating 300 mg adintrevimab (ADG20) as pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19 have met its primary endpoints.
Following the emergence of the omicron variant, a pre-specified exploratory analysis in a subset of the pre-exposure cohort, adintrevimab exhibited a clinically meaningful reduction in cases of symptomatic COVID-19 compared to placebo.
The risk of symptomatic COVID-19 was reduced by 71% compared to placebo in pre-exposure prophylaxis and 75% in post-exposure prophylaxis.
In the STAMP study, adintrevimab demonstrated a 66% relative risk reduction. One death (0.6%) was in the adintrevimab group, compared with six deaths (3.6%) in the placebo group.
Related: Adagio Lays Out Development Plans For COVID-19-Focused ADG20 Program.
In patients treated within three days of symptom onset, adintrevimab reduced the risk of COVID-19 hospitalization or death by 77% compared to placebo.
Adagio plans to submit an FDA Emergency Use Authorization application in Q2 of 2022 for adintrevimab to prevent and treat COVID-19.
In addition, preliminary safety data through two weeks post-dosing suggest a favorable safety profile at the 1200mg dose.
Re-engineered variants of ADG20 show over 100-fold improvement in binding and up to 40-fold enhanced neutralizing activity against the omicron BA.1 variant while maintaining activity against all other variants of concern.
Adagio closed 2021 with cash, cash equivalents, and marketable securities of $591.4 million, sufficient to fund its expenses into the 2H of 2024.
Price Action: ADGI shares 45.70% at $5.61 during the market session on the last check Wednesday.

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