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Thursday, January 13, 2022 2:02:27 AM
Jan. 12, 2022 5:22 PMAdagio Therapeutics, Inc. (ADGI)By: Ravikash, SA News Editor
a corona virus omicron variant composition
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Adagio Therapeutics (NASDAQ:ADGI) said three separate publications that show that its lead monoclonal antibody (mAb) ADG20 has neutralization activity against the Omicron (B.1.1.529) variant of SARS-CoV-2, and outlined initiatives to address current and future SARS-CoV-2 variants of concern.
The company is evaluating ADG20 in its global Phase 2/3 trials for both the prevention and treatment of COVID-19.
Adagio said it is engaging with the U.S. Food and Drug Administration (FDA) regarding potential protocol updates to its global phase 2/3 trials, including an increased dose of ADG20 for the potential prevention and treatment of COVID-19 resulting from the Omicron variant.
The company said findings across all three studies show that among mAbs in late-stage clinical development or with Emergency Use Authorization (EUA), ADG20 is one of only a few mAbs that demonstrated neutralizing activity against Omicron. Across two distinct authentic neutralization assays against Omicron, the data show that ADG20 had an IC50, a measurement of neutralization potency, of approximately 0.4 to 1.1 µg/mL, which is comparable with the two other active mAbs, sotrovimab and AZD7742.
"While findings may show that ADG20 has reduced potency against Omicron when compared to its high potency against all other variants of concern, including Delta, the data support that ADG20 is among the few mAbs to demonstrate neutralizing activity against the Omicron variant and warrants its continued development,” said Laura Walker, Ph.D., chief scientific officer and co-founder of Adagio.
The company added that it is continuing evaluation of ADG20 in its EVADE and STAMP trials and engaging with the FDA on dosing strategy, including an increased dose of ADG20 and other protocol updates.
Adagio noted that it is pausing the enrollment of new patients in the 300 mg dose arm in both trials as the company updates its protocols. Follow-up and monitoring of patients previously administered ADG20 are continuing per the original protocols.
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