Regeneron, riding the crest of a wave after its anti-Covid-19 antibody combo REGN-COV2 got US presidential endorsement, has moved to put flesh on the bones of an earlier clinical “descriptive analysis”. The group yesterday said that with 799 patients now treated in Study 2067 REGN-COV2 has been shown to cut medical visits, which it called a key clinical endpoint. Earlier disclosure from this ambulatory subject trial related to the first 275 enrolled across two dose groups, and showed viral load reductions that were greatest in patients with the highest load at baseline. These are two of the study’s five primary measures, and Regeneron says all of the first nine endpoints in the statistical hierarchy have been met. The 57% reduction in hospital visits versus placebo looks impressive, though the absolute numbers are small: 2.8% of REGN-COV2 treated patients had a visit versus 6.5% of placebo recipients, which likely translates into just 30 total visits across the three-cohort trial. But they will bolster Regenron’s case for emergency use authorisation, for which it applied earlier this month. Lilly's rival bamlanivimab, which recently failed in hospitalised patients, has also been filed for EUA.
|Selected trials of MAbs against Covid-19|
|Blaze-1, ambulatory patients||Bamlanivimab +/- etesevimab||Lilly||Hospital visits: 0.9% for combo vs 5.8% for placebo (p=0.049 in earlier analysis), 1.6% for monotherapy vs 6.3% for placebo (NEJM update, no stats)|
|Study 2067, ambulatory patients||REGN-COV2 (REGN10933 + REGN10987)||Regeneron||Hospital visits: 6.5% for placebo, 2.8% for combo (p=0.024)|
|Activ-3, hospitalised patients||Bamlanivimab + Veklury||NIAID||Failed to show benefit|
|Study 2066, hospitalised patients||REGN-COV2 (REGN10933 + REGN10987)||Regeneron||Primary completion Jan 2021|
|Note: bamlanivimab = LY3819253 or LY-CoV555; etesevimab = LY3832479 or LY-CoV016. Source: company presentations, NEJM & clinicaltrials.gov.|