Supply constraints loom as Regeneron reports positive data on COVID-19 mAb
Lilly announces $375M U.S. mAb purchase contract
Days before FDA is expected to decide about their emergency use authorization requests, Regeneron released new data confirming the efficacy of its COVID-19 mAb cocktail and Lilly announced that the U.S. government has contracted to purchase its mAb.
The cocktail from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) met the study’s first nine endpoints. In addition to meeting virologic endpoints, REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 overall and 72% in patients with one or more risk factor.
The data are overshadowed by supply constraints. The company will be able to provide the U.S. government, which has contracted to purchase its entire supply, only 50,000 doses year-end. Manufacturing will ramp up in 2021.
Demand in the U.S. for COVID-19 mAbs could exceed 12,000 doses per day, according to former FDA commissioners Scott Gottlieb and Mark McClellan.
Regeneron had previously released a “descriptive analysis” based on the first 275 patients treated with its REGN-COV2 plus standard-of-care compared with adding placebo to standard-of-care.
On Wednesday, Regeneron provided data on an additional 524 patients in the Phase II/III study. The first nine endpoints evaluated virologic endpoints based on viral load, seronegative status and dose group, plus the clinical endpoint of COVID-19 related, medically-attended visits, in patients with laboratory-confirmed COVID-19 at baseline.
There was no significant different between high dose (8 grams) and low dose (2.4 grams), leading Regeneron to announce that it is assessing possible changes to dosing in the ongoing outpatient clinical trial due to the limited supply of REGN-COV2.
Virologic results in the 524 patients reported Wednesday include success in the primary endpoint, average daily change in viral load through day seven following infusion in patients with high viral load (defined as greater than 107 copies/mL). There was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared with placebo (combined dose groups; p<0.0001). At day five, those who received REGN-COV2 had “on average, a greater than 10-fold reduction in viral load, compared to placebo,” the company said.
Eli Lilly and Co. (NYSE:LLY) has signed an agreement to sell the U.S. government 300,000 vials of bamlanivimab (LY-CoV555), a COVID-19 mAb, for $375 million. The deal covers two months following an emergency use authorization.
Lilly’s EUA request is based on interim Phase II data in which the middle of three doses of bamlanivimab met the co-primary endpoint of reducing viral loads at day 11 from baseline levels in mild-to-moderate COVID-19 patients.
NIH recently ended a Phase II trial comparing bamlanivimab plus remdesivir to remdesivir alone to treat hospitalized COVID-19 patients after a DSMB determined that there was little chance that the mAb could be effective in the indication.
Speaking on a streamed interview with JAMA Wednesday, Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), said the trial failure underscores the importance of administering antiviral therapies to COVID-19 patients “early before someone gets advanced disease.”
The U.S. government has an option to purchase up to 650,000 vials of bamlanivimab through June 30, 2021. Lilly said it is partnering with governments and philanthropic organizations to allocate limited supply of its COVID-19 mAbs globally.
Bamlanivimab was discovered by AbCellera Biologics Inc. and co-developed by the Vaccines Research Center at NIAID. AbCellera developed rapid antibody discovery capabilities as part of a U.S. Defense Research Advanced Projects Agency (DARPA) program.