COVID-19 Update #49 for 11/4/2020
Novavax had enrolled 5.500 patients by the end of October 2020 in a Phase III British trial and increased the total number in the trial to 15,000. The company expects to complete enrollment by the end of November 2020. Novavax plans to enroll 30,000 patients in a Phase III, Operation Warp Speed sponsored trial, in the U.S. and Mexico. Due to delays in scaling up vaccine manufacturing, the initiation of the trail is expected to begin at the end of November.
CureVac reported that in a 250 patient, Phase I dose ranging trial (NCT04449276), a 12 mcg dose of its COVID-19 vaccine, CVnCoV, elicited antibody levels similar to levels seen in a group of recovered COVID-19 patients after a second dose of the vaccine. In the Phase I trial, healthy patients were randomized to doses of 2, 4, 6, 8 and 12 mcg on days 1 and 29. The 12 mcg dose was chosen for future trials.
Interim results from 452 patients enrolled in the Phase II, dose-ranging BLAZE-1 trial (NCT04427501), found that on day 11, there was a significant decrease in viral load with bamlanivimab 2,800 mg, but non-significant decreases with 700 mg and 7,000 mg. Among secondary endpoints, COVID-19 symptoms from days 2 through 6 were less severe with bamlanivimab than placebo and hospitalizations on day 29 were also significantly lower (1.6% vs. 6.3%).
The U.S. government will pay Lilly $375 million for 300,000 doses of bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients. The doses are to be delivered after an EUA is granted. There is an option to purchase up to 650,000 vials through June 30, 2021, which would correspond to an additional $812 million. Lilly set WAC at $1,250 per vial for bamlanivimab. The number of doses available for bamlanivimab will depend on the approved dose. The current calculation is based on a 700 mg dose, but if a 2,800 mg dose is used, the number of doses will significantly lower.
Regeneron provided an update from the first 799 patients enrolled in a 1,300 patient, adaptative Phase I/II/III trial (NCT04425629), where treatment with REGN-COV2 lowered viral levels through day 7 to a greater extent at increasing viral loads. The monoclonal antibody appeared to be more efficacious in patients that had not produced antibodies and/or had higher viral loads. Treatment with REGN-COV2 reduced COVID-19 related medical visits compared to placebo (2.8% vs 6.5%).
Regeneron held enrollment of hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation on 10/30/2020 at the recommendation of the independent data monitoring committee (IDMC) due to a potential safety signal and an unfavorable risk/benefit profile. The IDMC recommended continuing enrollment of hospitalized patients requiring either no or low-flow oxygen. The Phase I/II trial is evaluating REGN-COV2 in the treatment of COVID-19 in 1,860 hospitalized patients (NCT04426695).
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