Regeneron announced yesterday that it had initiated late-stage clinical trials to assess REGN-COV2, an investigational double antibody cocktail, for the treatment and prevention of COVID-19.
The move will see both a Phase III trial and a Phase II/III trial go ahead to determine whether the potential treatment can prevent infection among uninfected people, and whether it is able to treat patients with COVID-19.
The company’s shift into late-stage trials follows a positive review of its Phase I study of 30 hospitalized and non-hospitalized patients with COVID-19.
Regeneron stated that the trials will take place across 150 sites in the US, Brazil, Mexico and Chile, with preliminary data expected ‘later this summer’.
Funding for manufacture
This news was immediately followed up today, when the US government announced that it would be supporting Regeneron’s efforts to develop the antibody cocktail by aiding the scale up of manufacture.
Regeneron already revealed that it would devote its entire New York, US, facility to the manufacture of the potential treatment – with the potential to manufacture approximately a million doses per month.
The US government will now work with the company to allow for the commercial-scale manufacture of the investigational treatment, in return for ownership of the doses that are produced as part of the project.
In total, the Biomedical Advanced Research and Development Authority (BARDA) will provide $450m (€398m) that will allow for the production of between 70,000 and 300,000 treatment doses.
Regeneron estimates that the doses could be made available by the ‘end of summer’, with the project completed by the end of fall.
The work required to achieve this will be carried out at the same time as the aforementioned late-stage clinical trials. Should the clinical trials prove the efficacy of the treatment, the doses of medicines will be packaged and ready for distribution immediately, the US government stated.