Moderna Inc MRNA said Monday that it has submitted an investigational new drug application to the FDA, seeking the regulatory agency's consent to proceed with Phase 2 and late-stage studies of its novel coronavirus vaccine candidate mRNA 1273.
The forward progress is contingent upon the Phase 1 study conducted by the National Institute of Allergy and Infectious Diseases showing positive safety data.
Moderna said it has received initial feedback from the FDA on the study design for the Phase 2 trial, which is expected to commence in the second quarter. The study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 weeks apart, according to Moderna.
The dosages to be tested are 50 micrograms and 250 micrograms.
The study will enroll about 600 healthy participants, with 300 adults ages 18-55 and 300 older adults ages 55 and above, the company said. Moderna plans to follow the participants for 12 months after the second vaccination.
"Submitting this IND is an important next step in the clinical development of our mRNA vaccine against SARS-CoV-2, and we are moving rapidly to potentially address this global health emergency," Tal Zaks, Moderna's chief medical officer, said in a statement.
The IND for the Phase 1 study was filed by the NIAID, which is conducting the study on behalf of Moderna.
Moderna reiterated a previous timeline it provided for a Phase 3 study, which it said is likely to begin in fall 2020. The company also noted that funding from the Biomedical Advanced Research and Development Authority helped support the planning of the studies and will also support the late-stage clinical development, as well as the potential scale-up of vaccine manufacturing.
Moderna shares were down 0.16% at $47.97 at the time of publication Tuesday.
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