Moderna, a biotechnology company, has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational Zika vaccine, mRNA-1893.
At present, the mRNA-1893 vaccine is being assessed in a phase 1 study to prevent Zika virus infection in healthy adults.
The mRNA-1893 included an mRNA sequence that encodes for the structural proteins of Zika virus. It is designed to help cells to secrete virus-like particles, helping to mimic the response of the cell after natural infection.
The phase 1 trial is assessing the safety, pharmacokinetics and pharmacodynamics of mRNA-1893 in healthy volunteers.
Moderna’s randomised, observer-blind, placebo-controlled and dose-ranging study has been framed to assess the safety, tolerability and immunogenicity of mRNA-1893 in healthy flavivirus seropositive and seronegative adults aged between 18 and 49 years.
According to the company, primary outcome measures comprise of frequency and grade of adverse events, while secondary outcome measures include geometric mean titers of neutralising antibodies against Zika virus.
Earlier, Moderna secured fast track designation for its methylmalonic acidemia (MMA) programme, mRNA-3704, which is currently enrolling patients under the phase 1/2 clinical study.
Moderna chief medical officer Dr Tal Zaks said: “Protecting against Zika virus transmission, particularly in women during pregnancy, continues to be an area of high unmet need. Fast Track designation supports our belief in the clinical potential of mRNA-1893 and the importance of developing an effective vaccine that can be rapidly developed and deployed.
“Our Zika program is part of Moderna’s broader commitment to improving global public health through developing mRNA vaccines to prevent the spread of infectious diseases.”
Based in Cambridge of Massachusetts, Moderna is focused on advancing messenger RNA (mRNA) science for the development of a new class of medicines for patients.
The company has strategic collaborations for programmes with AstraZeneca and Merck, as well as the US Department of Defence’s Defence Advanced Research Projects Agency (DARPA) and division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS).
In January 2018, Takeda Pharmaceutical secured fast track designation from FDA for its Zika virus vaccine candidate, TAK-426.