Moderna Therapeutics Inc (NASDAQ:MRNA) shares have fallen more than 5% in pre-market trading after the biotechnology company reported mixed results from a study of its experimental influenza (flu) vaccine mRNA-1010.
The Phase 3 randomized trial was designed to evaluate and safety and immunogenicity of mRNA-1010 in adults aged 18 and older in the Southern Hemisphere.
Moderna said interim results indicated that mRNA-1010 achieved superiority on seroconversion rates for two of the four flu strains targeted, A/H3N2 and A/H1N1, as well as superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1.
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However, the vaccine was found inferior for both endpoints for the influenza B/Victoria- and B/Yamagata-lineage strains, two flu strains that are more common in younger populations.
“We are encouraged by the safety and tolerability profile, and by the strong immunogenicity results against Influenza A viruses which cause the overwhelming majority of flu-related disease in older adults," Moderna president Dr Stephen Hoge commented.
"While we did not achieve non-inferiority for the Influenza B strains which are more frequent in younger populations, we have already updated the vaccine that we believe could improve immune responses against Influenza B and will seek to quickly confirm those improvements in an upcoming clinical study thanks to the agility of our mRNA platform."
Efficacy results expected from Phase 3 study
Hoge added that the company is now looking forward to the efficacy results from the ongoing pivotal Phase 3 efficacy study being conducted in parallel.
This study, being conducted in Northern Hemisphere countries, has accrued more than 200 PCR-confirmed cases, almost all of whom are influenza A consistent with the burden of disease in older adults, Moderna said.
The company noted that the first per-protocol interim analysis of efficacy is now expected to be reviewed by an independent Data and Safety Monitoring Board (DSMB) before the end of the first quarter.
Based on these results the DSMB will notify Moderna whether the primary efficacy endpoint has been met or whether the study should continue accruing further cases toward the final analysis.
Moderna Inc stock was down 5.4% at US$163.04 in pre-market trading on Friday.
Contact the author at emily.jarvie@proactiveinvestors.com
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