Moderna is looking to add an additional cohort to a late-stage study evaluating its norovirus vaccine hopeful, mRNA-1403, after the jab failed to demonstrate early signs of success.
Announced alongside the company’s Q2 earnings, Moderna noted that mRNA-1403 did not meet the statistical criteria for early success in an interim analysis of the Phase III Nova 301 trial (NCT06592794), leading the company to investigate other potential avenues in terms of vaccine recipients for the shot’s development.
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According to Moderna, the trial will remain ongoing and blinded while the Massachusetts-based pharma company progresses on enrolling the new cohort. As per ClinicalTrials.gov, the observer-blinded, placebo-controlled Nova 301 study, to date, has enrolled 37,864 adults across 283 global locations.
In the Q&A portion of Moderna’s Q2 earnings call, the company’s chief development officer, David Berman, noted that the fourth cohort Moderna plans to enrol in this study will strengthen the power of the trial’s statistical analysis.
When approached by Clinical Trials Arena, Moderna declined to provide further information on its future plans for the Nova 301 study.
Addressing unmet needs in norovirus
Norovirus is a highly contagious and common infectious disease that impacts the stomach and often causes affected individuals to experience vomiting, diarrhoea and a fever. While symptoms of the disease typically last between one and three days and many make a full recovery, researchers estimate that norovirus is responsible for around 200,000 deaths globally each year.
Moderna developed mRNA-1403 in a bid to get a preventative option for norovirus to market. The company designed the vaccine to protect recipients against three globally prevalent strains of norovirus, and it incorporates messenger RNAs (mRNAs) encoding a major structural protein, dubbed VP1. Many viruses express this protein on their outer shell.
Despite the commonality and potential severity of norovirus, there are currently no approved vaccines to prevent the disease. While Moderna currently holds the most advanced clinical development programme for a norovirus jab, fellow vaccine developer Vaxart is also progressing its bivalent candidate through the clinical pipeline.
Unlike mRNA-1403, which is administered via an intramuscular injection, Vaxart’s solution is given orally. Recently, the company debuted data from the Phase IIb Challenge study (NCT05212168), in which Vaxart’s candidate met five of its six primary endpoints.
