HilleVax sinks as norovirus jab fails

9 July 2024

Boston, USA-based clinical-stage biopharma company HilleVax (Nasdaq: HLVX) saw its shares plummet more than 88% to $1.64 by lose of trading on Monday as it pulled the plug on its lead vaccine candidate in infants.

HilleVax announced top-line data results from NEST-IN1. NEST-IN1 is a Phase IIb, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of HIL-214 in infants of around five months of age at the time of initial vaccination at sites in the USA and Latin America.

In the NEST-IN1 study there were 51 primary endpoint events with 25 in the vaccine arm (n=1,425) and 26 in the placebo arm (n=1,399) resulting in vaccine efficacy of 5% (95% confidence interval; -64%, 45%). However, HilleVax noted that the study did not meet its primary endpoint of efficacy against moderate or severe acute gastroenteritis (AGE) events due to GI.1 or GII.4 norovirus genotypes.

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