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Shares of vaccine-developer HilleVax Inc HLVX are down on Monday on a session volume of over 7 million as per data from Benzinga Pro . Monday, the company released topline data results from the NEST-IN1 Phase 2b randomized, double-blind, placebo-controlled trial of the efficacy, safety, and immunogenicity of HIL-214 in infants approximately five months of age at the time of initial vaccination . HIL-214 is the company’s investigational virus-like particle (VLP) based vaccine to prevent moderate-to-severe norovirus-related acute gastroenteritis.
Norovirus, also called the “winter vomiting bug,” is a stomach bug that causes vomiting and diarrhea. 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 a vaccine efficacy of 5%. 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. No clinical benefit was observed across secondary endpoints.
HIL-214 exhibited a safety and immunogenicity profile consistent with what was observed in the prespecified analysis of the first 200 subjects in NEST-IN1 and in previously reported studies. “We are disappointed that the NEST-IN1 study did not meet its primary efficacy endpoint,” said Rob Hershberg, Chairman and Chief Executive Officer of HilleVax. “While HIL-214 previously showed clinical benefit in adults, NEST-.
