In July 2024, HilleVax announced top-line data from its NEST-IN1 Phase 2b clinical trial for HIL-214.00, its lead infant norovirus vaccine candidate. The trial did not meet its primary endpoint of efficacy against moderate or severe acute gastroenteritis (AGE) events caused by specific norovirus genotypes in infants. No clinical benefit was observed across secondary endpoints, despite a consistent safety and immunogenicity profile.
The lack of efficacy led to the immediate discontinuation of further development of HIL-214.00 in infants. This outcome prompted a significant strategic re-evaluation for the clinical-stage biopharmaceutical company. The decision was made to cease all further development of the candidate in this indication.
The discontinuation of HIL-214.00, which was a primary focus for HilleVax, represents a major setback for the company's vaccine development efforts. This event necessitated a re-assessment of the company's pipeline and future strategic direction.
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