Clinical-stage Biopharmaceutical Company Announces Negative Results From Clinical Study
Clinical-stage Biopharmaceutical Company Announces Negative Results From Clinical Study
HilleVax, Inc. Announced Disappointing Results from NEST-IN1 Clinical Study.
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On a day that saw its stock plummet by 84%, closing at $2.25, HilleVax, Inc. (Nasdaq: HLVX) announced the topline data results from its NEST-IN1 clinical study. This notable decline followed the announcement that the NEST-IN1 study did not meet its primary or secondary efficacy endpoints, leading the company to discontinue further development of its HIL-214 vaccine in infants.
Background on HilleVax, Inc.
HilleVax, Inc. is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative vaccines. The company's initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate designed to prevent moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. Norovirus is a public health concern globally, contributing to approximately 700 million cases of AGE and 200,000 deaths annually. The economic impact of norovirus is substantial, with direct health system costs exceeding $4 billion and societal costs reaching up to $60 billion each year, disproportionately affecting young children and older adults. The NEST-IN1 study was a Phase 2b, randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy, safety, and immunogenicity of HIL-214 in infants around five months old at the time of initial vaccination. Conducted at sites in the United States and Latin America, the study involved a number of participants: 1,425 in the vaccine arm and 1,399 in the placebo arm.
In the NEST-IN1 study, there were 51 primary endpoint events, with 25 occurring in the vaccine arm and 26 in the placebo arm, resulting in a vaccine efficacy of 5% (95% confidence interval; -64%, 45%). Unfortunately, the study did not meet its primary endpoint of efficacy against moderate or severe AGE events due to GI.1 or GII.4 norovirus genotypes. No clinical benefit was observed across secondary endpoints.
Safety and Immunogenicity Profile
Despite the disappointing efficacy results, HIL-214 demonstrated a safety and immunogenicity profile consistent with previous observations. This consistency was noted both in the prespecified analysis of the first 200 subjects in the NEST-IN1 study and in earlier reported studies. Dr. Rob Hershberg, Chairman and Chief Executive Officer of HilleVax, expressed his disappointment regarding the study's outcome. He stated, "We are disappointed that the NEST-IN1 study did not meet its primary efficacy endpoint." Dr. Hershberg also highlighted that while HIL-214 had previously shown clinical benefits in adults, NEST-IN1 was the first efficacy study conducted in infants for a norovirus vaccine candidate. He suggested that the efficacy in the infant setting might have been impacted by the emergence of multiple new GII.4 strains during the trial.
Dr. Hershberg extended gratitude to the trial investigators, clinical sites, and the HilleVax team for their rigorous efforts in conducting the study. He also expressed deep appreciation to the infants and families who participated in the trial. The NEST-IN1 study followed a Phase 2b study in adults, named NOR-211, which had demonstrated statistically efficacy against moderate or severe AGE due to norovirus. Despite the success in the adult study, the NEST-IN1 study's inability to replicate these results in infants has led to a reassessment of the development strategy for HIL-214.
Following the announcement of the NEST-IN1 study results, HilleVax revealed plans to discontinue further development of HIL-214 in infants. However, the company is exploring the potential for continued development of HIL-214 and another vaccine candidate, HIL-216, in adults. HIL-216 is currently Phase 1 ready, indicating that it is prepared to enter initial human trials to evaluate its safety and immunogenicity.
The announcement of the NEST-IN1 study results had an immediate and severe impact on HilleVax’s stock price, which dropped dramatically by 84% to close at $2.25. This sharp decline reflects the market's reaction to the disappointing clinical trial outcomes and the subsequent decision to halt the development of HIL-214 in infants. Despite the dramatic drop, there remains interest in observing whether the stock will recover, especially given that it had previously been valued at over $20 in the past year. Investors will likely be monitoring HilleVax’s future announcements closely, particularly regarding the development of HIL-214 and HIL-216 in adult populations.
The NEST-IN1 clinical study was a crucial trial for HilleVax, aiming to establish the efficacy of HIL-214 in preventing norovirus-induced AGE in infants. The study's failure to meet its primary and secondary endpoints marks a setback for the company, leading to the discontinuation of HIL-214 development in infants. HilleVax continues to explore opportunities for its vaccine candidates in adult populations, maintaining its commitment to addressing the global burden of norovirus.
Investors and stakeholders will be keeping a close watch on HilleVax’s next steps, as the company pivots its focus towards future developments and potential recovery in its stock performance.
Disclaimer: The information provided in this article is for educational and informational purposes only. It should not be construed as financial or investment advice. Always consult with a qualified professional before making any investment decisions.
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