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SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company”) announced that it has emerged from stealth mode to dramatically impact drug discovery and development.
VivoSim will offer liver and intestinal toxicology insights using its premier new approach methodologies (NAM) models, following the announcement of the FDA to phase out animal testing requirements in favor of these non-animal NAM methods. The FDA’s push to phase out animal models, announced on April 10, is expected to provide a powerful accelerant to VivoSim’s market adoption, disrupting a >$10B animal testing market with models that are more predictive and ethically sound.
As FDA Commissioner Martin A. Makary M.D., M.P.H. said in FDA’s announcement: “This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use. By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices.”
VivoSim’s models include physical organoid wet lab models of liver and intestine made using cells from human donors. VivoSim is developing what it believes will be industry-best in silico predictions of liver tox, intestinal tox, and permeability. Artificial intelligence (AI) models in VivoSim’s NAMkind™ services suite will be trained on an extensive set of proprietary, real world data from organoid models made from human donor cells, giving much richer and more extensive information than is possible with data from human clinical trials.
VivoSim has the capability to help transform the way drug development is done. By substantially reducing failures in clinical trials, the company believes it can help reduce the cost of development per approved drug by 50% across the industry.
In development testing, VivoSim’s NAMkind liver model produced liver toxicology results across a wide set of positive and negative control compounds that resulted in an industry best correlation rate with known clinical failures. As a result of the inability to fully predict liver toxicity, a number of drugs today still fail clinical trials at late stages or are pulled from the market after launch due to unforeseen liver toxicity. VivoSim believes it will cut the incidence of such events by 50% or more.
VivoSim’s NAMkind intestine models can deliver readouts that are today not available to industry scientists selecting from many candidate drug molecules. As a result of the lack of such tools, a cancer patient might suffer nausea, vomiting, or intestinal problems, or a patient’s needed chemotherapy dose might be lower than it could be due to such conditions. VivoSim aims to provide transformative solutions for these challenges.