Vivosim Labs Notes FDA's Direct Final Rule Clarifying That Non-Animal Methods Can Be Used Where Appropriate For Testing Safety Of Drugs And Biological Products For Human Use

The FDA’s new rule replaces the term "animal tests" with "nonclinical tests" across its regulatory framework, formally opening pathways for NAMs, including human cell-based tests such as those offered by VivoSim.

VivoSim's liver tissue models are capable of flagging drug candidates likely to cause liver toxicity, side effects like diarrhea, and other issues. Liver toxicity is the leading cause of drug failures and market withdrawals. The company has the ability to meaningfully de-risk a client company’s set of compounds and rule out likely failures prior to its selection of a drug to enter clinical testing.

Drug-induced liver injury (DILI) and gastrointestinal (GI) toxicity remain leading causes of drug candidate attrition. VivoSim's findings demonstrate how its long-duration, primary human cell-based models can help identify and differentiate these risks earlier in development, successfully ranking clinical safety risks for clients’ drug candidates.