VivoSim Labs Highlights FDA Pathway For Human-Based Safety Testing;Stock Up
(RTTNews) - VivoSim Labs, Inc. (VIVS), a provider of next-generation New Approach Methodologies (NAM) 3D human cellular models for preclinical safety, highlighted the FDA's updated regulations allowing greater use of non-animal testing methods for drugs and biological products intended for human use.
The FDA's final rule replaces the term "animal tests" with "nonclinical tests" across its regulatory framework, opening pathways for appropriate non-animal methods, including human cell-based testing.
VivoSim said its human-relevant liver tissue models can help identify drug candidates that may cause liver toxicity, gastrointestinal side effects and other safety issues during preclinical development.
Drug-induced liver injury and gastrointestinal toxicity remain significant causes of drug candidate attrition, and VivoSim said its long-duration, primary human cell-based models can help identify and differentiate these risks earlier in development.
The company's models are designed to provide insights that can help pharmaceutical and biotechnology companies evaluate safety risks and eliminate potentially problematic drug candidates before clinical testing.
VivoSim said early identification of risky molecules could help reduce development costs by allowing companies to move forward with candidates that demonstrate more favorable safety profiles.
The company expects the FDA's updated regulatory framework to support broader adoption of human tissue models and other non-animal New Approach Methodologies in drug development.
VivoSim's NAMkind Models include 3D human tissue models of the liver and intestine designed to provide toxicology insights for drug and drug candidate testing.
VivoSim Labs provides pharmaceutical and biotechnology services focused on testing drugs and drug candidates using 3D human tissue models for preclinical safety assessment.
VIVS shares Tuesday's closed at $0.20, down 2.18%. In the premarket, stock is up 2.03% at $0.20.
