Human Data First
Biochemical and physiological differences between animals and humans pose significant challenges in translating preclinical safety and efficacy studies into clinical outcomes. While animal models continue to be an essential tool in biomedical research and drug discovery, the fact that nearly 96% of all animal-tested compounds fail in clinical trials underscores the need to adopt a more modern approach and add human data at the preclinical stage. Our advanced platform bridges the gap between preclinical testing and human-based clinical trials, saving company resources while potentially increasing the number of drugs that make it to market.
AnaBios’ advanced human tissue-based methods are enabling a modernized approach that integrates animal models with human ex vivo studies. This provides a very powerful strategy that combines the benefit of in vivo measurements (in animals) with the ability to generate human data (ex vivo) to overcome the challenges of cross-species translation.
The Benefits of Human Data in Preclinical Phases:
- Accurate identification of drug targets
- Calibrate the translatability of animal model
- Overcome false positive toxicity signals from animal models
- Resolve discordant results that occur in different model species
- Save resources by limiting GLP toxicology studies to compounds with real potential in humans
- Maximize efficacy and safety of lead compounds using authentic human targets
- Enhance the IND application with validated human data
- Guide dose selection for clinical studies
AnaBios offers a unique opportunity to study gene expression, proteomic and metabolomic profiles in authentic human tissues from healthy or diseased donors, providing great value when searching for new molecular targets or validating pre-selected targets.
Diseased and healthy human tissue samples enable the discovery of compounds with the desired selectivity profile. The high quality of samples procured by AnaBios enables the generation of highly dependable data for assessing the potential efficacy-related effects of a drug candidate or its toxicity risks.
AnaBios’ proprietary technology maximizes safety and efficacy of lead compounds with authentic human targets. By utilizing human cells and tissues, drug properties are improved by maintaining focus on the human target while keeping the desired activity in humans and minimizing misleading information due to species differences.
Clinical Candidate Selection
Regulatory requirements mandate the use of animal models for toxicology studies, which are expensive and time consuming. By strategically leveraging the power of AnaBios’ technology to identify the molecules with the highest potential for suitable efficacy and safety profile in humans, programs can focus on conducting GLP toxicological studies on a few high value compounds. In addition, the generation of human data at the preclinical stage offers the opportunity to make informed decisions with regards to dosing in clinical studies.
AnaBios’ proprietary technology supports mechanistic studies to de-convolute clinical stage toxicity signals. Elucidating the mechanism of action enables the generation of risk mitigation strategies and allows continued development of the drug. Utilization of human cells and tissues provides a superior approach for clinical stage de-risking.