Human PREdict

Despite extensive preclinical in vitro and animal screening tests, >90% of new drugs still fail in clinical trials. Key issues of lack of efficacy (40-60%) and toxicity (30%) in humans are still not sufficiently predicted in cell culture and non-human in vivo tests (animal models are just 50% accurate on average). The issue wastes years of development time and billions of Euros on unsuccessful therapies. The EMA and FDA recognise this problem and welcome novel technologies as alternatives to animal testing with more accurate predictive value to humans. However, a solution that meets industry needs does not currently exist. To meet this need, researchers and the pharmaceutical industry need an in vitro human tissue analogue that is (i) 3D, (ii) compositionally identical to human tissue, and (iii) has accurate physico-mechanical properties (stiffness, elasticity) that can be tuned to represent different tissue environments. Inability to mimic these environments leads to cellular behaviour not seen in vivo. Metatissue has the only biomatrix technology that meets all key user requirements. Derived from sustainable human platelet lysates, our technology ‘hPLMA’ can be used across 3D culture, bioink and organ-on-chip models. hPLMA most closely represents human tissue, through a 3D, human-derived, xeno-free biomatrix that can be tailored to represent any tissue physiology. It eliminates potential immune reactions to animal proteins and residual DNA/disease-causing prions and viruses. Researchers could significantly reduce use of animals in research and save billions in drug development costs with our practical and scalable solution. Our technology is patent protected, funded to TRL6 with the support of the ERC and Horizon 2020. This is a multibillion Euro market, with hPLMA revenues of €32 million forecast within 5 years of market entry. With EIC support we can complete our scale-up and extended user trials, and achieve full market readiness.