Partners will develop transporter-based predictive models for early drug development.

Optivia Biotechnologies and the University of California, San Francisco (UCSF) received a $430,000 Phase 1 SBIR grant from the U.S. NIH to develop a platform for studying the effects of transporters on drug disposition by the liver and the interplay of transporters and metabolizing enzymes. The ultimate goal is to provide a transporter-based ADME prediction system for new drug candidates. The collaboration will combine Optivia’s transporter technology platform with the expertise of Leslie Z. Benet, Ph.D. professor and chairman emeritus at UCSF’s department of bioengineering and therapeutic sciences.

Optivia suggests that the ability to integrate analysis of drug transporters into ADME evaluations is likely to become a core regulatory requirement for drug development in the future. “The industry has long observed discrepancies between measuring drug metabolism in existing experimental systems,” comments Yong Huang, Ph.D., Optivia president and CEO. “Transporters likely contribute to the observed discrepancies. Considering transporters when assessing metabolism will result in the generation of better in vitro models.”

“This grant will allow us to build on UCSF’s previous work suggesting that we can predict how drugs behave in the body, specifically in the liver, based on transporter biology,” adds Dr. Benet, who is also a member of the International Transporter Consortium. “We intend to provide a body of systematic data based on the in vitro profiling of a large number of drugs against a panel of key human transporters as the first step toward building transporter-based predictive models for the assessment of ADME and drug-drug interactions.”

Optivia and UCSF initially aim to systematically test 40 marketed drugs against 10 major hepatic transporters, and correlate the in vitro drug transporter interaction data with in vivo data on the disposition of drugs in the liver. The study is designed both to build a better and earlier-stage model for predicting drug activity in humans, and address the interplay between transporters and drug-metabolizing enzymes. “A model that correlates in vitro data to in vivo results would be of incalculable value to the pharmaceutical industry, since it will allow drug developers to make better decisions on the ADME properties of drug candidates prior to performing in vivo studies,” Dr Benet claims. “The unique capabilities of the Optivia platform will allow us to move forward on this critical step in building transporter-based predictive models for ADME.

Optivia offers a range of tailored transporter assay services and products to optimize drug development and the design of safer drugs with improved therapeutic responses. These include substrate transport studies, inhibition studies, and the OptiDDI suite, which has been established as a comprehensive group of in vitro transporter assay services to be used for FDA submissions for the assessment of transporter mediated drug-drug interactions.

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