Transporter assay services firm Optivia Biotechnologies won a $1.85 million Phase II SBIR grant from the National Institute of General Medical Sciences to fund development of a broad set of assays and databases for use in identifying clinically significant drug- drug interactions that involve membrane transporters.
The overall program will exploit Optivia’s Opti-Expression™ platform to develop over 50 assays for key human and rat transporters. The firm says that while many of these were identified by FDA’s 2006 draft guidance outlining a framework for evaluating transporter-mediated drug-drug interactions, suitable experimental assays for most have yet to be developed.
“This research will lay the foundation for Optivia and our collaborators to build the most comprehensive transporter-biology platform available including standardized in vitro assays, in silico models, and an extensive knowledge base to better understand, predict, and alleviate transporter-mediated adverse drug reactions,” comments Yong Huang, Ph.D., president and CEO at Optivia.
The grant includes $367,000 to support research at the University of California, San Francisco (UCSF), focused on profiling 2,000 prescription drugs against key transporters in the liver and kidneys. “This will be the largest and most comprehensive study to date on the interaction between prescription drugs and membrane transporters,” comments Kathleen Giacomini, Ph.D., professor and co-chair of the UCSF department of bioengineering and therapeutic sciences, who is co-principal investigator for the grant. “Many transporters are known to influence drug levels, but very little is currently known about transporter-related drug interactions. This grant will enable us to break new ground in transporter-biology research and ultimately help identify which medications could cause transporter-related drug interactions and lead to adverse reactions when taken with other drugs.”
Optivia’s Opti-Expression technology has been designed to enable the consistent expression of various transporter proteins in polarized mammalian cell monolayers. The firm claims that in comparison with the use of stably transfected cell lines, its transient expression approach is quicker, more cost-effective, and scalable and provides flexibility in transporter assay development and set up.
Award of the Phase II SBIR grant comes just a couple of months after the firm signed a deal with FDA to assess the effect of dietary supplements on key drug transporters. The collaboration will initially focus on the seven transporters cited by the International Transporter Consortium and FDA as the most clinically relevant in terms of transporter-related drug-drug interactions.