|“Lilly believes a significant benefit of TransForm’s technology is in early lead optimization. The technology also has the potential to greatly speed up the time to identify an optimal form/formulation in those platforms where existing Lilly efforts have been slowed or unsuccessful.”|
|Andrew M. Dahlem, PhD|
|Vice President, Lilly Research Laboratories|
For poorly soluble compounds, extensive formulation work may be needed in order to achieve sufficient exposure for initial animal dosing, for toxicity studies and ultimately to deliver the desired dose to humans. As part of our collaboration with Eli Lilly and Company, TransForm has designed technologies to rapidly identify “customized” formulations for early animal dosing, using pharmaceutically acceptable vehicles at acceptable levels, with as little as 150mg of material. Our formulation platforms also enable us to maximize aqueous content, where desirable.
When our “customized” formulations were compared by Lilly with their “standard” formulations, our formulations achieved as much as 30X better bioavailability over that of the standard formulations. As part of the same series of high-throughput formulation experiments, moreover, TransForm scientists are able to identify IV formulations that permit our partner to determine absolute bioavailability. Finally, because our formulations for animal studies are designed with acceptable excipients and with toxicity limits in mind, they can provide our partners with a significant head start on identifying a suitable formulation for initial human dosing.