Sequoia Pharmaceuticals has submitted an investigational new drug application with the FDA to begin human clinical trials with SPI-452, a novel pharmacokinetic enhancer.
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SPI-452 is said to be designed to improve the exposure of co-administered HIV medications thereby providing more efficacious, less toxic and more user-friendly drug regimens.
Sequoia’s first IND was submitted for its novel HIV protease inhibitor, SPI-256, in February 2007, and ongoing Phase I clinical trials continue to yield favorable results.
Steven Skolsky, CEO of Sequoia, said: “To have discovered and developed two drug candidates within five years of founding and to submit two IND’s in one year is an outstanding demonstration of the commitment and capability of the entire organization.”
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