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Fast Track Designation for Denali Diagnostics

March 22, 2021 – When Ryan Watts, BS’00, steps into the classroom at the University of Utah to discuss with students the opportunities they have in bio-tech, the founder/CEO of San Francisco-based Denali Therapeutics speaks from deep experience.

His knowledge of the subject is unfolding in real-time, including earlier this month when Denali announced that Fast Track Designation has been granted by the U.S. FDA to his company’s ETV:IDS (DNL310) for the treatment of patients with Hunter Syndrome (MPS II).

DNL310, Denali’s lead investigational brain-penetrant enzyme replacement therapy, is under evaluation in a Phase 1/2 study in patients with Hunter Syndrome as a potential treatment for both central nervous system (CNS) and peripheral manifestations of the disease.

“Hunter syndrome is a devastating disease for which current approved treatments fail to effectively cross the blood-brain barrier and therefore do not address CNS symptoms,” said Carole Ho, M.D., Denali’s Chief Medical Officer (pictured right). “Using Denali’s Transport Vehicle technology, we have designed DNL310 to treat both body and brain in Hunter syndrome after intravenous administration. Receiving Fast Track designation is an important milestone in the DNL310 development program, and we look forward to our continued collaboration with the FDA to bring safe and effective treatments to patients with Hunter syndrome.”

Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Denali expects that Fast Track designation may allow for early and frequent communication with the FDA regarding the development of DNL310 for the treatment of Hunter syndrome. This designation also enables rolling review, and potentially priority review, of the marketing application. Read the press release here.

An SBS Distinguished Alumnus Awardee, Dr. Watts teaches currently teaches a class on bio-tech start-ups.