" class="no-js "lang="en-US"> Jnana Therapeutics Cleared by FDA for Phenylketonuria Treatment
Friday, March 31, 2023

Jnana Therapeutics Announces FDA Clearance of IND Application for JNT-517 for the Treatment of Phenylketonuria

Jnana Therapeutics, a biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, has announced that it has received clearance from the US Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for the clinical study of JNT-517 for the treatment of phenylketonuria (PKU).

Jnana’s ongoing Phase 1 program of JNT-517 was initiated in Australia in the fourth quarter of 2022 in healthy volunteers (the Phase 1a sub-study). Following Phase 1a, the program will expand to include clinical sites in the U.S., and the Phase 1b sub-study will evaluate JNT-517 in individuals with PKU, with the potential to demonstrate clinical proof of concept supporting a subsequent registrational program.

“Clearance of our IND for JNT-517 by the FDA, Jnana’s first IND filing, marks an exciting next step for Jnana and we believe for individuals with PKU who have limited treatment options,” said Joanne Kotz, Ph.D., co-founder and CEO of Jnana Therapeutics. “We are very excited to advance our Phase 1 program and look forward to working with investigators, advocacy groups, and individuals living with PKU.”

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