Jnana Therapeutics Announces Dosing of First Participant in Phase 1b Clinical Trial of JNT-517 in Individuals with PKU
JNT-517 is a Potential First-in-Class Oral Treatment for PKU; Phase 1b Study Follows Positive Clinical Proof of Mechanism Data in Healthy Individuals
Upcoming Oral Presentation of Phase 1a Study Results at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023
Excerpt from the Press Release:
BOSTON, Aug. 09, 2023 (GLOBE NEWSWIRE) — Jnana Therapeutics, a clinical-stage biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced that the first participant has been dosed in its Phase 1b clinical trial of JNT-517 in individuals with phenylketonuria (PKU). JNT-517 is a small molecule inhibitor of the phenylalanine (Phe) transporter SLC6A19 and is in development as a potential first-in-class oral treatment for PKU.
“Dosing the first individual with PKU with JNT-517 is an important next step toward potentially improving the quality of life and health for people living with PKU,” said George Vratsanos, M.D., CMO and Head of R&D for Jnana Therapeutics. “I’m thrilled to have joined Jnana at this critical point in the PKU program’s progression.”
The Phase 1b study is a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, pharmacokinetics, and effect on plasma and urinary Phe of JNT-517 over a four-week period in individuals with PKU. The study expects to enroll 28 participants aged 18 to 65 diagnosed with PKU at clinical sites in the United States and Australia. For more information about the study, please see clinicaltrials.gov (NCT05781399).
“New treatments are needed that address all genotypes, especially the classical, or severe, form of PKU. JNT-517 offers a promising new approach, with the potential to reduce elevated plasma Phe levels across all levels of disease severity, and has demonstrated positive results with compelling proof of mechanism in a Phase 1a study,” said John Throup, Ph.D., Senior Vice President & Head of Development at Jnana Therapeutics.
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