Kynexis Announces Initiation of First-in-Human Phase 1 Study of KYN-5356, a Potential Treatment for Cognitive Impairment Associated with Schizophrenia

KYN-5356is an innovative, first-in-class small molecule that targets KAT-II, a key enzyme in the kynurenine pathway

Topline results are expected in the second half of 2024

Naarden, The Netherlands – January 4, 2024 – Kynexis, a biotechnology company focused on precision therapeutics by leveraging biomarkers and human genetics for brain diseases, announced today that the first healthy volunteers have been dosed in its first-in-human phase 1 study of KYN-5356. KYN-5356, a clinical-stage small molecule targeting a key enzyme in the kynurenine pathway known as KAT-II, is being developed for cognitive impairment associated with schizophrenia(CIAS). Kynexis expects to report preliminary data from the phase 1 study later this year.

“Cognitive impairment is a major cause of disability for most people affected with schizophrenia, and there are currently no approved treatments for CIAS,” said Kees Been, Chief Executive Officer at Kynexis. “KYN-5356 is potent, highly selective, and enters the CNS, solving the challenges of previous attempts at KAT-II inhibition. We are committed to advancing this potential treatment to restore brain function and enable a better life for people with schizophrenia, and we look forward to reporting initial data from this study later this year.”

Kynexis’ phase 1 clinical trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of KYN-5356 in adult, healthy subjects. For more information on this clinical trial, visit

About Kynexis

Kynexis is advancing precision therapeutics for brain diseases by taking a biomarker-based approach to advance a potential treatment for cognitive impairment associated with schizophrenia (CIAS). By harnessing large data to identify and stratify patients based on the underlying causal human biology of the disease, Kynexis is targeting KAT-II, a key enzyme in the kynurenine pathway. The company’s lead candidate, KYN-5356, is a first-in-class small molecule that is potent and highly selective for KAT-II. The Company has a subsidiary in the United States, which is based in Cambridge, Mass. (Kynexis Therapeutics Inc.). Learn more at and follow us on LinkedIn and X/Twitter.  

Media Contact:
Adam Silverstein
Scient PR

By clicking “Accept”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts.