Kynexis raises €40 million to advance KYN-5356, an investigational KAT-II inhibitor in Phase 2 development for cognitive impairment associated with schizophrenia.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Kynexis has raised €40 million in a Series A extension to advance KYN-5356, an investigational KAT-II inhibitor being evaluated for cognitive impairment associated with schizophrenia (CIAS), and prepare for potential registrational development. The company has completed enrollment in its Phase 2 proof-of-concept trial and expects topline results by the end of 2026.
KYN-5356 Targets the Kynurenine Pathway
KYN-5356 is an oral small-molecule inhibitor of kynurenine aminotransferase II (KAT-II), the primary enzyme responsible for producing kynurenic acid (KYNA) in the brain.
Elevated KYNA is believed to disrupt signaling through NMDA and α7 nicotinic acetylcholine receptors, which are involved in learning, memory, and executive function. KAT-II inhibition lowers KYNA production and could help restore signaling involved in cognitive function.
Cognitive impairment remains a major unmet need in schizophrenia. Although antipsychotic treatments can control core psychotic symptoms, cognitive deficits may persist and substantially affect daily functioning and quality of life.
Phase 2 Trial Completes Enrollment
The randomized, double-blind, placebo-controlled Phase 2 trial (NCT07191483) enrolled approximately 150 adults with CIAS across 13 clinical sites in the United States.
The 28-day study is evaluating KYN-5356 as an adjunctive treatment, with efficacy, safety, pharmacokinetic, and pharmacodynamic assessments. Kynexis has completed enrollment and expects to report topline results by the end of 2026.
The Phase 2 program follows a Phase 1 study in healthy volunteers. In that study, KYN-5356 demonstrated favorable safety and tolerability, central nervous system penetration, and dose-dependent reductions in cerebrospinal fluid KYNA. These findings provided early clinical evidence supporting target engagement and the proposed mechanism of action.
Series A Financing Supports Clinical Development
The €40 million financing extension brings Kynexis’ total Series A funding to €97 million ($110 million). Novartis Venture Fund led the financing, with participation from existing investors Forbion, Ysios Capital, and Sunstone Life Science Ventures.
The funding will support completion of the Phase 2 program and preparations for registrational clinical development in CIAS. Kynexis also plans to advance KYN-5356 into additional cognitive disorders, including Alzheimer’s disease.
As part of the financing, Novartis Venture Fund’s Marianne Uteng joined the Kynexis Board of Directors, while Mathias Frederiksen joined as a Board Observer. The company also appointed Neil Swami as Chief Business Officer and added John McDonald, former Head of M&A at Novo and current Operating Partner of Business Development and M&A at Forbion, as an advisor.
Next Clinical Milestone
Kynexis CEO Kees Been said the financing will support continued clinical development of KYN-5356 and preparation for registrational studies in CIAS. The company also plans to evaluate KAT-II inhibition across additional neurological and neurodegenerative disorders.
The Phase 2 topline readout expected by the end of 2026 will provide the next clinical test of KAT-II inhibition in CIAS. If the efficacy and safety findings support further development, the results could inform the design and scope of subsequent registrational studies.
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About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.