Cognision Announces Partnership with Kynexis to Utilize its COGNISION® System in a Phase 2 Trial of KYN-5356 in Subjects with Schizophrenia

LOUISVILLE, Ky., Nov. 14, 2025 /PRNewswire/ -- Cognision, provider of advanced neurobiomarker technology, announces its partnership with Kynexis to utilize the COGNISION^® System in Kynexis' Phase 2 clinical trial of KYN-5356 in subjects with schizophrenia.

KYN‑5356 is designed to inhibit KAT‑II, an enzyme central to the kynurenine pathway implicated in cognitive impairment associated with schizophrenia (CIAS)—a debilitating symptom for which no approved treatments currently exist. The ongoing Phase 2 study is designed to establish proof of clinical concept for KYN-5356 by demonstrating its efficacy in improving cognitive performance.

Kynexis chose to partner with Cognision and utilize the COGNISION^® System to precisely measure drug-induced changes in brain function. The measurements that are obtained during EEG and ERP testing sessions, conducted after the administration of either KYN-5356 or a placebo, have the ability to link therapeutic effects with objective biomarkers related to the mechanism of action and disease biology.

"We are pleased to collaborate with Kynexis on this important clinical study," said Marco Cecchi, CSO of Cognision. "Our EEG and ERP platform enables objective measurement of neural activity and cognitive processing in real time. By assessing the effects of KYN-5356 on brain function in individuals with schizophrenia, we aim to provide early neurophysiological markers of drug response that may inform the development of more targeted and effective therapies for this population."

"By integrating Cognision's EEG/ERP platform into our KYN-5356 trial, we're able to enrich our primary cognitive assessments with complementary, objective data on brain function," said Dr. Jens Wendland, Chief Medical Officer at Kynexis. "This collaboration allows us to better understand the relationship between cognitive outcomes and underlying neurophysiology, strengthening our approach to developing KYN-5356 in CIAS."

The COGNISION System is used in the ERP Biomarker Qualification Consortium (erpbiomarkers.org), a precompetitive consortium involving ten pharmaceutical companies. The objective of the consortium is to optimize and standardize EEG/ERP techniques for widespread use in clinical trials of drugs targeting brain function. Kynexis is leveraging insights from this consortium in its trial of KYN-5356. Specific measures used in the trial were previously validated for use with schizophrenic subjects in a consortium sponsored trial, https://clinicaltrials.gov/study/NCT04025502, and were then published in a peer-reviewed journal Cecchi, et al, 2023.

Further details about the Phase 2 trial of KYN-5356 are available at www.clinicaltrials.gov (Identifier: NCT07191483).

About Cognision

Cognision is the leading provider of advanced EEG/ERP/PSG/Cognition biomarker technologies and software used in pharma-sponsored clinical trials. With the COGNISION^® System, pharma companies can gain near-realtime insights into the neural effects of brain-targeting compounds. The COGNISION^® System is also used by clinicians to evaluate patients suffering from Alzheimer's disease, concussion, and other brain disorders. Learn more at cognision.com and follow us on LinkedIn.

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 kynexistx.com and follow us on LinkedIn.

For media inquiries or further information, please contact:

Nathan Alvarado
502-561-7005
Director of Business Development
nalvarado@cognision.com
www.cognision.com
www.erpbiomarkers.org

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SOURCE Cognision