Kynexis, a clinical-stage biotechnology company focused on precision therapeutics for brain diseases, announced that the first patient has been dosed in its Phase 2 clinical trial evaluating KYN-5356, a first-in-class small molecule inhibitor of KAT-II, for the treatment of cognitive impairment associated with schizophrenia (CIAS). As the most advanced clinical candidate in development for CIAS, the trial is designed to establish proof of clinical concept for KYN-5356 by demonstrating its efficacy in improving cognitive performance.

“Advancing KYN-5356 into Phase 2 is a critical milestone in our mission to address cognitive impairment associated with schizophrenia, which is one of the most debilitating and overlooked aspects of the disease,” said Kees Been, Chief Executive Officer of Kynexis. “Because schizophrenia often emerges early in life, these cognitive challenges can impact nearly every facet of a person’s daily living for decades. With no approved treatments for CIAS and existing therapies failing to address these deficits, the need is profound. With a strong scientific foundation, encouraging early clinical data, and a precision approach that targets the underlying biology, we believe KYN-5356 has the potential to enable a better life for people living with schizophrenia.”

Dr. David Walling, Chief Clinical Officer at CenExel and Lead Investigator of the Phase 2 trial, added, “This Phase 2 trial is designed to rigorously evaluate the potential of KYN-5356 to improve cognitive function in people with schizophrenia. By combining standardized cognitive performance measures with pharmacokinetic and pharmacodynamic analyses to link clinical benefits with underlying biological effects, this study will generate the data needed to bring forward a therapy that could transform care for people living with CIAS.”

The Phase 2 trial builds on positive results from Kynexis’s first-in-human Phase 1 trial, in which KYN-5356 demonstrated an excellent safety and tolerability profile, adequate CNS penetration, dose-dependent reductions in kynurenic acid in the cerebrospinal fluid, and exploratory evidence of cognitive benefit in healthy volunteers. The randomized, double-blind, placebo-controlled Phase 2 trial will enroll approximately 150 adults with schizophrenia across 13 clinical sites in the United States. Over a 28-day treatment period, the study will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of KYN-5356 as an adjunctive treatment for CIAS.