Australian biotech Kinoxis Therapeutics has been awarded a $2.5 million grant via the CUREator+ program to support its Phase 2a CARES-X clinical trial. The trial will evaluate the safety, tolerability, and efficacy of Kinoxis’ lead candidate, KNX100, in treating agitation associated with dementia.
The CARES-X study, which has commenced patient recruitment across eight Australian sites, aims to provide an alternative to existing treatments that are limited and carry significant risks. The trial’s primary endpoint is the improvement of agitation symptoms in individuals with dementia over a four-week treatment period, measured using the Cohen-Mansfield Agitation Inventory.
The Need for New Treatments
Globally, 55 million people live with dementia, and agitation affects over 76% of these individuals. Current treatment options, including the sole FDA-approved drug for Alzheimer’s-related agitation, carry a black box warning due to an increased risk of death in elderly patients with dementia-related psychosis. This highlights the urgent need for safer and more effective treatments.
KNX100: A Novel Approach
KNX100 represents a novel approach, targeting specific brain systems linked to behavioral and psychological symptoms of dementia. The CARES-X trial has been designed with input from global dementia experts, including Professor Jeffrey Cummings and Associate Professor Michael Woodward. A dedicated carer focus group also ensures the trial addresses real-world challenges faced by caregivers and families.
According to Hugh Alsop, CEO of Kinoxis Therapeutics, “This funding accelerates the development of KNX100, bringing us closer to addressing the critical unmet need for safe and effective treatments for agitation and aggression in dementia.”
CUREator+ Program
The CUREator+ program, funded by the Federal Government’s Medical Research Future Fund, aims to accelerate the translation of Australian medical research into commercial outcomes. Kinoxis was selected for the grant based on its innovative approach, market potential, and the maturity of its development program.
Beyond Dementia
In addition to its dementia research, Kinoxis is advancing KNX100 for other neuropsychiatric disorders, including substance use disorders, in collaboration with global partners.
