Kinoxis Secures $2.5M CUREator+ Grant to Support CARES-X, A Phase 2a Australia-Based Clinical Study for KNX100 in Treating Agitation Associated with Dementia
MELBOURNE, AUSTRALIA, 23 December 2024 – Kinoxis Therapeutics, an Australian clinical stage biotechnology company developing novel therapies for behavioural and psychological symptoms in neuropsychiatric disorders, is pleased to announce that it has been awarded a $2.5 million grant from the CUREator+ program.
Globally, 55 million people live with dementia, with agitation and aggression affecting 76% of dementia patients, this presents a significant challenge for caregivers and healthcare systems.
Currently, the only FDA approved drug that targets dementia associated agitation due to Alzheimer’s disease, carries an FDA-issued black box warning that it may increase the risk of death in elderly patients with dementia-related psychosis.
The CUREator+ grant will support Kinoxis’ CARES-X Study, a Phase 2a clinical study that has recently commenced patient recruitment and will be conducted across 8 Australian sites. This study will examine the safety, tolerability, and efficacy of Kinoxis’ lead candidate, KNX100, in treating subjects with agitation associated with dementia.
“We are thrilled to receive this prestigious grant from the CUREator+ program,” said Hugh Alsop, CEO of Kinoxis Therapeutics. “This funding will enable us to expedite the development of KNX100, bringing us closer to providing a much-needed treatment option for patients suffering from agitation and aggression in dementia. We are committed to making a meaningful difference in the lives of these patients and their families.”
The clinical study design for KNX100 has been designed with input from global and local leaders in dementia research. Prof. Jeffrey Cummings and A/Prof. Michael Woodward bring extensive experience in pioneering the development and approval of treatments that have shaped current clinical practices.
A carer focus group, comprising of eight advisors who have firsthand experience caring for loved ones with dementia, ensures the study addresses the real-world challenges experienced by both patients and caregivers.
The CARES-X study aims to evaluate how taking KNX100, twice a day for four weeks, affects agitation symptoms in dementia patients. The study will primarily measure changes in these symptoms using a specific scale called the Cohen-Mansfield Agitation Inventory. Researchers will also look at how KNX100 influences other factors like neuropsychiatric symptoms, overall disease severity, caregiver stress, and sleep patterns.
CUREator+ is a national incubator designed to accelerate research translation and commercialisation of early-stage Australian medical research and innovations. A partnership between Brandon BioCatalyst and ANDHealth CUREator +, the initiative is supported by the Federal Government’s Medical Research Future Fund (MRFF).
Kinoxis was selected by the CUREator + Investment Review Committee as part of a competitive selection process designed to select projects with commercial potential. The program’s selection criteria include an evaluation of clinical and commercial differentiation, intellectual property (IP) position, market opportunity, and the project’s maturity and development stage.
Seeking out novel and outstanding projects that address significant unmet medical needs and demonstrate clear differentiation from existing standard care, CUREator+ serves as an important apparatus for research translation, bridging the funding gap for researchers and innovators at an early-stage.
Learn more about the CARES-X trial here
Read the full release here
Investor Contact:
Hugh Alsop – CEO Kinoxis Therapeutics Pty Ltd
hugh.alsop@kinoxistherapeutics.com
Media Contact:
Evelyn Yang
evelyn.yang@irdepartment.com.au
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About Kinoxis Therapeutics
Kinoxis Therapeutics Pty Ltd (Kinoxis) is a private, Australian-based, clinical-stage biotechnology company developing first-in-class therapeutics to address the escalating demand for safe and effective treatments for behavioural and psychological symptoms in neuropsychiatric disorders.
Kinoxis’ lead candidate, KNX100, is being developed for the treatment of behavioural and psychological symptoms in neuropsychiatric disorders, including agitation and aggression in dementia, and several substance use disorders. KNX100 has a novel mechanism of action, interacting with disease relevant pharmacological, molecular, and neural targets, to modify the dysregulated brain systems linked with specific behavioural and psychological symptoms in neuropsychiatric disorders.
The compound has an extensive pre-clinical data package consisting of multiple crossspecies animal efficacy models conducted across several independent research organisations. Kinoxis has completed a Phase 1 study conducted under a US IND and have demonstrated KNX100 to be safe and tolerable in healthy volunteers.
Currently, KNX100 is being investigated in the CARES-X Phase 2 clinical trial, a multi-site study in Australia focused exploring its safety, tolerability, and efficacy as a treatment for agitation in dementia. Kinoxis is also advancing clinical programs targeting stimulant, opioid, and alcohol use disorders. Notably, the alcohol use disorder program is being developed in collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA), while the opioid use disorder program has received significant funding from the US National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA).
In addition, to the KNX100 program, Kinoxis have a strategic partnership and licensing agreement with Boehringer Ingelheim to develop first-in-class oxytocin receptor targeting precision psychiatry treatments to improve the quality of life of people living with neuropsychiatric disorders.
Learn more at www.kinoxistherapeutics.com
About CUREator
CUREator is a national biotechnology incubator by Brandon BioCatalyst that supports Australian biomedical research and innovation development. Funded by the Medical Research Future Fund and Australia’s national science agency, CSIRO, CUREator provides grant funding programs for opportunities spanning from discovery research to clinical development.
Funding is provided like an investor with clear milestone-driven tranches to achieve key value-adding and de-risking development milestones. CUREator works closely with project teams to guide them through the early development phases, offering scientific and commercial expertise and networks to support projects meeting key outcomes.
https://brandonbiocatalyst.com/cureator/
About ANDHealth
ANDHealth is Australia’s only organisation specialising in commercialising evidencebased digital health technologies. We work with Australian digital health companies to commercialise and scale their clinical-grade technologies through the entire commercialisation pathway, from idea to exit.
ANDHealth’s investment readiness program suite and non-dilutive investment programs prepare companies for institutional investment and global enterprise customers and have been proven to positively impact both the number and maturity of companies in the Australian evidence-based digital and connected health sector. Since 2018, ANDHealth has supported over 900 high-growth-potential digital health companies across Australia and delivered over 2,400 hours of direct programming to over 1,680 participants.
About Brandon
BioCatalyst and Brandon Capital Brandon Capital is Australasia’s leading life science venture capital firm, with a solid global presence supported by key partnerships and team members across the US and UK. Brandon Capital supports life science companies from early-stage seed investment to expansion capital from proof-of-concept to commercialisation. Managed by Brandon Capital, Brandon BioCatalyst is a unique collaboration of over 50 leading medical research institutes, investors, and government united by a single purpose: progressing the next generation of medical therapies and technology that improve health and save lives.