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Kinoxis Therapeutics has been awarded a grant for a potential of up to $US4.6 million ($6.8 million) under the USA ³Ô¹ÏÍøÕ¾ Institutes of Health Helping to End Addiction Long-Term, or the . The primary target of Kinoxis is the brain oxytocin system, which receives considerable interest for its role in the regulation of social behaviour and inhibitory effects on addictive behaviours.

Out of under the HEAL Initiative, Kinoxis Therapeutics’ grant is the only one received outside North America.

The funding from the NIH HEAL Initiative is to further develop the company’s lead compound, KNX100, for the treatment of opioid withdrawal. KNX100 is a drug that was discovered by researchers at the University of Sydney that is being commercialised by Kinoxis Therapeutics. of the Brain and Mind Centre and School of Psychology at the University of Sydney and Head of Translational Science for Kinoxis Therapeutics is the scientific lead principal investigator on the grant. Professor Iain McGregor, also of the and School of Psychology, is a principal investigator.

The grant will provide a potential of up to $US4.6 million over four years to support the pre-clinical and clinical development of KNX100 for the treatment of opioid withdrawal. Opioid withdrawal is the state of severe physical and mental distress that rapidly emerges when someone stops using opioids or tries to cut down.

Preventable deaths

Opioid overdose is the number one cause of preventable deaths in the USA, killing more people than motor vehicle accidents. In Australia, opioids accounted for just over three deaths a day in 2018 and were linked to more than half of the drug induced deaths across the country. Poor management of opioid withdrawal is a major contributor to the development and maintenance of harmful opioid use.

KNX100 is a small molecule therapeutic drug candidate being developed by Kinoxis to treat opioid-use disorder as well as a range of other substance use disorders and central nervous system disorders.

“This award provides the opportunity for Kinoxis to augment and accelerate the development of our lead compound, KNX100, into human clinical studies,” said , CEO of Kinoxis

“The award is recognition by the US ³Ô¹ÏÍøÕ¾ Institute on Drug Abuse and the NIH of KNX100’s potential to successfully manage opioid withdrawal symptoms and help curb the opioid crisis. Kinoxis is pleased to be partnering with the world’s leading research institute on substance use disorders on this project”.

The University of Sydney Deputy Vice-Chancellor (Research) Professor Duncan Ivison said: “We are delighted to see this major investment and vote of confidence in the next stage of Kinoxis’s work to tackle a major public health burden. Born out of outstanding basic research conducted at the University of Sydney and developed in close collaboration with our funding partner Uniseed, Kinoxis is a terrific example of leading Australian research being commercialised and developed in Australia, but also attracting global attention.”

NIH Director Francis S. Collins MD PhD, who launched the HEAL Initiative in 2018, said: “It’s clear that a multi-pronged scientific approach is needed to reduce the risks of opioids, accelerate development of effective non-opioid therapies for pain and provide more flexible and effective options for treating addiction to opioids. This unprecedented investment in the NIH HEAL Initiative demonstrates the commitment to reversing this devastating crisis.”

About Kinoxis Therapeutics

Kinoxis Therapeutics Pty Ltd was spun out of the University of Sydney in February 2018 through a funding round led by Uniseed (), a venture fund operating at the universities of Melbourne, Queensland, New South Wales and Sydney, as well as the CSIRO, with investment capital provided by these research organisations.

Kinoxis is developing a range of novel therapeutic small-molecule compounds for the treatment of substance use disorders and other central nervous system disorders. The company has licensed these compounds from the University of Sydney, with the lead candidate demonstrating potent anti-addictive and prosocial effects in several different animal models and is progressing through pre-clinical testing.

Substance-use disorders, including the abuse of alcohol, nicotine, illicit and prescription drugs, represent a considerable treatment challenge for health-care professionals. There are currently only a limited number of drugs approved for the treatment of substance use disorders. The compounds licensed are the result of a collaboration between the School of Chemistry and School of Psychology, through projects led by Professor Michael Kassiou, Professor Iain McGregor and Dr Michael Bowen. The primary target of the company is the brain oxytocin system, which is the focus of much interest because of its central role in the positive regulation of social behaviour and its inhibitory effects on addictive behaviours.

About the NIH HEAL Initiative

The ³Ô¹ÏÍøÕ¾ Institutes of Health launched the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, in April 2018 to improve prevention and treatment strategies for opioid misuse and addiction and enhance pain management. The NIH HEAL Initiative aims to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose and achieve long-term recovery from opioid addiction.