Kinoxis Therapeutics Awarded NIH HEAL Initiative Grant to Advance KNX100 for the Treatment of Opioid Withdrawal

MELBOURNE,Australiaand SYDNEY,Sept. 30,2019 --KinoxisTherapeutics Pty Ltd,a pre-clinical stage biotechnology company developing novel therapies for substance use disorders and other central nervous system disorders,has been awarded a major grant from the US National Institutes of Health,National Institute on Drug Abuse (NIH/NIDA). Theaward has been made under The Helping to End Addiction Long-term,or NIH HEAL Initiative,with the potential of up to $US4.6 million ($A6.8 million) of funding to support the pre-clinical and clinical development of Kinoxis Therapeutics' lead compound,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. Opioid overdose is the number one cause of preventable deaths in the US,killing more people than motor vehicle accidents.In Australia,opioids accounted for just over 3 deaths per 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.

The NIH HEAL Initiative was launchedin April 2018 to improve prevention and treatment strategies for opioid misuse and addiction and enhance pain management. The 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.Kinoxis's award is one of 375 grant awards made by the National Institutes of Health in fiscal year 2019 to apply scientific solutions to reverse the opioid crisis,andthe only one received outside North America.

The grant award received by Kinoxis will provide the company with up to US$4.6 million of funding,depending on the achievement of certain development milestones. The funding is to support a range of activities including the completion of the company's pre-clinical,IND-enabling program for KNX100,and a Phase 1 Safety Study in healthy volunteers.

KNX100 is a small molecule therapeutic drug candidate being developed for a range of substance use disorders,including opioid use disorder. The compound was discovered by researchers at the University of Sydney and provides a highly novel approach for treating opioid use disorder and has demonstrated potent anti-addictive properties in numerous pre-clinical models. The company was spun out from the University in February 2018 in a process led by venture fund Uniseed and with investment from several family offices and high net worth investors.

"This award provides the opportunity for Kinoxis to augment and accelerate the development of our lead compound,into human clinical studies," said Mr Hugh Alsop,CEO of Kinoxis Therapeutics. "The award is recognition by NIDA and the NIHof KNX100'spotential to successfullymanageopioid withdrawal symptomsand help curb the opioid crisis."

Kinoxis Chairman and Uniseed CEO,Peter Devine added: "We are pleased to be partnering with the world's leading research institute on substance use disorders on this project."

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 (www.uniseed.com),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 organizations.

Kinoxis is developinga 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.

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