Posted: 9 June 2023
Kinoxis Therapeutics is pleased to announce it has been awarded a UH3 grant by the National Institute on Drug Abuse (NIDA), part of the US National Institutes of Health (NIH), which is expected to provide approximately US$3.6 million over 3 years. The grant will be applied to funding the Phase 1 clinical development of Kinoxis’ lead molecule, KNX100, for the treatment of symptoms associated with withdrawal in patients with opioid use disorder. Kinoxis is a private, Australian based, clinical stage company developing novel therapeutics for substance use, neurological, and psychiatric disorders.
This new funding was secured after the company successfully completed the milestones defined in an earlier, UG3 grant received from NIDA in 2019 under the US Federal Government’s Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative.
Opioid use disorder is a crisis with major public health implications and overdose deaths involving opioids have claimed the lives of more than half a million people since 19991. In the 12 months to December 2022, more than 105,000 people in the United States died of a drug overdose, with 75% of those deaths involving an opioid, according to recent data from the US Centers for Disease Control and Prevention (CDC)2. These harrowing statistics reflect the scale of the crisis and the need for new treatments to address opioid withdrawal. KNX100 is currently one of only a small number of novel molecular entities in active clinical development for the treatment of opioid use disorder globally.
“Opioid use disorder is a major and worsening problem in the US and many other countries. New treatment options are needed for managing withdrawal symptoms and helping people to recover from opioid addiction.” said Hugh Alsop, co-founder and CEO of Kinoxis Therapeutics.
“We have an investigational therapy with significant potential in KNX100. The progression of our NIDA grant to the UH3 phase is an important milestone for Kinoxis as it represents further, significant external validation of the KNX100 program and provides the capital required to study key clinical safety endpoints.”
In February 2022 Kinoxis achieved clearance from the US Food and Drug Administration for an Investigational New Drug application for KNX100. The company has commenced a Phase 1, first in human clinical study which is in progress at Nucleus Network in Melbourne, Australia. The double blind, placebo controlled, randomized study is investigating the safety, tolerability, and pharmacokinetics of repeat daily administration of KNX100 in healthy volunteers. The Phase 1 study is expected to be completed in Q3 2023.
“To-date we’ve demonstrated KNX100 reduces opioid withdrawal symptoms in preclinical models through highly disease relevant actions in the brain and have now progressed to testing in humans with our Phase 1 safety study,” said Associate Professor Michael Bowen, co-founder and Chief Scientific Officer of Kinoxis Therapeutics. “We’re excited to continue working with NIDA on the clinical development of KNX100 for the treatment of opioid use disorder,” he concluded.
KNX100 is an oral, small molecule drug candidate in capsule form, with a novel mechanism of action which targets key brain regions critical to regulating withdrawal and addictive behaviors. Promising data has been obtained to date, demonstrating effects on drug withdrawal, consumption and relapse in preclinical models of opioid, cocaine, methamphetamine, nicotine, and alcohol use disorders. KNX100 has also shown considerable promise in preclinical models of agitation and aggression.
Kinoxis is backed by Uniseed, Australia’s longest running venture fund, and a consortium of sophisticated investors. The company has recently commenced a Series B financing round, which aims to raise up to A$16 million to fund three Phase 2 clinical trials for KNX100, in opioid withdrawal, methamphetamine use disorder, and the treatment of agitation and aggression in dementia patients. Research reported in this press release is supported by the National Institute on Drug Abuse of the National Institutes of Health under award number UH3DA048743. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
