Australian company Kinoxis Therapeutics has been awarded a UH3 grant by the National Institute on Drug Abuse (NIDA), part of the US National Institutes of Health (NIH).
The grant is expected to provide approximately US$3.6 million over three years to support the Phase 1 clinical development of the company’s lead molecule, KNX100, to treat 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.
The company said the new funding was secured after the company completed the milestones defined in an earlier UG3 grant received from NIDA in 2019 under the US government's Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative.
In the 12 months to December 2022, more than 105,000 people in the US died of a drug overdose, with 75 per cent of those deaths involving an opioid, according to recent data from the US Centers for Disease Control and Prevention.
KNX100 is one of only a few novel molecular entities in active clinical development for treating 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, the 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. The double-blind, placebo-controlled, randomised study is investigating the safety, tolerability, and pharmacokinetics of repeat daily administration of KNX100 in healthy volunteers.