Australia’s first in-human study of a first-in-class rheumatoid arthritis immunotherapy treatment developed by University of Queensland researchers was launched on November 14, 2017.
The Phase 1, double-blind, placebo-controlled study currently underway at Brisbane’s Princess Alexandra Hospital, will consider both single-ascending dose, and multi-dose protocols to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous (under the skin) delivery of “DEN-181” – a novel, vaccine-style treatment that targets the underlying cause of rheumatoid arthritis.
A research team at the University of Queensland’s Diamantina Institute developed DEN-181 after discovering the body’s immune system could be ‘re-educated’ to turn off, rather than react to, the self-antigen which attacks the body and results in rheumatoid arthritis.
Head researcher, Professor Ranjeny Thomas, said the phase 1b clinical trial served as the bridge to introducing scientific data into clinical practice, and expressed his thanks to patients and rheumatologists supporting the research.
“The study team will be monitoring and assessing DEN-181 safety and immunological response in patients, and we thank the participating patients and referring rheumatologists,” she said.
Dendright Pty Limited, a UniQuest-founded, clinical-stage biotechnology start-up (University of Queensland’s commercialisation arm), will bring the product to market.
Announcing the clinical trial, Dendright CEO, Helen Roberts said reaching human trials is a significant step in the development of DEN-181.
“The first human dosing of DEN-181 marks significant progress for the rheumatoid arthritis program and we wish to thank all of our many development partners for their commitment and dedication to enabling this clinical milestone.”
UniQuest CEO, Dr Dean Moss, said the first-in-human trial was a momentous step towards making the breakthrough research discovery a treatment reality.
“This is an important milestone in developing a new medicine for the millions of people affected by this debilitating disease which destroys joints, causes cardiovascular complications, and can reduce life-span.”
Funding for the clinical program is being provided by Arthritis Queensland, Janssen Biotech, Inc, and the University of QLD.
Find out more about DEN-181 and the clinical trial here.