Dendright announces first human dose of DEN-181 in phase 1b Clinical Trial
Dendright Pty Limited, a clinical-stage biotechnology company developing a first-in-class immunotherapy for the treatment of rheumatoid arthritis today announced it has commenced first-in-human dosing of its product candidate, DEN-181 in a Phase 1b clinical trial.
Dendright CEO, Helen Roberts commented, “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”.
The double-blind, placebo-controlled study has both single-ascending dose and multi-dose protocols and is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous delivery of DEN-181. The study will be conducted in anti-CCP+ rheumatoid arthritis patients on methotrexate at Brisbane’s Translational Research Institute (TRI) Clinical Research Facility located on the Princess Alexandra Hospital (PAH) campus.
Professor Ranjeny Thomas, Dendright CSO and Arthritis Queensland Chair of Rheumatology at the University of Queensland’s Diamantina Institute commented, “Phase 1 studies provide the bridge to bring scientific data into clinical practice. The study team will be undertaking detailed monitoring to assess DEN-181 safety and immunological response in RA patients and we thank patients and referring rheumatologists in advance for their engagement in Phase 1 clinical development of this new treatment”.
The Phase 1 study of DEN-181 is being conducted under an Australian Clinical Trial Notification (CTN). The trial will be led by Dr. Phillip Vecchio and Dr. Amee Sonigra from the PAH Rheumatology Department. In 2013, Dendright entered into a Research Collaboration and Option to License Agreement with US-based Janssen Biotech, Inc. and in 2016 the parties extended that agreement to cover funding for a Phase 1 clinical trial.
“We anticipate the study to read-out first results from the single-ascending dose cohorts in mid-2018 and we will evaluate safety, tolerability and immunodulatory data from all subjects to refine the dosing to take forward in the multi-dose protocol” said CEO Helen Roberts. “The clinical development path for DEN-181 will be further refined as we better understand the immunomodulation possible with DEN-181 in rheumatoid arthritis patients”.
Further details of the study including patient eligibility criteria are available at www.anzctr.com using search term ‘Dendright’.
Enquiries regarding study criteria can also be directed to [email protected].
About DEN-181
DEN-181 is a nanoparticle-based immunotherapy designed to regulate activated immune cells which cause inflammation, pain and joint damage in rheumatoid arthritis. Laboratory studies have shown that activated immune cells can be regulated in an antigen-specific manner through nanoparticle-delivered signals. DEN-181 has the potential to offer higher specificity of effect and lower toxicity than current treatments for RA given the lack of broadly suppressive effects on the immune system.
About Dendright
DEN-181 was discovered and developed by researchers at the University of Queensland and commercialised by UniQuest through a start-up company, Dendright Pty Ltd.
Arthritis Queensland, a key Queensland-based not-for-profit organisation focused on the needs of patients with arthritis, contributed funding to support the clinical program.
About Arthritis Queensland
Arthritis Queensland (inc. Osteoporosis Qld) is a not-for-profit organization, providing education, information, and support services for the more than a million Queensland children and adults living with arthritis or osteoporosis.
Arthritis Queensland also provides financial support for research into treatments, and ultimately a cure for the more than 100 forms of arthritis.
