Dendright advances immunotherapy

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Dendright, a company spunout of the University of Queensland, has announced it has commenced first-in-human dosing of its product candidate, DEN-181 in a Phase 1b clinical trial. 

The Phase 1 study of DEN-181, a first-in-class immunotherapy for the treatment of rheumatoid arthritis, is subject to a collaboration and license agreement with Janssen.

The trial will be led by Dr Phillip Vecchio and Dr Amee Sonigra from the PAH Rheumatology Department.

According to Dendright CEO, Helen Roberts, “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 campus. 

Professor Ranjeny Thomas, Dendright CSO and Arthritis Queensland Chair of Rheumatology at the University of Queensland’s Diamantina Institute, said, “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.”

Ms Roberts continued, “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.

“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.”