- Paradigm Biopharmaceuticals (PAR) has enrolled its first patient in its knee osteoarthritis (OA) biomarker study in Box Hill, Victoria
- The participant in the PARA_OA_008 study was selected at random and has begun study procedures to collect baseline biomarker synovial fluid information
- The study is designed to generate clinical data to examine the potential of Paradigm’s Zilosul candidate to treat osteoarthritis
- Sixty participants will be enrolled in the study and randomised to receive either pentosan polysulfate sodium or a placebo
- Participants have begun the screening process for the study and may begin the treatment phase over the next few weeks.
- The company expects to announce the results of the second study in the second half in the calendar year
- Company shares last traded at $2.57 on April 13
Paradigm Biopharmaceuticals (PAR) has enrolled its first patient in its knee osteoarthritis (OA) biomarker study in Box Hill, Victoria.
The participant in the PARA_OA_008 study was selected at random and has begun study procedures, including join aspiration to collect baseline biomarker synovial fluid information. The patient has received the first dose of either injectable pentosan polysulfate sodium (iPPS) or a placebo and will continue to receive two injections under the skin a week for a six-week period.
The study is designed to generate clinical data which will inform Paradigm of the potential its Zilosul candidate has as a first-in-class Disease Modifying Drug for Osteoarthritis.
Paradigm previously reported ethics approval and trial design for its knee OA biomarker study, which will measure the change in synovial fluid biomarkers associated with pain, inflammation and osteoarthritis disease progression.
It will follow treatment with injections of pentosan polysulfate sodium, compared with subcutaneous injections of placebo in participants with knee OA.
Sixty participants will be enrolled in the study and randomised to receive either iPPS or a placebo.
Participants have begun the screening process for the study and, subject to meeting inclusion criteria, may begin the treatment phase over the next few weeks.
“We are very pleased to have progressed to the treatment phase of the knee synovial fluid Biomarker study, by dosing of the first participant,” said Paradigm CEO and Chairman Paul Rennie.
“This study has been designed to generate clinical data which will inform of the potential of Zilosul as the first in class disease modifying OA drug. Additionally, the data generated will form part of Paradigm’s submission package to the TGA for the next step of the provisional approval application”.
The company expects to announce the results of the second study in the second half in the calendar year.
Company shares last traded at $2.57 on April 13.