Paradigm Biopharmaceuticals Ltd (ASX:PAR) has secured a full study cohort for its Phase 2 trial evaluating the effect of pentosan polysulphate sodium (PPS or Zilosul®) on synovial fluid biomarkers associated with osteoarthritis pain, inflammation, and disease progression.
This Phase 2 (PARA_OA_008) clinical trial aims to provide evidence that disease specific biomarkers in the synovial fluid of symptomatic osteoarthritis (OA) patients are a potential marker of Zilosul’s effect on the joint.
The study will assess 60 subjects who have been randomised into either a twice weekly, once weekly, or placebo dosage group.
Paradigm expects to release top-line data from endpoints on day 56 in the third quarter of this calendar year, with data updates to be released at the 6-month and 12-month timepoints.
“Reached an important milestone”
“We have reached an important milestone with 100% completed recruitment in our PARA_OA_008 clinical trial,” Paradigm Biopharma chief medical officer Dr Donna Skerrett said.
“We thank all our volunteer trial participants, research physicians and their staff, and our dedicated and enthusiastic clinical staff for their time and commitment to this important study.
“Paradigm looks forward to sharing early data outcomes in third quarter 2022 from this exciting exploratory study as well as our continued progress in the ongoing global Phase 3 clinical trial.”
In parallel with this Phase 2 clinical trial, Paradigm is conducting a study into the effect of Zilosul on naturally occurring OA in dogs at the U-Vet Werribee Animal Hospital.
In the proposed trial, up to 21 dogs with OA of the stifle joint will be treated with 3 milligrams per kilogram of weight of Zilosul or placebo via subcutaneous weekly injection for 6 weeks.
The company is looking at outcomes of pain and function in particular, together with structural changes from baseline OA scores measured by X-ray, bone marrow lesions and cartilage volume by MRI.
In addition, molecular biomarkers associated with inflammation, cartilage degradation, and pain will be assessed in the synovial fluid and serum, as in the human trial.
A 20-week follow up will assess the durability of response and structural changes following therapy.
Paradigm believes the collective analyses of pain, function, joint structure, and biomarker levels following PPS therapy will provide data to assess the potential of PPS as a disease-modifying osteoarthritis drug in humans.