- Paradigm Biopharmaceuticals (PAR) has made amendments to its clinical trial protocol for knee osteoarthritis treatment
- The company submitted the changes to the Human Research Ethics Committee, which included the addition of a test site in NSW, a once-weekly dosing regimen and an extension to its patient follow-up
- Following these amendments, the timeline for primary analysis readout has been adjusted to Q3 2022
- Meanwhile, Paradigm is also conducting a trial for dogs with naturally occurring osteoarthritis, following ethics approval
- Paradigm Biopharmaceuticals is up 2.64 per cent, trading at $1.95
Paradigm Biopharmaceuticals (PAR) has made amendments to its clinical trial protocol for knee osteoarthritis treatment.
Paradigm’s phase two clinical trial will evaluate participants with knee osteoarthritis (OA) pain, investigating the effects of pentosan polysulphate sodium (PPS) against a placebo on synovial fluid biomarkers.
Pentosan polysulfate sodium (PPS) is a medication that has been used in humans for over 60 years. However, injectable PPS is still under evaluation by Paradigm for the treatment of osteoarthritis and other inflammatory diseases in the US and other global markets.
The randomised, double-blind, placebo-controlled phase two study will enrol 60 patients and hopes to provide evidence that certain biomarkers are more prevalent in the synovial fluid of symptomatic OA patients with radiographic evidence of joint damage.
The company submitted its trial changes to the Human Research Ethics Committee.
The amendments included an additional test site in Newcastle in New South Wales to assist with the recruitment of the remaining thirty patients.
The company also added a once-weekly dosing regimen study to evaluate the effects of the biomarkers compared to twice weekly regimen and placebo.
Originally, Paradigm planned to assess key secondary and exploratory endpoints in the phase two study to six month or Day 168. However, the company’s final change to the trial saw it extend its patient follow-up to 12 months. This change was made to gather pilot data for the medium-long term combined structure-modifying and symptom modifying effects of PPS on knee OA.
The decision follows a research report which indicated that demonstration of a durable effect on pain, function, and long-term data would help boost the company’s potential to receive government funding.
Following these amendments, the timeline for primary analysis readout has been adjusted to Q3 2022.
Meanwhile, Paradigm is also conducting a trial in dogs with naturally occurring osteoarthritis following ethics approval.
“The combined information of these two studies will allow us to assess the potential disease modification capability of our OA program while we initiate the phase 2/3 pivotal study activity to assess PPS safety and efficacy for the pain and function indication,” Paradigm Chief Medical Officer Dr Donna Skerrett said.
Paradigm Biopharmaceuticals was up 2.64 per cent, trading at $1.95 at 12:00 pm AEDT.