Paradigm Biopharmaceuticals Ltd. ((PBIGF)) announced an update on their ongoing clinical study.
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Study Overview: Paradigm Biopharmaceuticals Ltd. is conducting a Phase 3 clinical trial titled ‘A Phase 3, Randomised, Double-Blind, Placebo-Controlled Multi-Centre Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared to Placebo in Participants With Knee Osteoarthritis Pain.’ The study aims to assess the efficacy of pentosan polysulfate sodium (PPS) in reducing pain and improving function in adults with knee osteoarthritis, a condition affecting millions worldwide.
Intervention/Treatment: The study tests subcutaneous injections of pentosan polysulfate sodium (PPS) at a dosage of 2 mg/kg twice weekly for six weeks, compared to a placebo (sodium chloride injection). PPS is intended to alleviate pain and improve joint function in knee osteoarthritis patients.
Study Design: This is a randomized, double-blind, placebo-controlled study with a parallel intervention model. Participants, care providers, investigators, and outcomes assessors are masked to the treatment allocation. The primary purpose is to evaluate the treatment effect of PPS in knee osteoarthritis.
Study Timeline: The study began on March 11, 2025, with a primary completion date yet to be announced. The latest update was submitted on July 17, 2025. These dates are crucial as they indicate the study’s progress and potential timeline for results.
Market Implications: The ongoing study by Paradigm Biopharmaceuticals could significantly impact the company’s stock performance and investor sentiment, especially if PPS proves effective. Success in this trial could position Paradigm as a leader in osteoarthritis treatment, potentially affecting competitors in the pharmaceutical industry.
The study is currently recruiting, with further details available on the ClinicalTrials portal.