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Paradigm Biopharma (ASX:PAR) has officially passed a milestone that gives investors in the company a ‘fast-track’ path to topline data from a Phase III trial investigating osteoarthritis using the company’s injectable drug iPPS.
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That ‘fast-track’ looks like this: now that Paradigm has signed up 50% of patients to its global Phase III trial – the be-all-and-end-all final stage clinical study for all biopharma companies ahead of final FDA and/or TGA approval – investors will be able to digest interim data as early as August CY26.
In other words, investors will be getting an idea of the efficacy of the company’s drug in Q3 of CY26, instead of having to wait for the entire trial to wrap up.
That offers multiple benefits: A balm for the impatient; enough time to ride out the current (and hopefully temporary) Iran-based volatility, and an opportunity to enhance the Phase III study further beyond interim data collection.
“The PARA_OA_012 study is designed to enrol 466 participants globally, with patients randomised to receive injectable pentosan polysulfate sodium (iPPS) or placebo,” the company wrote on Tuesday.
“The primary endpoint of the study is the change in weekly average of daily pain at Day 112, with secondary endpoints including improvements in physical function, imaging-based structural outcomes, and safety assessments.”
Paradigm chief Paul Rennie went further in highlighting Paradigm’s strong clinical position at this juncture. “The trial design closely mirrors our earlier PARA_OA_008 study in terms of patient population and dosing regimen, while incorporating important refinements developed in consultation with regulatory agencies and leading scientific advisors,” Rennie told shareholders this morning.
“These improvements, including the use of weekly average of daily pain recordings alongside continued WOMAC assessments, are intended to strengthen the study’s ability to detect clinically meaningful treatment effects while managing placebo response, which is a recognised challenge in osteoarthritis clinical trials.”
PAR last traded at 26.5cps.
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