Paradigm Biopharma advances Phase 3 OA Trial on tail of positive DSMB safety review

Late-stage drug developer Paradigm Biopharmaceuticals (ASX:PAR) has announced its pivotal Phase 3 PARA_OA_012 clinical trial will “proceed as designed” after a scheduled safety review went off without a hitch. The independent Data Safety Monitoring Board completed an assessment of the first 20% of participants, confirming the trial’s continuation toward full recruitment targets.

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The DSMB’s review focused on ~20% of first participants who completed their dosing regimen by Day 39. As an independent committee, the DSMB was tasked with monitoring safety while ensuring the scientific validity.

The completion of this early milestone “supports the continued execution of the PARA_OA_012 study,” which is evaluating injectable pentosan polysulfate sodium (iPPS) for patients with knee osteoarthritis.

The trial was randomised, Paradigm said, in a double-blind, placebo-controlled multicentre study aiming for a total recruitment of around 466 participants.

“The DSMB has provided us with an in-depth review of the safety profile of iPPS in this study,” Paradigm’s Chief Medical Officer, Dr Donna Skerrett, said. “With recruitment advancing at pace and additional sites coming online, we are well positioned to complete enrolment and interim analysis in the coming months, which will provide important assessment of treatment effect at Day 112.”

With recruitment progressing, HotCopper understands that Paradigm is on schedule for its primary interim analysis. That particular analysis is planned for August CY26, though the company has noted it could extend into early September CY26, depending on any data cleaning and biometric processing.

Heading into Thursday, PAR is selling at 17.5cps.

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