injectable pentosan polysulfate sodium (iPPS)

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‘We’re a Phase III company now’: HotCopper users bullish as Paradigm kicks off major osteo trial
The Market Online· 2025-09-30 02:07
Core Viewpoint - Paradigm Biopharma has initiated its final-stage Phase 3 trial for injectable pentosan polysulfate sodium (iPPS) aimed at treating osteoarthritis in knee joints, with participants being dosed in both Australia and the U.S. [1] Group 1: Trial Progress and Recruitment - A larger-scale recruitment campaign is underway, with current participants considered early patients, and the company is expanding the number of trial sites to maximize recruitment [3] - The company has launched a trial-specific website named 'Hope4OA' to support the recruitment efforts [4] - Nearly all trial sites are expected to be activated and recruiting by the end of October, positioning the company to meet its enrollment targets and deliver an interim analysis by mid-2026 [6] Group 2: Regulatory Feedback and Screening - Following feedback from the FDA, the company has improved its collective screening failure rate for the current Phase 3 trial iteration, named PARA_OA_O12 [4] - The early site start-up focused on comprehensive site initiation and imaging certification to ensure effective screening and enrollment at scale [5]