Paradigm Biopharmaceuticals Ltd.
🇦🇺Australia
- Country
- 🇦🇺Australia
- Ownership
- Public
- Established
- 2014-01-01
- Employees
- 51
- Market Cap
- -
Paradigm Partners with Advanced Clinical for Pivotal Phase III Osteoarthritis Trial
• Paradigm Biopharmaceuticals has selected Advanced Clinical as their CRO partner for PARA_OA_012, a Phase III trial evaluating injectable pentosan polysulfate sodium for knee osteoarthritis pain.
• The double-blind, multi-center study aims to enroll 466 subjects, with an interim analysis planned after day 112, building on promising Phase II results showing significant pain reduction.
• Trial initiation is scheduled for Q2 2025 across ten Australian sites, pending ethics approval, with initial sites being activated in Victoria.
Paradigm Biopharmaceuticals Advances Phase 3 Trial for Osteoarthritis Treatment
• Paradigm Biopharmaceuticals is preparing to submit a revised Phase 3 trial protocol to the FDA, focusing on patient convenience and cost reduction.
• The company has selected four global CROs and anticipates commencing patient enrollment in Australia by early 2025.
• Demonstrating confidence, Paradigm's board and staff have invested in company shares, signaling strong commitment to the clinical program.
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