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Paradigm Biopharmaceuticals finishes trial enrolment
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Paradigm Biopharmaceuticals finishes trial enrolment

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  • Paradigm Biopharmaceuticals completes patient recruitment for its Phase 3 knee osteoarthritis trial, reaching 538 participants across 65 global clinical sites.
  • Following the announcement, the Paradigm Biopharmaceuticals share price was down 3.03% at $0.16.
  • The company states that available capital will support upcoming interim analysis and primary endpoint results expected in early 2027.

Paradigm Biopharmaceuticals (ASX:PAR) completed patient enrolment in its global Phase 3 study of Zilosul for knee osteoarthritis pain with 538 participants starting treatment.

The final cohort surpassed the initial target of 466 participants after eligible candidates undergoing screening received permission to finish enrolment.

"Completion of enrolment removes a major operational milestone and enables the company to focus on treatment completion, patient follow-up, data preparation and delivery of the upcoming interim analysis," said Paradigm Biopharmaceuticals Executive Chair Paul Rennie.

Database lock and data preparation for a pre-specified interim analysis are scheduled during August ahead of an independent safety board review targeted for September.

The company stated that available capital is expected to support the interim analysis, top-line results, and commercial-readiness work.

Following the announcement, the Paradigm Biopharmaceuticals share price was down 3.03% at $0.16.

The business previously raised $21.4 million through an institutional placement and share purchase plan while maintaining a dual clinical research organisation operational model.

Management also continued regional and global licensing discussions for Zilosul at the BIO International Convention 2026 while advancing a 12-month research collaboration regarding bone marrow lesions.

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