* article from today (December 29)...PARADIGM...

* article from today (December 29)...

PARADIGM BIOPHARMACEUTICALS (ASX - PAR) Primarily focused on development of injectable pentosan polysulfate sodium (iPPS/Zilosul) for treatment of diseases such as osteoarthritis (OA) and mucopolysaccharidosis (MPS) – where inflammation plays a major pathogenic role.

PAR has several catalysts in 2024.PARGA provisional approval next year to market its lead drug iPPS in Australia for knee OA, providing potential significant revenues prior to the completion of its global pivotal Phase 3 study.

The provisional approval process involves PAR submitting a determination application to the regulatory body, which then has 30 days to accept if the company has acceptable data to proceed to the final stage of a full dossier submission.The determination application is expected to occur early in Q1 2024.If the TGA grants PAR provisional approval it would be likely in 2025, following full dossier submission).

PAR will also have the US FDA review clinical trial protocol to proceed to the next stage of its Phase 3 trial for knee OA in Q1 2024.The company says following agreement with the FDA, it will start recruitment and enrolment of about 600 subjects needed for the final stage of the trial.PAR currently has 120 clinical trial sites across seven countries on standby to recommence enrolment of subjects and expects the first subject in the next stage of its phase 3, to be randomised in Q2 2024.

And after open and active discussions with commercial partners to license iPPS for either OA or MPS in 2023 PAR is expecting to conclude one or more regional licensing deals in H1 2024, which the company says would be a significant catalyst for the share price and commercial validation of its product and clinical program.