Paradigm Submits Phase 3 OA Program to FDA

Paradigm Biopharmaceuticals Ltd. (AU:PAR) has released an update.

Paradigm Biopharmaceuticals Ltd. has made significant strides by submitting a comprehensive package, including new nonclinical study results and phase 2 clinical trial data, to the US FDA in hopes of advancing its phase 3 osteoarthritis program. The submission includes a draft protocol for the upcoming pivotal trial and a revised safety plan, with the company aiming to commence patient enrollment in the second half of 2024, pending FDA feedback. Additionally, Paradigm is preparing for TGA provisional approval in Australia, which could accelerate access to their innovative osteoarthritis treatment and potentially lead to earlier revenue generation.

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