Paradigm is focused on the development of injectable pentosan polysulfate (iPPS) for the treatment of osteoarthritis (OA). While the company has several active human clinical trials, it is also assessing iPPS in a canine model due to the similarities in disease biology. Furthermore, since dogs have a shorter lifespan than humans, the full progression of the condition can be assessed over a condensed period. Management believes that this could be advantageous in evaluating the disease-modifying OA drug (DMOAD) status of iPPS, a key goal for Paradigm. The latest data show that iPPS demonstrates durable effects on pain, function and cartilage volume in the canine OA model at the three-year human equivalent time point (canine 26 weeks). These positive results add to a growing data package to support iPPS as a potential DMOAD. Paradigm intends to present this to the FDA and EMA in H2 CY23, and the outcome of these discussions could represent a significant catalyst for the company, in our view.
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