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Paradigm Biopharmaceuticals (ASX: PAR) has entered into a binding term sheet with AVet Health to co-develop and license a novel oral combination therapy for the treatment of osteoarthritis (OA) in companion animals.
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The therapy features a novel combination of pentosan polysulfate sodium (PPS) and a COX-2 inhibitor.
MD, Paul Rennie, said the agreement provides Paradigm with a pathway to progress this promising asset in the animal health sector while remaining fully focused on its pivotal Phase 3 PARA_OA_012 clinical trial for knee osteoarthritis.
“This agreement enables early generation of formulation and preclinical data that could support both a faster veterinary regulatory pathway via the APVMA and also provide data for our longer-term regulatory package in humans,” Mr Rennie said.
“Importantly, this is being done in a capital-efficient manner, allowing Paradigm to remain fully focused on our pivotal Phase 3 clinical trial of Zilosul and ongoing commercial interest as we prepare for the interim analysis.”
Paradigm acquired the intellectual property for the PPS and COX-2 inhibitor combination in 2025 as part of a strategic expansion of its osteoarthritis portfolio.
Mr Rennie said the acquisition was a key step in progressing the formulation as an oral, non-opioid therapy for the treatment of osteoarthritis in veterinary and human health, with a focus on earlier-stage disease.
“This oral formulation represents a first-in-class approach, combining PPS, a compound with potential disease-modifying benefits, with a COX-2 inhibitor to reduce inflammation and pain. This dual-action candidate is differentiated from injectable PPS products already marketed in the veterinary space, and may offer improved convenience, safety, and compliance for long-term OA management.”
Paradigm will fund the veterinary development program through a multi-stage development plan, with Stage 1 activities, including formulation development and initial non-clinical work, estimated to cost approximately $1 million.
AVet will contribute in-kind resources, including project management and scientific oversight, and supply and access to the Drug Master File of commonly used COX-2 inhibitors in the veterinary space, as part of this initial development phase.
AVet is a veterinary pharmaceutical company which has registered more than 95 products with the Australian Pesticides and Veterinary Medicines Authority (APMVA).
Osteoarthritis remains a major cause of pain and reduced mobility in companion animals.
PAR is up 3.45% to 30.0c, Mkt cap $124.2M.
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