How Paradigm’s New Oral Therapy Could Transform Early Osteoarthritis Treatment

Strategic Acquisition Broadens Osteoarthritis Portfolio

Paradigm Biopharmaceuticals Ltd (ASX – PAR) has taken a significant step to diversify its osteoarthritis (OA) treatment pipeline by acquiring Proteobioactives Pty Ltd. This move secures exclusive global rights to a patented oral combination therapy of pentosan polysulfate sodium (PPS) and a COX-2 inhibitor, branded as Pentacoxib™. The acquisition complements Paradigm’s ongoing injectable PPS (iPPS) phase 3 program, which targets moderate to severe OA, by enabling expansion into early-stage, mild OA segments and veterinary applications.

The oral combination therapy aims to address a large unmet need in patients with minor OA symptoms, including hand and mild knee OA, where treatment options remain limited. Importantly, preliminary pilot clinical data indicate meaningful improvements in pain, joint function, and reduced reliance on analgesics compared to COX-2 inhibitor alone, suggesting enhanced efficacy and safety potential.

Scientific Rationale and Market Opportunity

The combination therapy leverages the complementary mechanisms of PPS and COX-2 inhibitors. PPS is thought to act as a disease-modifying osteoarthritis drug (DMOAD), potentially slowing joint deterioration, while COX-2 inhibitors reduce inflammation and pain. Notably, the combination may allow for lower doses of COX-2 inhibitors, addressing safety concerns associated with long-term NSAID use.

With osteoarthritis affecting over 500 million people globally and a veterinary market growing rapidly, particularly among dogs and horses, the acquisition opens multiple commercial avenues. The global COX-2 inhibitor market alone is projected to reach over USD 11 billion by 2030, driven by rising musculoskeletal disorders.

Milestone-Driven Acquisition Terms and Development Pathway

Paradigm’s acquisition involves an upfront cash payment of AUD 500,000 and milestone payments totaling up to AUD 16 million, contingent on successful phase 2 and phase 3 clinical trials, FDA approval, and first commercial sales. The company plans to initially focus on veterinary development, where regulatory pathways may be more streamlined and data can support subsequent human clinical trials.

Paradigm’s Managing Director, Paul Rennie, emphasized that while the acquisition broadens the company’s long-term strategy, the primary focus remains on completing the injectable PPS phase 3 trial. The staged approach balances capital discipline with portfolio expansion, aiming to deliver new non-opioid chronic pain treatments across the OA severity spectrum.

Implications for Patients and Veterinary Medicine

For human patients, the oral Pentacoxib™ product could provide a convenient, well-tolerated alternative for early OA management, potentially delaying or reducing the need for injectable therapies. In veterinary medicine, the oral formulation may offer a cost-effective, easier-to-administer option compared to existing injectable treatments, improving compliance and safety for companion animals suffering from OA.

Overall, this acquisition positions Paradigm to address a broader range of OA patients and animal health markets, leveraging patented technology with promising early clinical evidence.