Paradigm Biopharmaceuticals has secured $16 million through a placement to institutional and sophisticated investors to support the initiation of its Phase III clinical trial, PARA_OA_012, evaluating the efficacy of its drug candidate, pentosan polysulfate sodium (iPPS), for the treatment of knee osteoarthritis. The funding is expected to provide the company with sufficient cash reserves to commence the trial and maintain working capital into the second half of calendar year 2025.
Trial Design and Objectives
The Phase III trial is designed to demonstrate the improvement in pain and function with subcutaneous injections of iPPS compared to placebo in patients diagnosed with clinical and radiographic knee osteoarthritis who have shown inadequate response to conservative therapies. The trial will involve global site initiation, commencing in Australia in Q1 2025, followed by the US in Q2 2025.
The study will run for up to 64 weeks, including a six-week treatment period. Patients will be assessed twice weekly during treatment, with follow-up visits every 4-6 weeks during the 52-week follow-up period. The primary endpoint is the change from baseline in knee pain at day 112, measured using the 11-point numerical rating scale for weekly average daily pain.
Secondary Endpoints and Assessments
In addition to the primary endpoint, the trial will evaluate several secondary endpoints, including changes in stiffness, quality of life, and the use of rescue medication from baseline through day 365. Long-term assessments of knee structure will be conducted via MRI and X-ray.
Prior Clinical Data
Paradigm's Phase II clinical trial data indicated that a six-week course of subcutaneous iPPS could provide 12-month pain relief and improved function in patients with knee osteoarthritis.
Financial Runway and Future Plans
Following the placement, Paradigm forecasts a pro forma cash balance of $29.6 million. The company also intends to seek non-dilutive funding through partnering or regional licensing deals to further extend its financial runway. Furthermore, the company intends to issue loyalty options, which, if fully exercised, could raise an additional A$63.3 million by early CY26.
Management Commentary
Paradigm managing director Paul Rennie stated that the capital raised provides the company with sufficient cash reserves to commence the Phase III clinical trial and maintain working capital into H2 CY25. He also highlighted the support from current and new investors, emphasizing the strength of Paradigm's clinical programs.
