Paradigm Biopharmaceuticals progresses in trial development

Paradigm Biopharmaceuticals (ASX:PAR) has made significant progress in its September 2024 Quarterly Activities Report by submitting the final protocol for its Phase 3 PARA_OA_012 trial to the US FDA. The focus is on treating knee osteoarthritis using iPPS. The review is expected to conclude by 28th November 2024, with patient enrolment anticipated to begin in early 2025.

Paradigm Biopharmaceuticals' strategic outlook

Paradigm Biopharmaceuticals is advancing its Phase 3 clinical trial for osteoarthritis treatment, with the final protocol submitted to the US FDA. The trial aims to assess the efficacy and safety of PPS 2 mg/kg for patients with knee osteoarthritis. Financially, the company reported a net cash outflow of $4.72 million, under its $7 million guidance, and expects a $5-6 million R&D incentive rebate. With a strong cash position of $13.14 million, Paradigm is well-positioned to continue its research activities. Strategic milestones include the conclusion of the FDA review by 28th November 2024 and commencing patient enrolment in early 2025. The transition of Dr. Donna Skerrett to solely the role of Chief Medical Officer highlights internal strategic adjustments. Paradigm remains committed to enhancing the visibility and scientific validation of iPPS through upcoming publications, while maintaining prudent fiscal management to support its osteoarthritis program.

Executive commentary on trial advancements

The protocol has been refined based on FDA feedback to enhance patient convenience and trial efficiency.