Paradigm Biopharma Advances Phase 3 Trial with FDA Nod and $16M Raise

Regulatory Milestone Achieved

Paradigm Biopharmaceuticals Ltd (ASX: PAR) has marked a significant regulatory achievement with the U.S. Food and Drug Administration (FDA) completing its 30-day review of the company's revised phase 3 clinical trial protocol for PARA_OA_012 without any questions or requests for clarification. This clearance enables Paradigm to proceed with the pivotal trial aimed at evaluating its iPPS therapy for moderate to severe knee osteoarthritis.

The FDA's smooth acceptance of the protocol underscores the robustness of Paradigm's clinical development strategy and reflects the company's thorough engagement with regulatory authorities during the trial design phase.

Streamlining Australian Trial Initiation

In parallel, Paradigm has submitted its centralised ethics application in Australia via the national Human Research Ethics Committee (HREC) pathway. This streamlined process is expected to accelerate site activations and patient recruitment across up to 10 Australian clinical sites. Ethics approval is anticipated in the first quarter of 2025, aligning with the company’s timeline to commence patient enrolment activities imminently.

Robust Financial Position Supports Clinical Ambitions

Financially, Paradigm has fortified its position through a successful $16 million placement to institutional and sophisticated investors, issuing 40 million shares at $0.40 each, a slight premium to recent trading levels. This capital injection, combined with a $6.3 million R&D tax incentive rebate from the Australian government, has boosted the company’s cash reserves to approximately $31 million.

These funds are earmarked for critical phase 3 trial activities, including global trial setup, site recruitment, manufacturing, regulatory studies, and working capital. Operating expenses for the December quarter were notably controlled at $3.58 million, well below the guided $7 million, reflecting disciplined financial management as Paradigm scales up its clinical program.

TGA Endorses Traditional Registration Pathway

The Therapeutic Goods Administration (TGA) in Australia has reviewed Paradigm’s clinical data and determined that iPPS is suitable for entry into the therapeutic landscape through the traditional registration pathway rather than a provisional determination. This decision validates the strength of Paradigm’s existing clinical evidence and sets the stage for full registration upon successful completion of the phase 3 trial.

Looking Ahead: Phase 3 Trial and Commercial Prospects

Paradigm plans to enrol approximately 466 participants in a 1:1 randomisation design, focusing on pain reduction as the primary endpoint, supplemented by functional and structural assessments. An interim analysis is scheduled once half the participants complete 112 days of follow-up, providing an early read on efficacy and safety.

CEO Paul Rennie expressed optimism about the company’s trajectory, highlighting the combined impact of regulatory progress, financial strength, and operational readiness. The upcoming months will be critical as Paradigm activates clinical sites and initiates patient recruitment, initially in Australia with plans for global expansion.

Additionally, Paradigm is preparing a loyalty option program to reward shareholders, signaling confidence in its growth prospects and commitment to shareholder value.