Patient Recruitment Challenges Threaten Tissue Repair’s Phase 3 Timelines

Clinical Trial Progress and Challenges

Tissue Repair Limited (ASX – TRP) has provided a comprehensive update on its June 2025 quarter activities, highlighting ongoing efforts in its Phase 3 clinical trials for TR987®, a drug candidate targeting chronic wounds such as venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The company has selected 44 trial sites across the US and Australia, with 29 initiated and 25 activated, yet patient recruitment remains slow with only 10 patients randomised so far.

This sluggish enrolment is attributed to significant disruption in the US wound care market following new Medicare reimbursement requirements demanding randomised controlled trial data. This has triggered a surge in sponsor-initiated trials, intensifying competition for eligible patients and causing delays across the sector. Tissue Repair acknowledges these challenges but remains confident in strategies to boost enrolment, including leveraging large institutional sites with high patient volumes.

Regulatory Strategy and Manufacturing Advances

In response to the evolving regulatory landscape, Tissue Repair is pursuing a dual pathway for TR987® in the US – continuing the Phase 3 drug approval process while preparing a 510(k) device application for TR Pro+® to enable earlier market entry in dermatology and chronic wound indications. This device pathway was not available at the time of the company’s IPO and represents a strategic pivot to accelerate commercialisation.

On the manufacturing front, the company is refining production processes for its proprietary Glucoprime® active pharmaceutical ingredient (API), with five new batches underway that have improved yields and efficiency. A new manufacturing partner capable of commercial-scale production has been identified, with a long-term supply agreement expected imminently, securing the supply chain for TR Pro+® expansion.

Commercial Momentum and Global Expansion

TR Pro+®, Tissue Repair’s topical gel for aesthetic and medical wound care, continues to gain traction. The product achieved record monthly sales in Q2 2025, with quarterly revenue doubling compared to Q1, driven by repeat orders and onboarding of new clinics. To support broader market penetration, Tissue Repair has inked a multi-year distribution deal with Advanced Cosmeceuticals Pty Ltd, granting access to over 2,500 clinics, major pharmacy chains, and e-commerce platforms across Australia and New Zealand.

Internationally, the company signed its first overseas distribution agreement with Amellie and Proud Co., Ltd for exclusive rights in Thailand, targeting premium dermatology and aesthetic clinics. Additionally, Tissue Repair is actively pursuing CE mark certification to facilitate entry into European and other global markets recognizing this regulatory standard.

Financial Position and Outlook

Financially, Tissue Repair reported a solid cash position of $12.3 million at quarter-end, supported by positive net operating cash flow primarily due to a $1.8 million R&D tax refund and increased TR Pro+® sales revenue of $140,000 for the quarter. Operating expenses remain aligned with budget forecasts, reflecting prudent management as the company balances clinical development and commercial expansion.

Looking ahead, the company plans to complete the current Glucoprime® API batches, advance the 510(k) device application, and accelerate patient enrolment in its Phase 3 trials. The commercial rollout of TR Pro+® will continue to scale domestically and internationally, with a focus on expanding product formats and entering new markets.