TR Pro+® Sales Soar as TR987® Phase 3 Trial Faces Enrollment Delays

Phase 3 Trial Progress and Challenges

Tissue Repair Limited (ASX:TRP) has provided its March 2025 quarterly update, highlighting ongoing efforts to advance its lead drug candidate TR987® through Phase 3 clinical trials targeting chronic wounds such as venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The company has selected 34 clinical sites across the US and Australia, with 19 initiated and 13 activated. However, patient enrollment remains slow, with only four patients randomized so far. This sluggish recruitment is attributed to recent US regulatory disruptions, notably Medicare’s removal of reimbursement for many wound care devices due to insufficient clinical evidence, which has spurred a surge in competing clinical trials.

Despite these headwinds, Tissue Repair is optimistic about increasing enrollment through protocol amendments that have received ethics approval, engagement with larger institutional clinics, and targeted local advertising. The company underscores that it remains the only sponsor globally with a drug in Phase 3 trials for VLUs, positioning TR987® uniquely in a market increasingly demanding robust clinical data.

Regulatory and Manufacturing Developments

On the regulatory front, Tissue Repair has filed a Request for Designation of TR987® 0.1% gel as a biologic with the FDA, a move that could enhance its market differentiation by emphasizing immunological activity. The FDA’s preliminary review is expected imminently, with a formal response due by mid-June. Additionally, the company is pursuing a US 510(k) device application for TR Pro+®, potentially opening an alternative commercial pathway for chronic wound and dermatology indications.

Manufacturing scale-up is progressing with the extraction of the proprietary Glucoprime® active pharmaceutical ingredient (API). The first of five batches was completed in April, providing sufficient API to support TR Pro+® sales and future TGA-approved product launches. Discussions with contract manufacturers are underway to develop a commercial-scale production process, addressing current limitations in manual handling and volume capacity.

Commercial Momentum for TR Pro+®

Commercially, TR Pro+® continues to gain traction in the aesthetic market. After expected seasonal lows early in the year, sales rebounded to a record high in March, with orders from over 300 clinics. The company is expanding its product line to include larger tube sizes and a premium serum formulation by year-end, responding to validated market demand. Distribution partnerships are being actively pursued in Australia, New Zealand, and the broader Asia Pacific region, supported by a Singapore-based consultant facilitating introductions.

Financial Position and Outlook

Financially, Tissue Repair ended the quarter with $12.6 million in cash. Operating cash outflows of approximately $1.8 million were primarily directed towards clinical trials and product development. The company also anticipates receiving an R&D tax incentive refund within six months, which will bolster its cash position. While the company’s use of funds shows some variances against its original prospectus allocations, management considers these consistent with the operational needs of a biotech firm at this stage.

Looking ahead, Tissue Repair plans to accelerate patient enrollment, complete additional API batches, advance regulatory filings, and secure distribution agreements. These milestones will be critical to sustaining momentum amid a challenging US wound care landscape reshaped by regulatory scrutiny and heightened clinical evidence requirements.