International Wound Journal Publishes Positive Phase 2 Interim Data on Cell-free Amniotic Fluid Injectable Biologic for the Treatment of Venous Leg Ulcers

Yahoo

26-03-2025

Results from Part 1 of a two-part Phase 2 clinical trial demonstrate the efficacy and safety of a novel subcutaneous biologic for chronic venous leg ulcers
RESEARCH TRIANGLE PARK, N.C., March 26, 2025 (GLOBE NEWSWIRE) -- Merakris Therapeutics announced the publication of positive clinical trial results from the first part of its ongoing Phase 2, multicenter trial. This study evaluates its biological drug, MTX-001 (Dermacyte Liquid), a cell-free amniotic fluid (cfAF) for chronic, non-healing venous leg ulcers (VLUs). Interim results from part one of the study published in the International Wound Journal, highlights the investigational new drug's potential as a first-in-class biologic therapy in nine patients completing study treatment with lower extremity venous wounds refractory to healing using standard-of-care-based approaches.
Key Findings:
Wound Duration Prior to Treatment: Prior to injection therapy, the patients' VLUs persisted for a median duration of 7 months despite correcting the underlying venous reflux and standard-of-care interventions.
Pain Reduction: Mean pain scores were significantly reduced by the study end.
Total Wound Closure: 66.7% of patients achieved complete wound closure by the one-month post-trial follow-up.
Wound Area Reduction: The average percent reduction of ulcer area was 83.7% in patients that completed the 12-week treatment duration.
Long-Term Chronic Wounds Treated: The average duration of ulcers before study enrollment was 73 weeks, emphasizing the challenge of treating these cases with standard care alone.
'These results are highly encouraging, particularly given the long-standing, non-healing nature of the wounds treated in this study and support the growing body of evidence demonstrating efficacy and safety of this novel subcutaneous biologic for chronic venous leg ulcers,' said Chris Broderick, Merakris' CEO. 'MTX-001 represents an innovative therapeutic approach to significantly improving outcomes for patients suffering from chronic, recalcitrant venous leg ulcers, and if approved, could be a cost-effective therapy.'
Addressing a Critical Unmet Need in Venous Wound Care
Chronic venous insufficiency (CVI) affects millions of Americans, with up to 3% of adults in the United States developing severe venous leg ulcers (VLUs). While 60% of VLUs typically heal within 12 weeks, recurrence rates remain alarmingly high — 30% within one year and up to 70% within two years.
Advancing Innovation in Wound Healing
The primary objectives of the first part of this ongoing Phase 2 trial were to evaluate the safety and tolerability of MTX-001 while gaining insights into dosing frequency and efficacy metrics such as:
Complete wound closure
Reduction of wound size
Pain relief (VAS score)
Improved quality of life (HR-QoL)
'To our knowledge, this is the first multi-patient clinical trial evaluating cfAF therapy for chronic, non-healing VLUs,' added Chris Broderick. 'The data suggest that MTX-001 is safe, well-tolerated, and effective in patients who have undergone correction of underlying venous reflux disease. These findings support its potential role in reducing clinical burden, improving healing rates, and enhancing patient quality of life.'
Next Steps: Enrollment Open for Phase 2 Part 2
Merakris has opened patient enrollment for Part 2 of this Phase 2 clinical trial (NCT04647240) to further assess the efficacy and safety of MTX-001.
For more information on the venous leg ulcer study or Merakris' expanded access drug program, please contact the medical affairs team at [e-mail].
About Merakris Therapeutics
Merakris Therapeutics is a leading innovator in regenerative medicine focused on developing and commercializing biologically derived products for wound healing and other complex conditions. Leveraging advanced biologic manufacturing capabilities and a robust research pipeline, Merakris is committed to improving patient outcomes and advancing the science of regenerative therapies.
Merakris Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris' products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Merakris' management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole. Investigational drug tradename (Dermacyte Liquid or Dermacyte Amniotic Wound Care Liquid) has not been approved by FDA.
PR Contact:Garth MillerNova Marketing [e-mail]919-923-3505