AMSTERDAM, The NETHERLANDS, July 4th, 2025 — SERDA Therapeutics, a joint venture dedicated to the development of SN514 (a thermolysin enzyme) for debridement of burns and chronic cutaneous wounds, today announced that the first patient was enrolled into a Department of Defense funded Phase 1 tolerability study at the U.S. Army Institute of Surgical Research Burn Unit located at Fort Sam Houston in San Antonio, Texas (NCT06628037). Together with the Metis Foundation of San Antonio, SERDA is examining a range of concentrations of SN514 in the 066b hydrogel formulation, which allows the investigational product to be easily and conveniently applied without further preparation. Based on the findings of a completed Phase 1 irritation study (PMID: 39853227), no protection of healthy periwound skin is used in this study. Initial clinical data from this trial is expected in the first half of 2026.
SN514 differs from other enzymatic debriders currently on the market. It is a single enzyme with broad substrate specificity, rapid kinetics, and exceptional thermal stability on storage in the hydrogel formulation. SN514 holds the promise of being both rapid and well tolerated, but no data are yet available on open human wounds.
Bert Slade MD, serving as Chief Medical Officer for SERDA, said “We are thrilled to initiate enrollment into this first open wound study, after many years of promising nonclinical studies in porcine burn wound models including at the Institute for Surgical Research.”
Gabor Heltovics, SERDA’s CEO, stated “This is an important milestone for our development program, as the data acquired in this study will allow us to select doses for Phase 2 efficacy studies both in burn wounds and chronic cutaneous wounds such as pressure injuries. The design of the study allows us to have a glimpse at the efficacy potential of this exciting investigational product.”
Enzymatic Debridement Opportunity
The global debridement market that includes indications such as burns, pressure injuries, venous leg ulcers and diabetic foot ulcers is growing at 6.1% CAGR and is expected to reach € 6.5 billion in 2029 . Each indication will require a dedicated set of clinical studies to support an application for marketing. The drug concentration and frequency of application may differ among these potential indications, while the mechanism of action remains fundamentally the same. Additional aspects of potential benefit which can be explored include time to healing, durability of healing, and characteristics of scarring. The stability and simplicity of this “ready to use” formulation make it an ideal potential candidate in preparedness for possible mass casualty events.
About SERDA Therapeutics
SERDA Therapeutics is a leader in developing innovative treatments for severe wound care. With an aging population and increasing diabetes prevalence, effective wound treatment is critical. SERDA’s solution is a hydrogel which offers an enzymatic wound debrider that has the potential to show fast speed of debridement, ease of use, high level of stability, and low-moderate irritation.
The terms “SERDA” and “SERDA therapeutics” are used to refer to SERDA bv.
For more information about SERDA therapeutics, please visit www.serda-therapeutics.com.
Forward-looking Statements
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