AMSTERDAM, THE NETHERLANDS, 03 June 2024. SERDA Therapeutics, a biopharmaceutical company focused on developing improved treatments for burns and chronic wounds, today announced initiation of its first Phase 1 human clinical study of SN514 hydrogel, an innovative enzymatic wound debriding agent, in healthy adult volunteers.
SN514 hydrogel is a topical debridement product designed to remove eschar rapidly and effectively from severe burn wounds and chronic ulcers, including pressure injury ulcers, venous leg ulcers (open leg) and diabetic foot ulcers. It is the first clinical development in many years of an innovative enzymatic debriding agent with exceptional long-term stability with the potential of becoming a product of first choice in wound care.
In preclinical studies, SN514 hydrogel showed outstanding efficacy and speed of action with both in vitro substrates and in vivo wound models, a high degree of stability within its formulation, and ease of use. Application of the hydrogel will not require a surgery room or anaesthesia, unlike several other debriding products and methods.
Healing of severe wounds and ulcers is very often hampered by the formation of slough and eschar, which inhibit and interfere with the healing process. Removal of slough and eschar also has the potential to reduce the likelihood of local wound infection.
SN514 hydrogel is easy to apply. It does not require expert medical professionals and can be self-administered or applied by caregivers. As a result, SN514 hydrogel is expected to reduce the cost-of-care associated with severe burn wounds and chronic ulcers.
“We are delighted to announce this clinical trial for the evaluation of the safety and tolerability of SN514 hydrogel,” said Gábor Heltovics, CEO of SERDA Therapeutics. ” The initiation of this clinical study is a critical step toward establishing evidence for SN514 hydrogel as best-in-class to remove eschar rapidly and effectively from burn wounds and chronic ulcers.”
“This study is an important first step in the clinical development of SN514, providing meaningful information for design of subsequent dose ranging and efficacy trials”, said Dr. Bert Slade, CMO of SERDA Therapeutics. “We are thrilled to be underway with the clinical phase of testing and look forward to presenting data at the end of 2024”.
PHASE 1 STUDY DESIGN
The objective of this phase 1 study is to evaluate the tolerability and cumulative irritation potential of SN514 when applied daily for 21 Days to the skin of healthy adult volunteers. The study is being conducted in Irving, Texas, US, by RCTS (Reliance Clinical Testing Services), a part of ALS Limited.
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. Traditional debridement methods—surgical, mechanical, and enzymatic—are often painful and inefficient. 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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