SERDA therapeutics, a biopharmaceutical company, announces that it has submitted an Investigational New Drug Application (IND) to the US FDA on the 17th February, 2023 for its lead product SN514 hydrogel, an innovative enzymatic wound debriding agent. Clinical studies are expected to start in Q2 2023.
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 will be the first clinical development in many years of an innovative enzymatic debriding agent with the potential of becoming a product of first choice in wound care.
In preclinical studies, SN514 hydrogel showed superior efficacy and speed of action over the current market leader and showed much better tolerability and ease of use than other debriding products. Application of the hydrogel will not require a surgery room or anesthesia, as is required for 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 very excited about this IND submission to initiate the clinical development of the SN514 hydrogel - a novel and promising debridement product for the treatment of severe burns and chronic wounds,” says Lucio van Rooijen, CEO of SERDA therapeutics.
About SERDA therapeutics
SERDA therapeutics is a biopharmaceutical company founded in 2020 as a spin-off from one of the leading wound care companies, Smith & Nephew, with NLC, the European Healthtech Venture Builder.
The name SERDA originated as an acronym of Stable Enzymatic Rapid Debridement Agent. Smith & Nephew granted an exclusive license to its preclinically developed product to SERDA therapeutics. SERDA is developing a proprietary best-in-class fast and effective therapeutic product for wound debridement in treatment of severe burn injuries and chronic ulcers, like pressure injuries, venous leg ulcers and diabetic foot ulcers.
SERDA has also received significant financial grant support from the US Army for the performance of a Phase 1 Clinical Trial Utilizing SN514 for Enzymatic Debridement of Burns.
SERDA therapeutics is currently in the process of raising Series A funding.
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
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