SERDA therapeutics submits IND for its lead product, an innovative wound debridement agent 2nd March 2023
SERDA therapeutics, a biopharmaceutical company, announces that it has submitted an Investigational New Drug Application (IND) to the US FDA today 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.