AMSTERDAM, THE NETHERLANDS, 29 July 2024. SERDA Therapeutics, a biopharmaceutical company focused on developing improved treatments for burns and chronic wounds, today announced completion of its first Phase 1 human clinical study of SN514 hydrogel, an innovative enzymatic wound debriding agent, in healthy adult volunteers.
In preclinical studies, SN514 hydrogel showed outstanding efficacy and speed of action both with in vitro substrates and in vivo pig wound models. The first clinical safety question to be addressed was whether healthy skin at the edge of a wound (“periwound skin”) would require any type of protection against the enzyme when applied to the wound surface. The evaluator blinded, randomized study examined the immediate and 21-day cumulative irritation potential of a range of enzyme concentrations formulated into the proprietary hydrogel for off-the-shelf use, as well as the hydrogel vehicle itself. The use of a low irritant control and a positive irritant control allowed calculation of total scores for dermal responses and other effects according to the methodology of Berger and Bowman (Berger and Bowman 1982).
The findings indicate that protection of “periwound” skin is unlikely to be necessary in clinical use. The company plans to present detailed results in December 2024 at the Innovations in Wound Healing Conference in Islamorada, Florida.
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 extremely pleased with the results of this first study, as it really sets the product apart from other enzyme debriders”, said Gábor Heltovics, CEO of SERDA Therapeutics. “We remain confident that SN514 hydrogel will be best-in-class for safe and effective debridement of burn wounds and chronic ulcers.”
“These encouraging findings confirm the design of our next planned Phase 1 study, a dose-ranging tolerability trial in deep partial thickness burn wounds”, said Dr. Bert Slade, CMO of SERDA Therapeutics.
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
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For SERDA, these factors include: risks related to government actions and other restrictive measures taken in response, reduced procedure capacity at medical facilities, or our ability to execute business continuity plans, economic and financial conditions in the markets, especially those affecting health care providers, price levels for pharmaceutical products, developments in therapeutic standard, regulatory approvals, reimbursement decisions or other government actions, product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers, competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organization to adapt to market developments, and numerous other matters that affect us or our markets, including those of a regulatory, political, economic, business, competitive or reputational nature. Any forward-looking statement is based on information available to SERDA as of the date of the statement. All written or oral forward-looking statements attributable to SERDA are qualified by this caution. SERDA does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in SERDA’s expectations.
Berger, R.S., and J.P. Bowman. 1982. ‘A reappraisal of the 21-day cumulative irritation test in man’, J Toxicol – Cut & Ocular Toxicol, 1: 109-15.