First Patient Enrolled in Randomized Trial of VES-0-D Gel
Successful FDA Pre-IND Meeting Supports Path to an IND Submission Targeted for Q4 2027
Flen Health Pharma NV, a Belgium-based biopharmaceutical company with more than 25 years of experience in wound and skin healing solutions, today announced the outcome of a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) for VES gel, its investigational topical drug candidate that uniquely contains an enzyme system to control inflammation for the treatment of chronic diabetic foot ulcers (DFUs). In parallel, the company has enrolled the first patient in AIM-DFU, a multicenter, randomized controlled trial evaluating VES-0-D Gel compared with standard care in the management of DFUs.
Together, the two milestones advance VES gel through the U.S. regulatory pathway toward an Investigational New Drug (IND) submission, which Flen Health anticipates filing in the fourth quarter of 2027. VES-0-D Gel clinical evaluation will support Flen Health's FDA filing for an IND.
"We are very pleased with the outcome of our pre-IND meeting. The FDA's feedback confirmed alignment with our proposed nonclinical and clinical development plan and gives us a clear path to bring VES gel to patients in the United States," said Julie Kerckhof, U.S. Business Strategy Director for Flen Health Pharma NV. "With the first patient now enrolled in AIM-DFU, we are advancing our clinical program in Europe as we work toward our IND submission."
AIM-DFU is a multicenter, randomized controlled trial designed to enroll 64 adults with DFUs across at least 10 investigational sites in Belgium. Participants are randomized 1:1 to VES-0-D Gel or standard care and treated twice weekly over an eight-week period.
The primary endpoint is percent wound area reduction from baseline at the end of eight weeks. Secondary endpoints include change from baseline in the total score of the Bates-Jensen Wound Assessment Tool (BWAT) and the number and nature of treatment-emergent adverse events.
DFUs are a serious complication of diabetes, affecting up to 25% of people with diabetes in their lifetime and costing the U.S. healthcare system an estimated $13 billion annually. In the U.S. alone, an estimated 1.6 million people develop a DFU each year. DFUs are the leading cause of lower-extremity amputations among people with diabetes, accounting for about 85% of such procedures. Globally, an estimated 589 million adults, or 1 in 9, are living with diabetes, and the prevalence of diabetes continues to rise, increasing the risk of non-healing foot ulcers and further straining healthcare systems. Effective wound repair in DFUs is challenged by disrupted cell communication, impaired inflammatory responses, and a hostile healing environment.
U.S. Regulatory Progress
Flen Health met with the FDA on Sept. 2, 2026, in a Type B pre-IND meeting to review its proposed development program for VES gel. At the meeting, the FDA indicated alignment with the company's proposed nonclinical and clinical development plan. The meeting follows positive written feedback the company received from the FDA earlier this year through the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) program, which addressed its Chemistry, Manufacturing, and Controls (CMC) strategy and nonclinical development plan.
Additional Clinical Development
Flen Health is also preparing to initiate ENLIGHT-DFU, an exploratory first-in-human study of VES-0 Gel designed to examine changes in markers of wound inflammation in patients with DFUs. The study is planned to enroll 18 patients across five sites, with treatment over four weeks. Assessments include wound fluid biomarkers, the wound microbiome, and wound area. Submission to the Belgian authorities is anticipated by the end of 2026.
About VES Gel
VES gel is a first-in-class, patented topical drug that uniquely contains an enzyme system to control inflammation for the treatment of diabetic foot ulcers. It leverages a proprietary recombinant enzyme complex in an alginate ointment to promote wound healing while eliminating bacteria and yeast without the development of resistance. Flen Health is developing VES gel for U.S. registration as a drug product. VES-0-D Gel, the investigational device evaluated in the AIM-DFU trial, is a component of the VES gel platform, studied here against standard care to characterize its performance ahead of controlled evaluation of the product.
About Flen Health Pharma NV
Flen Health Pharma NV is a biopharmaceutical company dedicated to developing innovative therapies for unmet needs in wound care. Founded in 2000 and headquartered in Kontich, Belgium, the company has more than 25 years of experience delivering trusted wound and skin healing solutions across Europe and in more than 40 countries worldwide. Flen Health is now leveraging this expertise to bring its novel therapeutics to the U.S. market. For more information, visit www.flenhealth.com.
Forward-Looking Statements
This press release contains forward-looking statements relating to the development, regulatory review, and potential commercialization of VES gel, including statements regarding the design, enrollment, timing, and anticipated results of the company's clinical studies, the anticipated U.S. regulatory classification and pathway for VES gel, and the timing of a planned IND submission. Feedback received from the FDA through the pre-IND meeting and INTERACT program is preliminary and non-binding, and the FDA's final determination of the regulatory classification and pathway for VES gel may differ from the company's current expectations. VES gel and VES-0-D Gel are investigational and have not been approved by the FDA or any other regulatory authority for any use. Actual results may differ due to various factors. Flen Health Pharma NV assumes no obligation to update these statements to reflect future events or circumstances.
View source version on businesswire.com: https://www.businesswire.com/news/home/20261001892618/en/
Contacts:
Julie Kerckhof
U.S. Business Strategy Director
Flen Health Pharma NV
Julie.Kerckhof@flenhealth.com
Media
Carly Scaduto
carly@carlyscadutoconsulting.com
