The Efficacy and Safety Trial of ENERGI-F703 in Diabetic Wound Healing: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial

Diabetic foot ulcers (DFUs) is a catastrophic ailment that exerts serious medical and psychological impact on diabetic patients. ENERGI-F703 is a hydrogel containing 0.02% adenine as a prodrug for the replenishment of cellular ATP levels to accelerate diabetic wound healing. To demonstrate its efficacy and safety in patients with DFU, 141 patients with type 2 diabetes (T2D) ≥ 20 years old with HbA1c 6.5-12 % and intractable DFUs (Wagner grade 1-3 without active osteomyelitis) were enrolled, randomized 2:1 ENERGI-F703 group (67.4%) to vehicle group (32.6%) for 12 weeks. Most target ulcers were grade 2 (63.6%, N=84) and located mainly on the foot sole (30.3%, N=40) or toe (27.3%, N=36). The primary endpoint was complete ulcer closure rate at the end of treatment. Secondary endpoints included the time required to complete ulcer closure, the accumulated confirmed ulcer closure rate and percentage change in ulcer size at each of the post-treatment visit, and adverse event incidence. Patients with confirmed complete ulcer closure were follow-up for additional 12 weeks and patients with incomplete ulcer closure were additional 4 weeks. An intend-to-treat (ITT) population of 132 subjects and a per-protocol (PP) population of 107 were included in efficacy analyses. Among the PP population with Wagner grade 1 or 2 target ulcers, we observed a significantly higher response rate in the ENERGI-F703 group compared to the vehicle group (48.0% vs. 20.8%, P = 0.0250). Among the ITT population, we also observed a higher response rate in the ENERGI-F703 group compared to the vehicle group (40.3% vs. 20.7%, P = 0.0656). Time to complete target ulcer closure was also faster among patients receiving ENERGI-F703 Gel in both the ITT population (P = 0.0380) and PP population (P = 0.0180). There were no suspected unexpected serious adverse reactions observed throughout the study. Our study showed that ENERGI-F703 Gel is an effective and well-tolerated treatment for DFU. Disclosure G. Young: Employee; Self; Energenesis Biomedical Co., Ltd. J. Lin: Employee; Self; Energenesis Biomedical Co., Ltd. Y. Cheng: Employee; Self; Energenesis Biomedical Co., Ltd. H. Chen: None. C. Huang: Employee; Self; Energenesis Biomedical Co., Ltd.