A novel macrophage-regulating new drug has shown promise in treating diabetic foot ulcers according to the latest issue of article published by the JAMA Network Open

Accumulating scientific evidence has revealed that targeting macrophage phenotypes might be a potentially effective therapy in DFUs because hyperglycemia increases the ratio of proinflammatory M1 to pro-regenerative M2 macrophages. This study is the first international Phase 3 randomized clinical trial of an investigation drug able to regulate M1/M2 macrophage activities in the patients with diabetic foot ulcers (DFUs). The investigational compound has been given a research code: ON101 (trade name: Fespixon) has demonstrated the clinical superiority to the standard care (an absorbent dressing). The primary endpoint, complete healing, was found in 60.7% of the ON101 group and 35.1% of the comparison group during the treatment period (p=0.0001). Time to complete healing, the secondary endpoint, was faster in the ON101 group (p=0.002). The researchers have reported that "Topical application of ON101 with gauze immediately after debridement demonstrated significant healing efficacy compared with an absorbent dressing in all patients, including those with DFU-related risk factors".

The study also demonstrated a good safety profile of study drug. The Treatment-emergent adverse events in the new study occurred in 5.7% of the treatment group and 4.4% of the comparator group (P=0.77); no serious adverse events were reported to be study-drug-related, while osteomyelitis occurred in one patient in the comparator group.

Although current treatments featuring tissue repair or the use of anti-inflammatory agents might help in closing or controlling the progression of DFUs, most of these treatments are not well supported by clinical evidence or are not recommended for routine care by the International Working Group on the Diabetic Foot. In addition, the annual increase in amputations also suggests that treatment improvement is needed.

This topical new drug has been approved by the Taiwan Food and Drug Administration and been granted the fast track designation by the US FDA in March, 2021. It is anticipated that ON101, a macrophage regulator that behaves differently from moisture-retaining dressings, can provide an active-healing alternative for home and primary care of patients with chronic DFUs.

The full text is available on the JAMA Network Open website: https://t.co/7XCUMlsjKu

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