[New Drug Information] The results of the Phase 3 clinical study of ON101, a new drug for the treatment of "diabetic foot ulcer", are announced

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ON101, a drug for the treatment of diabetic foot ulcers with macrophage regulation, has shown a more effective therapeutic effect than absorbent dressings in phase 3 clinical trials
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The product obtained fast track certification from the US FDA in March this year, and was launched in Taiwan Province of China on July 4, 2021
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The main components of ON101 are derived from plants.
ON101 is composed of extracts of two plants [Dendrobium (Plectranthus amboinicus) and Centella asiatica], one of which can inhibit inflammation, and the other can increase collagen synthesis
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The drug exerts a wound healing effect by regulating the balance between M1 and M2 macrophages
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Previous studies have found that hyperglycemia can increase the ratio of M1 pro-inflammatory macrophages to M2 pro-regenerative macrophages.
Some scholars believe that this may be a potential therapeutic target
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In preclinical studies, the above two plant extracts have a synergistic effect on balancing the ratio of M1/M2 macrophages in a mouse model and accelerating wound healing
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Good efficacy and safety results were obtained in two subsequent studies
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Phase 3 study: ON101 treatment effect is significantly better than standard care researchers recruited patients in 21 centers in three countries/regions, requiring age 20-80 years, A1c<12%, Wagner grade 1 or 2, after debridement The area is 1-25cm^2, and the standard care should be received for at least 4 weeks
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The average age of the final enrolled patients was 57 years old, 74% were males, and the average HbA1c8.
1%.
61% had diabetes for more than 10 years.
The majority (78%) of the participants had diabetic foot ulcers graded as Wagner 2 and the average wound area was 4.
8 cm^2, with an average duration of 7 months
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1.
In the end, the treatment effect was 122 people in the ON101 cream group and 114 people in the standard care group, followed up every two weeks
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After 16 weeks of treatment, 74 patients (61%) in the ON101 group and 40 patients (35%) in the standard care group had their wounds healed completely
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In the subgroup analysis, patients with a higher risk of poor wound healing (A1c>9%, ulcer area>5cm^2, diabetic foot ulcer duration>6 months) were also significantly better than standard care when using ON101 cream to heal
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2.
Safety There were 7 cases (5.
7%) of treatment emergency adverse events in the ON101 group, 5 cases (4.
4%) in the standard care group, and no serious adverse events related to treatment in the ON101 group.
The safety of the two groups was similar
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Reference: Huang Y, Lin C, Cheng N, et al.
Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers: A Randomized Clinical Trial.
JAMA Netw Open.
2021;4(9):e2122607 .
doi:10.
1001/jamanetworkopen.
2021.
22607