ON101
INDICATION
Diabetic Foot Ulcers (DFU)
MECHANISM OF ACTION
ON101 is a first-in-class macrophage-regulating new drug for the chronic wounds. It can effectively regulate the immune environment in the DFU (hyperglycemia causes dermatological immunopathy on DM patients) by suppressing M1 φ overexpression and increase M2 φ to transit the inflammation stage to proliferation stage and to resolve DFU chronicity.
CURRENT STATUS
1. Approved by Taiwan FDA.
2. Under NDA review by China NMPA.
3. Fast Track designation granted by US FDA.
4. Complete of Phase 3 MRCT with superior complete healing rate (60.7% vs. 35.1%, p=0.0001). Data robustness was supported by the consistent healing efficacy in the DFU subgroup analysis. The Ph3 data and mechanism of ON101 have been published on JAMA Network Open(JAMA Netw Open. 2021;4(9):e2122607)
EFFICACY
The 1st International MRCT Phase III study in diabetic foot ulcers has shown its superior healing rate of over 60% in 16 weeks. The results have demonstrated ON101’s clinical superiority in complete healing rate to the control group. The subgroup analysis shows that ON101 achieved robust and consistent complete healing performance across subgroups and even in hard-to-heal ones where ON101 has healed more ulcers with statistical significance. The safety profile of ON101 has been good and clean without serious adverse events.
MARKET POTENTIAL
No new drugs for DFU in the past 20 years but the increase of diabetic patients has been dramatic over that period of time.
According to International Diabetes Federation, 6.4% of diabetic patients have an ulcer that can’t be healed. An unhealed ulcer will likely lead to hospitalization or amputation which impact the healthcare system significantly, let alone the decrease in patients’ mobility as well as productivity. An effective new treatment is urgently needed to fulfil DFU market with 6.8% CAGR forecasted to be US$11 bn in 2026 (Reference: Fortune Business Insights).