SCIENCE

ON101 (FESPIXON®)

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

Note: The finding on the mechanism of action of ON101 has been published on JID Innovations: https://doi.org/10.1016/j.xjidi.2022.100138

Current Status
  1. Approved by Taiwan FDA
  2. Under NDA review by China NMPA, Singapore HSA, Malaysia NPRA and Philippines FDA
  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).

R&D Progress
Complete
In Progress
Research Code Therapeutic Area Indication Pre-Clinical Phase I Phase II Phase III NDA Market More
  • ON101 (FESPIXON®)
    Dermatology
    Diabetic Foot Ulcer

    ON101 is a first-in-class new drug targeting the subsets of macrophages to promote healing of the chronic wounds. It has been demonstrated with the superior efficacy to the standard care dressing in a Phase 3 MRCT completed in the US, Taiwan, and China. It has been marketed under the trade name Fespixon® in Taiwan since June 2021 and been granted the Fast Track designation by the US FDA in March 2021. Multiple NDA submissions of ON101 to Asian health authorities are underway

Note:
1.China & Southeast Asia: Under NDA submission
2.US: Fast Track Designation granted by US FDA

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