Successful topline Phase 3 data of ON101 new drug
Oneness Biotech held a press conference today to announce the topline Phase 3 data for diabetic foot ulcer new drug ON101. The data has been unblended and primary endpoint has been achieved.
The Phase 3 MRCT compares the efficacy and safety of ON101 with Aquacel Hydrofiber dressing in treatment of diabetic foot ulcers. Aquacel is a medical device in current clinical management of diabetic foot ulcers.
According to the statistical analysis, ON101 achieves statistical significance in primary endpoint and is well-tolerated in safety evaluation.
62.2% of the subjects in ON101 achieved complete healing while only 34.7% of those in Aquacel group did. The healing rate difference is 27.5% and achieves statistical significance.
Translated from Udn News.