Oneness Biotech Co Ltd (合一生技) yesterday said that preliminary third-phase clinical trials of a new drug called ON101, used to treat chronic diabetic foot ulcers, have been successful in improving wound healing.
The study showed that 60.3 percent of patients in the ON101 group had made a full recovery from their wounds, a 25.9 percentage point improvement compared with the 34.4 percent in the group treated with Aquacel Ag hydrocolloid dressings made by UK-based ConvaTec Inc, Oneness said in a filing with the Taiwan Stock Exchange.
The study, which was conducted on 236 patients divided equally into two groups, showed a statistically significant p-value of 0.004 in its full analysis set, the filing said.
The full analysis set includes all patients who have participated in the study.
In the modified intention-to-treat set, ON101 demonstrated a 62.7 percent wound recovery rate, compared with the 23.3 percent of the Aquacel group, while the p-value was gauged at less than 0.001, the company added.
The modified intention-to-treat set allows for the exclusion of some randomized subjects, such as patients who were deemed ineligible based on the prior condition of their wounds or patients who never started treatment, the company said.
Among patients with foot ulcers and wounds larger than 5cm2, ON101 demonstrated a healing rate of 63.6 percent and 57.1 percent respectively, which was 40.3 percent and 51.2 percent greater than the control group.
The company said that the study is still ongoing, and that the results may change after the data set is locked and analyzed.
An application is expected to be filed with the Food and Drug Administration once the study is completed, the company said, adding that other studies are planned for the European and Chinese markets to test the drug’s effectiveness on a variety of ethnic groups.
ON101 is an ointment containing extracts commonly used traditional Chinese medicinal herbs, Plectranthus amboinicus and Centella asiatica urban, the company said.
The drug mainly reduces inflammation, facilitates epithelialization of epidermal tissues, promotes production of collagen and minimizes granulation tissue formation.
It is designed to reduce ulcerations among diabetic patients with a higher risk of chronic infection due to diminished blood supply to the wound site.
Trading of Oneness shares was suspended yesterday as per regulations, as the company disclosed material information. The shares closed at NT$34.85 on Friday last week.
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