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The post hoc analysis of the global novel drug, Fespixon (ON101), on hard-to-heal diabetic foot ulcers has been published in Advances in Wound Care |
- Date of occurrence of the event: 2024/09/05
- Company name: ONENESS BIOTECH CO., LTD.
- Relationship to the Company (please enter ”head office” or ”subsidiaries”): head office
- Reciprocal shareholding ratios: NA
- Cause of occurrence: Post hoc analysis of the phase III international multicenter clinical trial of Fespixon (ON101) demonstrated its superior efficacy in promoting healing in hard-to-heal subgroups of diabetic foot ulcer (DFU) compared to the control group with statistical significance. The results have been accepted by the SCI journal Advances in Wound Care for publication.
- Countermeasures: None
- Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.):
- (1) The phase III international multicenter randomized clinical trial of Fespixon (ON101) was conducted on 236 subjects of DFUs and an extension study in China was proceeded with including 40 more subjects from China. The study included a total of 276 subjects. The full analysis set (FAS) data showed that 61.7% of the subjects in the ON101 group and 37.0% of the subjects in the control group (Aquacel) achieved complete wound closure; the difference in the incidence of complete wound closure between the two groups was 24.7%, which was statistically significant (P = 0.0001).
- (2) The healing of superficial DFUs treated by standard of care with good compliance is higher than the hard-to-heal DFUs, such as classified as Wagner grade 2, in the plantar region, with size≧5 cm2, with duration ≧3 months, on patients with poor glycemic control HbA1c≧9%, and on overweight patients with BMI≧25. These groups have poor healing rate and high amputation risk. The post hoc analysis of Fespixon (ON101) for hard-to-heal DFUs in the phase III randomized clinical trial shows statistically significant results.
- (3) Advances in Wound Care (impact factor:5.8) is an international medical journal with an emphasis on acute and chronic wounds, and wound care applications for burns, major trauma, blast injuries, surgery, and diabetic ulcers. This post-hoc analysis is corresponded by Prof. David Armstrong, the global DFU KOL, and Prof. Guang Ning, the Academician of Chinese Academy of Engineering. Fespixon's excellent therapeutic effect in hard-to-heal subgroups has been peer-reviewed and acknowledged. The online publication will increase the understanding of Fespixon’s efficacy by international DFU specialists. The article is available online on Advances in Wound Care: https://www.liebertpub.com/doi/10.1089/wound.2023.0167
- (4) Oneness is committed to advancing scientific research in innovative drugs and medical devices, generating post-marketing clinical evidence, and consistently publishing our findings in internationally renowned journals. This enhances our global recognition and the competitive advantage of our products, establishing a robust foundation for global commercialization.
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