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Bio B2BOneness Biotech Co., Ltd. 〉ON101- New drug for diabetic foot ulcer healing

ON101- New drug for diabetic foot ulcer healing

ON101- New drug for diabetic foot ulcer healing

First Botanical New Drug for Diabetic Wound Healing. Composed of extracts from Plectranthus amboinicus and Centella asiatica , ON101 reduce wound inflammatory response and promote epidermal growth to facilitate diabetic wounds healing.

Request for Collaboration
Overview
When a wound heals, it usually has three phases, the inflammatory phase, proliferative phase, and remodeling phase. The diabetes patients usually have multiple dysfunctional factors such as growth factors, cytokines, and collagen synthesis and these factors are crucial to wound healing. Furthermore, these patients often develop vascular stenosis or obstruction. As a result, blood supply to the wound site is significantly reduced and it triggers serious infection at the same time. Hence, wound healing is unfavorable and forms ulceration. To care for the wound of diabetes patient, therefore, what matters is not only to prevent wound infection, but also to help repair tissues so that the healing time may be shortened and the risk of chronic wound infection reduced.
The APIs of ON101 is composed of extracts from 2 commonly used traditionally Chinese herbal medicinePlectranthus amboinicus and the Centella asiatica Urban. The dosage form of ON101 is the ointment and it is feasible for patients to use. Animal studies have performed based on ICH guideline and data supports the pharmacologic effects and safety for diabetes patients. It acts mainly to reduce wound inflammation, facilitate epithelialization of epidermal tissues, promote production of collagen, and minimize granulation tissue formation.
For the past few years, 1 academic clinical trial, 1 feasibility clinical study, and Phase 2 clinical trials of ON101 have been completed. All of the clinical trials consistently show favorable efficacy and safety of ON101. Currently, Oneness Biotech is conducting Phase 3 clinical trials (multi-center, randomized controlled study to evaluate the efficacy and safety of ON101 for treatment of chronic diabetic foot ulcers) in more than 10 domestic and international medical centers.
Both animal studies and human clinical trials demonstrate that ON101 is highly safe. The completed Phase 2 clinical trials also show that ON101 is non-inferior or superior to the only diabetic wound healing drug approved by the US FDA. Phase 3 clinical trials of ON101 are ongoing in Taiwan; hopefully ON101 will benefit more patients with diabetic foot ulcers.


Patients’ welfare and safety are the priorities for clinical trials. The clinical trials are conducted under project management and internal auditing for better quality controls.

Application



Patent Portfolio
Plant Extracts For Treating Skin Disorders And Enhancing Healing Of Wounds For Diabetic Patients
Approved: TW, US, EP
Process For The Preparation Of Plant Extracts For Treating Skin Disorders And Enhancing Healing Of Wounds
Approved: TW, US, KR, RU, JP, IN, CN
Collaboration Options
Estimating the number of people with diabetes worldwide and per region in 2015 and 2040 (20-79 years)
More Information
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