Xbiome announced that its Phase 2 study with AUP-16 (AUP1602-C) in diabetic foot ulcer has officially obtained IND approval from the National Medical Products Administration (NMPA) and the study can be initiated in China.
Public information shows that AUP1602-C is the first genetically engineered bacterial drug product to obtain clinical approval from the NMPA, setting a new milestone for China’s microbial drug research and development.
Diabetic foot ulcers still represent a globally unmet medical need. In China alone, millions of people face the risk of amputation every year due to DFU; the proportion of people with diabetes in China has exceeded 10%, and the medical burden of diabetic foot ulcers is particularly heavy. AUP1602-C has quickly reached approval for this Phase 2 study and is expected to meet the huge, urgent, and unmet clinical needs of patients suffering from DFUs.
Aurealis Therapeutics and Xbiome announced their partnership In January 2022, through which Xbiome acquired exclusive development and commercial rights for all human use to Aurealis clinical stage DFU drug candidate AUP-16 in Mainland China, Hong Kong, Macao, and Taiwan. Xbiome is responsible for all clinical and other development, regulatory submissions, and commercialization of the licensed products in the licensed territory. Aurealis retains full rights to AUP-16 outside of the specified territory and continues to lead the global development of the drug candidate. The companies are actively collaborating on the joint development for DFU and potentially on other selected indications.
“We are extremely happy about our collaboration with Xbiome and reaching the IND approval for this Phase 2 study is a very important milestone. As we expected, this partnership allows to accelerate the development of AUP-16 as a potential new therapy for Diabetic Foot Ulcers and other chronic wound patients.” said Juha Yrjänheikki, Aurealis CEO.
Yan Tan, founder and CEO of Xbiome commented, “It is a pleasure to see AUP1602-C become Xbiome’s first project to enter Phase II clinical trials, marking a new stage for Xbiome. Since its establishment in 2017, through scientific decision-making and efficient R&D, Xbiome has developed comprehensive drug pipelines in China and the United States. The entry of AUP1602-C into Phase II clinical trials in China, is another significant achievement under the Xbiome’s long-term commitment to differentiation innovation and commercialization strategies. We are very happy about our collaboration with Aurealis and are excited about the future developments.”
AUP-16 is a genetically engineered Lactococcus Cremoris, a non-pathogenic, probiotic bacteria, expressing human basic fibroblast growth factor (FGF2, bFGF), interleukin-4 (IL4) and macrophage colony stimulating factor (CSF1, mCSF) – all in one product and accepted as one active pharmaceutical ingredient from regulatory perspective. AUP-16 is topically applied on chronic wounds and covered by wound dressing (e.g. in diabetic foot ulcers, venous leg ulcers and pressure ulcers). In the wound AUP-16 acts as millions of bioreactors producing the therapeutic proteins, which are designed to i) halt chronic inflammation in the wound, ii) induce growth of new blood vessels, and iii) promote granulation tissue formation and skin re-epithelization – all in one product.
About Aurealis Therapeutics
Aurealis Therapeutics AG is a Swiss-Finnish private clinical-stage synthetic biology company focusing on the development of lactic acid bacteria -based GMO cell and gene therapies. The company’s lead clinical asset is AUP-16, the first-in-class four-in-one cell and gene therapy drug for chronic wounds and other inflammatory degenerative diseases. The product is based on proprietary technology involving genetically engineered lactic acid bacteria acting as millions of small immune activating bioreactors in the human tissue and producing multiple human therapeutic proteins into target tissue to effectively and safely re-educate the distorted host immune microenvironment to proper state.
Xbiome is an industry-leading clinical stage AI-based microbiome drug development company headquartered in China. The company is dedicated to tackling unmet medical needs through various modalities of microbiome therapeutics including faecal microbiota transplantation (FMT), live biotherapeutic product (LBP), and small molecule microbiome modulator (SMMM). In June of 2021, Xbiome obtained IND approval in US for its lead program XBI-302, an orally administered FMT therapy for graft-versus-host disease (GvHD). Currently, Xbiome has 4 clinical stage drug pipelines in China and United States.
For more information:
Laurent Décory, COO
Zongwen Ban, Senior Director, Head of Regulatory Affairs & Clinical