Zhijun Biotech's FMT Drug XBI-302 Receives FDA Clearance to Enter Phase II Clinical Trials

Recently, Xbiome announced that its FMT drug, coded XBI-302, received feedback from the U.S. FDA on the EOP1 application.Can officially enter the Phase II clinical trial stage for the treatment of acute Graft-versus-Host Disease (aGvHD).

Public information shows that each pipeline progress of XBI-302 has created a milestone in China's microecological pharmaceuticals field. According to public information from Informa Pharma Intelligence, in 2021, XBI-302 became the first FMT drug developed by a Chinese microecological pharmaceutical company to obtain its clinical approval; this time, XBI-302's approval to enter phase II clinical trials has once again become an industry event of the year.

Dr. Tan Yan, Co-founder and CEO of Xbiome, stated, "The approval of XBI-302 marks a significant pipeline advancement for Xbiome and propels China's microbiome pharmaceuticals forward once again."From 2022 to 2023, two FMT drugs have been approved for marketing globally, verifying the drug development and market entry pathway for fecal microbiota transplantation. XBI-302 is aimed at acute graft-versus-host disease, which has an urgent clinical need.Xbiome will continue to advance the rapid development and submission of this pipeline, with the expectation of bringing clinical benefits to patients as soon as possible."

XBI-302 is primarily indicated for acute graft-versus-host disease (GvHD) involving the gastrointestinal tract, a major subtype of GvHD. This condition is a common complication following allogeneic hematopoietic stem cell transplantation, where the donor's immune cells attack the recipient's organs, resulting in a clinical and pathological syndrome.

XBI-302 replaces the damaged intestinal flora in patients with healthy flora, helping the body rebuild the immune system without affecting the treatment of graft-versus-host disease, ultimately reducing disease recurrence and improving recovery.

FMT treatment is usually complex in operation, and the bacterial solution is not easy to preserve. XBI-302, based on a microbiome drug production system established during the U.S. registration and application process, has gained recognition from the U.S. FDA in terms of production processes, technology, and quality standards. It preserves the live bacterial components in capsule form, addressing the shortcomings of traditional treatment methods in transportation and timeliness.

The Phase I clinical trial of XBI-302 is a two-part, randomized, placebo-controlled, double-blind, single-center study designed to evaluate the safety and tolerability of XBI-302 administered orally in healthy volunteers. A total of 36 healthy subjects were enrolled, and the results showed that XBI-302 was safe and well-tolerated at both single and multiple ascending doses.

It is reported that, with the differences in donors and their provided intestinal flora, FMT drugs are expected to treat a wider variety of diseases.Next, while accelerating the clinical trial process of XBI-302, Xbiome will further explore the therapeutic potential of FMT (fecal microbiota transplantation) in other indications by leveraging its AI microbiome research and industrial transformation platform.

While filing for drug registration, Xbiome is also actively advancing the medical technology transformation of FMT (fecal microbiota transplantation) in China. By collaborating with hospitals and health institutions, they provide FMT solutions that can effectively intervene in various chronic diseases and sub-health symptoms, bringing the benefits of cutting-edge science and technology to a wider population.

Xbiome, supported by FMT management tools and complementary products, provides an overall solution spanning the entire FMT transplantation cycle. The solution offers a "comprehensive eight-in-one service matrix," including FMT product development, testing and analysis services, post-transplantation microbiota maintenance products, customized microbiome solutions, construction of microbiota resource libraries, technical support and training, data analysis services, and consulting services. It is committed to providing high-quality FMT customization services and technical support to medical institutions and health centers at all levels across China.

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