[by Lee, Young Sung] GI Biome, an affiliate of GI Innovation, announced on May 8 that it has received approval from the Ministry of Food and Drug Safety for the Phase 2a clinical trial (IND) of its microbiome-based therapeutic candidate, ‘GB-X01.’
인터넷 바카라 is a microbiome-based novel drug candidate consisting of a single live strain discovered through GI Biome’s proprietary GI-SCOVERY platform.
The company noted that preliminary non-clinical efficacy evaluations demonstrated that the strain exhibits anti-tumor effects and strengthens barrier function in intestinal damage models.
Based on these findings, the Phase 1 clinical 인터넷 바카라 for GB-X01 was conducted in patients who had undergone colorectal cancer surgery, with the recommended Phase 2a dose (RP2D) determined through various exploratory assessments, including safety, tolerability, intestinal microbiota modulation analysis, and improvement in symptoms of Lower Anterior Resection Syndrome (LARS).
The target indication for this domestic Phase 2a clinical 인터넷 바카라 is Lower Anterior Resection Syndrome (LARS). In the previous Phase 1 인터넷 바카라, GB-X01 demonstrated significant symptom improvement in patients with LARS, particularly in the high-dose group.
인터넷 바카라 is a known postoperative complication that significantly reduces quality of life for colorectal cancer patients, characterized by symptoms such as control bowel difficulties. Despite its impact, there are currently no effective treatments for 인터넷 바카라, making it a critical area of unmet medical need.
GB-X01 is expected to improve symptoms through its mechanism of action, which changes the intestinal environment and strengthens intestinal function. The Phase 2a clinical 인터넷 바카라 will be led by Professor Lee Woo-yong, the director of the Cancer Hospital at Samsung Medical Center, who also oversaw the Phase 1 clinical 인터넷 바카라.
In addition to the GB-X01 clinical 인터넷 바카라, GI Biome is also rapidly advancing human application studies for health functional foods, aiming for individual recognition as a functional raw material for reducing body fat. The company has identified a strain that promotes GLP-1 hormone secretion and has demonstrated efficacy in improving neutral fat levels, which has been registered as a proprietary patented strain. This 인터넷 바카라 has already recruited 30 participants and is being led by Professor Kang Jae-heon, an obesity specialist at Kangbuk Samsung Hospital.
“GB-X01 showed excellent efficacy in the LARS Score (disease score) during the Phase 1 clinical 인터넷 바카라s. With this Phase 2a IND approval, we are committed to advancing the commercialization of this microbiome-based novel drug, aiming for conditional approval for LARS,” said Yang Bo-gie, CEO of GI Biome. “We will also expedite the development of our anti-aging pipeline,” she added.
On the other hand, GI Biome is preparing for a KOSDAQ listing in the second half of 2026 and is prioritizing the development of anti-aging products, having recently completed the Microbiome Number Seven clinical 인터넷 바카라 for elderly patients at Seoul National University College of Medicine.