GI Biome said on Wednesday that it signed a memorandum of understanding (MOU) with two digital healthcare companies, InHandPlus and GI VITA, to jointly develop a decentralized clinical trial (DCT) platform to accelerate the global market entry of GB-X01, an anticancer microbiome pipeline.
According to the agreement, the three companies plan to introduce medication monitoring systems and personalized medication management services through smart devices into clinical trials to develop optimized DCT platforms.
GI Biome is developing new microbiome drugs for the treatment of cancer, metabolic diseases, and allergic diseases. In particular, its anti-cancer microbiome pipeline GB-X01, which entered phase 1 clinical trials earlier this year, is on track to dose its first patient this month.
In designing the phase 1 trial, the company recognized the importance of managing patient adherence and collaborated with InHandPlus, to help monitor medication compliance through wearable devices.
"Since the Covid-19 pandemic, DCT has been gaining traction in major developed countries as an alternative clinical trial approach,” said GI Biome CEO Kim Young-suk. “Through this MOU, we would like to establish a DCT model that can lead this global trend.”
InHandPlus has AI smartwatch-based medication behavior analysis technology, which enables users to monitor the medications they consume. It automatically collects real-world data on patients' medication remotely and provides personalized medication management services.
"The InHandPlus AI smartwatch can analyze not only medication data, but also daily health records such as activity, heart rate, and sleep status, which are optimized for remote patient monitoring," said InHandPlus CEO Lee Hwi-won. "We hope to create synergies in the global DCT business through cooperation with GI Biome and GI VITA."
Additionally, GI VITA is a digital healthcare platform company that provides healthcare and disease prevention solutions using AI-generated health data and medical expert guidance.
Accordingly, GI VITA will develop a demonstration business model and advance its solutions to help commercialize the DCT model.