Entero Therapeutics to License AI-Powered Clinical Trial Compliance Tech from Data Vault
Key Insights
Entero Therapeutics will license Data Vault's QOLPOM and FotoDigm platforms to enhance clinical trial compliance, particularly for its Phase 3 latiglutenase trial.
The technology employs machine learning and machine vision to improve remote patient monitoring and data collection in clinical trials.
Entero plans to customize the software for gastrointestinal trials and explore commercial applications for other pharma companies.
Entero Therapeutics, a biopharmaceutical company focused on gastrointestinal (GI) diseases, has entered a binding letter of intent to exclusively license Data Vault Holdings (search)' QOLPOM and FotoDigm technology suites. This move aims to enhance clinical trial compliance using advanced remote patient monitoring and machine vision technologies, initially focusing on Entero's planned Phase 3 trial of latiglutenase for celiac disease (search).
Enhancing Clinical Trial Compliance with AI
The licensed technologies, QOLPOM and FotoDigm, leverage machine learning and IoT sensory capabilities to address behavioral problems in remote patient monitoring. FotoDigm, a patented machine vision technology, combines visual data with historical health records metadata to streamline data collection and verification. Entero Therapeutics intends to customize this software, with a focus on Digital Twins and high-performance computing, to improve patient compliance and data accuracy in its clinical trials.
James Sapirstein, chairman and CEO of Entero Therapeutics, stated, "Compliance is a major issue in drug development – it directly impacts the time, cost and success of clinical trials. We believe that the software platform has the potential to improve outcomes for our phase 3 latiglutenase trial in celiac disease (search), along with the other GI therapeutic indications that we are planning to pursue."
Strategic Investment and Commercialization
Under the terms of the letter of intent, Entero Therapeutics will issue convertible preferred stock to Data Vault and single-digit revenue sharing royalties on net sales. The deal is contingent upon Entero securing a strategic investment of at least $500,000, with a target of up to $3 million, to fund the customization and implementation of the technology. Entero Therapeutics will have the exclusive global license to pilot the technology and develop commercial applications for use in clinical trials with third parties in the pharma and biotech sectors.
Technology Background
QOLPOM (Quality of Life and Peace of Mind) was developed to solve critical behavioral problems within the remote patient monitoring space leveraging machine learning and IoT sensory capabilities. FotoDigm is a patented machine vision technology (US patent number 11,437,139 Method and Apparatus for Biometric Data Collection Combing Visual Data with Historical Health Records Metadata) and has been cited by AT&T, Medtronic, Indiana University and Express Scripts amongst others. A second patent (US patent number 12,040,088 issued on Jul 16, 2024) includes foundational and expanded claims and a platform designed to reduce the costs and streamline processes of data collection, verification on a highly scalable and replicable technology for clinical trial data management.
Future Implications
If validated in clinical trials, Entero Therapeutics believes these technologies could have broader commercial applications for other pharmaceutical companies across multiple disease indications. The company's use of the compliance platform would demonstrate the potential effectiveness and commercial scalability for incorporation in new software applications for a wide range of clinical-trial compliance across multiple therapeutic indications.