Further Validation of IXICO’s AI Imaging Platform

Sets new standards of analysis in neurological disease and presents additional future revenue opportunities

12 February 2025 - London, UK. IXICO plc (AIM: IXI, "IXICO" or "the Company") a global leader in neuroscience imaging, using its AI-driven platform to help advance drug development in neurological disorders, today announces, the generation of further evidence verifying the superiority of the 'IXIQ.Ai' analysis platform in the development and validation of imaging biomarkers for Huntington's Disease (HD), in conjunction with the Huntington's Disease Imaging Harmonisation ("HD-IH") consortium.

HD-IH has passed a significant milestone in HD research by successfully completing the analysis of over 6,000 MRI datasets within the HD-IH framework; the largest image HD dataset of its kind. Using the HD-IH data, IXICO has generated updated HD-Integrated Staging System (HD-ISS) 'cut off values', used to guide disease diagnosis, severity and treatment, in the caudate and putamen areas of the brain.

Applying a proprietary deep learning regional segmentation algorithm IXIQ.Ai was able to establish high quality brain measurements to characterise volumetric changes across the HD-ISS Stages, providing deeper insights into the progression of HD. Additionally, IXICO is working, in collaboration with Key Opinion Leaders, to provide further evidence for the use of brain volume changes measured with IXIQ.Ai as an alternative trial endpoint to traditional clinical outcomes (surrogate endpoint).

The validation advances HD understanding, provides enhanced tools for imaging biomarkers to the biopharma industry and, further evidences the beneficial use of IXIQ.Ai in neurodegenerative disease clinical trials. Such progress has enabled IXICO to expand its clinical trial biomarker analysis offering and presents future revenue opportunities, both within the HD-IH consortium and with additional commercial biopharma partners.

Robin Wolz, Chief Scientific Officer, IXICO, commented: "HD-ISS provides an evidence based biomarker-based framework for the biological definition of HD. The completion of HD-ISS staging cut-off points is an important achievement in the HD-IH consortium. The relevant brain volume measures in a highly accurate and automated tool like IXIQ.Ai allows reliable and robust implementation of the staging system in HD clinical trials. With this major milestone, we will focus with our partners to put those measures into clinical trial use and build further evidence towards the use of brain volumetric measures as surrogate endpoints."

Cristina Sampaio, Chief Medical Officer, CHDI Management, Inc., commented, "It's exciting to see the HD-IH consortium reach this critical milestone in the imaging harmonization plan. The HD-ISS caudate and putamen volume cut-offs are specific for each analytical software platform, and seeing these values become available for the IXIQ.Ai platform is a huge step toward facilitating the generalization of the HD-ISS in defining clinical trial populations."

About HD-IH

The Huntington's Disease Imaging Harmonisation ("HD-IH") consortium is a collaborative initiative focused on harmonising imaging analyses to better understand structural brain changes in Huntington's disease. By leveraging advanced imaging techniques and AI-driven analysis, HD-IH aims to accelerate the development of effective treatments for HD.

HD-IH is a partnership between IXICO, the CHDI Foundation, uniQure, PTC Therapeutics, Asklepios BioPharmaceutical, and newest member Wave Life Sciences, who joined in July 2024. Over the past year, the expanding partnership has made significant progress in applying IXIQ.Ai to more than 6,000 MRI scans available to the consortium and generating the data required to demonstrate the utility of biomarker measurements as clinical trial endpoints.

About IXIQ.Ai

IXIQ.Ai is a proprietary neuroimaging technology developed by IXICO for brain region analysis using AI to measure brain segmentation. The technology provides IXICO research scientists with an agile way to efficiently and rapidly deploy imaging analysis solutions and support clinical decision making for its partners, including critical insights into patient eligibility and drug efficacy.