IXICO plc

("IXICO" or the "Company")

HD-IH Consortium

IXICO plc (AIM: IXI), the medical imaging advanced analytics company delivering intelligent insights in neuroscience, today provides further information on the HD-IH consortium it announced in its RNS dated 10^th May 2022.  This information is being released on various platforms including the Company's website.

Call to Action - New consortium will use artificial intelligence technology to conduct large-scale analysis of brain changes in Huntington's disease

New York, NY / London, UK, September 21 2022; IXICO, uniQure, PTC Therapeutics, Inc, and CHDI Foundation have formed the Huntington's Disease Imaging Harmonization Consortium (HD-IH) to better understand the structural brain changes that occur over the course of HD. Accurate segmentation of magnetic resonance images (MRIs) is essential to measuring the brain's anatomical structures, and the HD-IH consortium will establish a data repository to enable pharmaceutical and nonprofit members to develop more targeted therapeutic strategies, inform eligibility and dosing decisions, and aid associated trial design and biomarker development.

The HD-IH consortium aims to analyse more than 6,000 participant-visit MRIs that were acquired from over 2,000 participants enrolled in the TRACK-HD, PREDICT-HD, and IMAGE-HD natural history studies. A first of its kind, the plan is to systematically conduct harmonized analysis across all three study cohorts to produce a rich dataset that will give insight into key brain volumetric biomarkers over the course of HD. Using IXICO's artificial intelligence-based IXIQ.Ai analysis platform, HD-IH will build a high-quality data repository using both fully automated segmentation techniques and manual correction steps during quality control to provide more precise volumetric data for analyses.

"The imaging harmonization that this consortium is conducting will be a turning point in the development of volumetric MRI biomarkers to monitor disease progression and response to interventions in Huntington's disease," said Cristina Sampaio, Chief Medical Officer at CHDI. "Groundwork of this sort is foundational for scientific breakthroughs."

In its current phase, scheduled to be completed by the end of 2022, the consortium's founding members are setting up the data analytics infrastructure and completing the analysis of approximately one third of the images.

High quality caudate and putamen volumetric data were recently chosen as landmark variables for entry into Stage 1 of the new Huntington's Disease Integrated Staging System (HD-ISS), when demonstrable neurodegeneration can be detected by changes in these biomarkers. Consequently, the HD-IH consortium members are working together with clinical and scientific HD experts to translate Stage 1 cut-off tables so that the HD-ISS criteria can be readily applied within this imaging analysis platform, thereby enabling robust implementation of the HD-ISS in future clinical trials.

IXICO's Marina Papoutsi presented the aims of the consortium at the recent European Huntington's Disease Network (EHDN) Imaging Working Group meeting on September 15, 2022, which was part of the EHDN Plenary Meeting in Bologna, Italy. Presentation slides can be accessed online: https://bit.ly/3S20l4e

Founding members of the HD-IH consortium are inviting additional members to join and contribute to the ongoing image analysis of the remaining data. New members will have full access to all participant-visit results performed to date and will define priorities for upcoming activities to enable targeted planning for their upcoming HD research and clinical trials. Following an exclusivity period, the consortium is committed to making the full dataset available to the wider scientific community.

Robin Wolz, Chief Scientific Officer at IXICO, commented, "Harmonized analysis across heterogeneous data is a critical requirement to enable more targeted clinical trial design through the inclusion of novel biomarkers. We're excited to support this important project in our endeavour to bring novel imaging biomarkers into clinical trials."  

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About IXICO | Advanced Analytics | Intelligent Insights.

IXICO is dedicated to delivering insights in neuroscience to help transform the advancement of investigational therapies for neurological diseases, such as Huntington's disease, Parkinson's disease and Alzheimer's disease. The Company's purpose is to advance medicine and human health by turning data into clinically meaningful information, providing valuable new insights in neuroscience by supporting pharmaceutical companies across all phases of CNS clinical research. IXICO's goal is to be a leading advocate of artificial intelligence in medical image analysis. 

IXICO has developed and deployed breakthrough data analytics, at scale, through its remote access technology platform, to improve the return on investment in drug development and reduce risk and uncertainty in clinical trials for the Company's pharmaceutical clients.

More information is available on www.IXICO.com