Ixico Regulatory News (IXI)

IXICO plc

("IXICO" or the "Company")

Contract win for a Phase 2 Huntington's disease trial worth circa £2.1m

IXICO plc (AIM: IXI), the precision analytics company delivering intelligent insights in neuroscience, announces that it has once again been selected by a leading Global Pharma company to support their ongoing drug development programme in Huntington's disease. HD is a rare, inherited disease that causes the progressive breakdown of nerve cells in the brain affecting movement, mood and thinking abilities, leading to irreversible decline and eventual death.

This new contract announced today is for IXICO to provide a range of services to support the phase II dose finding study to explore safety, biomarkers and efficacy of the investigative drug in over 300 participants with early manifest and prodromal Huntington's disease. As part of this study, IXICO will leverage its proprietary and trusted Trial Tracker platform to enable over 70 imaging centres across sixteen countries to upload anonymised patient MRI scans to IXICO.

This new study will focus on a more targeted patient population than in the previous phase III trial and open-label extension studies, in which the customer chose to stop dosing patients as a result of an independent committee's review of the therapy's potential benefit/risk profile for the study participants. IXICO's five-year partnership with this sponsor in this indication, has been critical in the delivery of vital safety monitoring and efficacy data analysis, enabling the sponsor to develop the new study protocol. The clinical programme now continues with this new trial scheduled to run until end 2024.

During the previous pivotal trials, IXICO deployed radiology services and advanced MRI techniques to enable patient eligibility and safety monitoring and to improve understanding of the pharmacodynamic aspects of the treatment. This understanding is now supporting the design, planning and implementation of further clinical research focussing on a more targeted patient population. In addition, IXICO is developing new methods to respond to the customer's requirements for ever more stringent in-trial patient safety controls.

Having built an extensive portfolio of proprietary imaging data management and analysis technologies for investigation of neurological disorders since its inception in 2004, IXICO continues to develop its extensive portfolio of advanced neuroimaging solutions and services across the entire drug development lifecycle, from Phase I through to commercialisation.

Giulio Cerroni, CEO of IXICO, commented: " We are delighted to continue our partnership with one of the world's leading pharmaceutical companies working in the field of neurodegenerative diseases. We have been working closely with this customer in Huntington's and the broader research community for many years and continue to play a leading role in leveraging our Neuroimaging expertise and advanced analytics capabilities for much needed new therapies for Huntington's disease. This new contract in addition to the recently announced multi-party consortium for the development of improved imaging biomarkers for the early detection and staging of Huntington's disease ('HD'), demonstrates that we continue to build momentum in the adoption of our advanced analytics and safety monitoring solutions in rare neurological diseases"

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About IXICO

IXICO is dedicated to delivering insights in neuroscience to help transform the advancement of investigational therapies for neurological diseases, such as Huntington's, Parkinson's, Alzheimer's disease and Multiple Sclerosis. 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 machine learning AI data analytics, at scale, through its remote access TrialTracker 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 and follow us on Twitter @IXICOnews