New York, NY / London, UK, July, 12th 2023; The Huntington’s Disease Imaging Harmonization (HD-IH) Consortium, founded last year to conduct an unprecedented harmonization analysis of more than 6,000 participant-visit magnetic resonance images (MRIs) acquired from over 2,000 research participants, has now completed the initial phase and secured the necessary funding commitment to complete the project. These analyses are expected to support the development of therapeutic strategies targeting more specific sub-populations, inform eligibility and dosing decisions for clinical trials, and aid in associated trial design decisions and biomarker development to enable interventional studies earlier in the disease course.

“Such structural imaging harmonization is the type of groundwork required to develop reliable biomarkers that may accelerate drug development,” said Cristina Sampaio, MD, PhD, Chief Medical Officer at CHDI. “We are now on the cusp of harmonizing the full set of available images, which could become the basis to apply for regulatory acceptance for structural biomarkers as clinical endpoints in drug trials.”

Asklepios BioPharmaceutical, Inc. (AskBio), the newest member of the consortium, is a wholly owned and independently operated subsidiary of Bayer AG. As a fully integrated gene therapy company dedicated to developing life-saving medicines and potentially changing lives, AskBio maintains a portfolio of clinical programs across a range of central nervous system, neuromuscular, cardiovascular and metabolic diseases, including Huntington’s disease. AskBio is committed to contributing to the advancement of gene therapy as a potential treatment for this devastating disease and is proud to help advance the study of Huntington’s  as an HD-IH member.

"We're very pleased to be part of this consortium and support the development of a high-quality imaging database to facilitate clinical trials in Huntington's disease," said Nathalie Cartier-Lacave, MD, Senior Vice President, Sector Lead of Neurobiology, AskBio.

In addition, the HD-IH Consortium founding members (uniQure, IXICO, PTC Therapeutics, and CHDI Foundation, Inc.) have further committed funds to assure the complete analysis of all >6,000 available images. As well as high-quality volumetric scores, full harmonization of the complete imaging dataset will also provide raw drawings of individual brain structures on an individual research participant basis, enabling methodological studies that build, compare, and improve morphometric pipelines.

The HD-IH Consortium continues to invite additional members to join for immediate and full access to all participant-visit results conducted to date and to future results as additional analyses are completed. Following an exclusivity period, the consortium is committed to making the full dataset available to the wider HD research community.

Analysis of approximately one third of the images have now been completed in the first phase of analysis. Applying IXICO’s artificial intelligence-based IXIQ.Ai analysis platform has enabled the measurement of brain volumetric changes in a consistent way and with an accuracy comparable to gold-standard semi-manual techniques. Initial results of this analysis were presented in a poster by Dr. Marina Papoutsi at the 18^th Huntington’s Disease Therapeutics Conference (HDTC) held in Dubrovnik, Croatia, from 24-27 April 2023 (Link).

"We are pleased to see the progress achieved in the HD-IH consortium over the past year,” said Robin Wolz, PhD, Chief Scientific Officer at IXICO. “Seeing positive results with the data analysed to date and having agreed a path towards analysis of all available data is significant progress in our endeavour to bring novel imaging biomarkers into clinical trials to enable more targeted clinical trial design.” 

Caudate and putamen volumetric measures were recently chosen as landmark variables to define entry into Stage 1 of the new Huntington’s Disease Integrated Staging System (HD-ISS) when demonstrable neurodegeneration can be detected by surpassing cut-off values of these biomarkers. Implementation of the HD-ISS in clinical trials was a key discussion point at HDTC in Dubrovnik and the HD-IH consortium members are working together with HD experts to develop a Stage 1 landmark variable cut-off table that is compatible with IXICO’s methods using the results from the consortium analyses so that the HD-ISS criteria may be implemented more easily in future clinical trials. Results of this initiative will be presented at future HD conferences.


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