BrainTale Announces First Patient Enrolled in Investigator-Sponsored Prospective Multi-Centric Study CALDIFF to Clinically Validate One of Its Predictive Biomarkers

The investigator-sponsored study aims at demonstrating the predictive value of one of BrainTale’s biomarkers in a white matter diseases.
This biomarker aims at enabling early diagnosis and prognostic of the cerebral form of X-linked adrenoleukodystrophy.
With the development and clinical validation of this biomarker, BrainTale would enable the research and development of brand new treatments for patients suffering from white matter diseases and supporting improved patient care.

BrainTale Announces First Patient Enrolled in Investigator-Sponsored Prospective Multi-Centric Study CALDIFF to Clinically Validate One of Its Predictive Biomarkers

BrainTale – Lisa Marcheval, communication manager, lisa.marcheval@braintale.eu

Press relations: Anna Casal, +33650615571, casal.anna@gmail.com

BrainTale, a medtech deciphering white matter to enable better brain care, spin-off of the Paris Region Greater Hospitals, announced today the enrollment of the first patient in the CALDIFF, investigator-sponsored clinical trial, sponsored by the Paris Region Greater Hospitals (Assistance Publique - Hôpitaux de Paris) and led by Professor Fanny Mochel (APHP220801, NCT05911919). The study has been designed to clinically demonstrate the potential of a BrainTale-developed biomarker to predict in the early phase the progression of X-linked cerebral adrenoleukodystrophy (X-ALD).

"There is an urgent need for new methods of early diagnosis in X-ALD to enable faster and more effective therapeutic interventions," declares Prof. Fanny Mochel, Head of the Neurometabolic Diseases and Leukodystrophies Reference Center at the Pitié-Salpêtrière Hospital (AP-HP) and principal investigator. “This biomarker has great potential for improving patient follow-up and detecting signs of the disease to enable appropriate care.”

CALDIFF is an investigator-sponsored prospective multi-centric study planned in 12 centers using the BrainTale platform for analyzing and exploiting diffusion MRI (magnetic resonance imaging) data. It aims at clinically demonstrating the potential of a BrainTale-developed biomarker to predict in the early phase the progression of X-linked cerebral adrenoleukodystrophy, a white matter orphan disease. The results of this study could transform the patient care by supporting the decision and implementation of an allogeneic bone marrow transplant at an early stage of the disease, the only treatment today to halt or even reverse the demyelinating lesions of the disease, thus reducing the associated morbidity and mortality.

“The launch of this trial is a key step in demonstrating the clinical usefulness of this biomarker, which could optimize the care of X-ALD patients,” comments Prof. Damien Galanaud, neuroradiologist (AP-HP), co-founder of BrainTale and scientific leader of the study.

This clinical validation of a biomarker developed on BrainTale's technology platform paves the way for precision neurology. The biomarkers developed by BrainTale support the research and development of new treatments by optimizing clinical trials, in particular by homogenizing patient populations and demonstrating the efficacy of drug candidates through higher sensitivity monitoring of diseases progression. BrainTale aims at accelerating the development of new therapies for patients suffering from X-ALD as well as other white matter diseases such as leukodystrophies and multiple sclerosis.

What is X-linked cerebral adrenoleukodystrophy?
X-linked adrenoleukodystrophy (X-ALD) is a rare and serious genetic disorder, mainly affecting males. With an incidence of 1 per 17,000 births, it is the most common leukodystrophy. This metabolic disease affects the brain, spinal cord and peripheral nerves, as well as the adrenal glands and testes.
X-ALD can appear at different ages and in different clinical forms. It occurs in all populations and ethnic groups with similar frequencies. The true incidence may be underestimated, not least because of the lack of systematic neonatal screening.

About BrainTale

BrainTale is an innovative European medtech company measuring the brain through white matter quantification and standardization based on a commercially available software medical device solution. This regulatory-cleared AI software offers quality controlled, non-invasive, reliable and clinically validated reports after diffusion tensor MRI data processing. BrainTale enables drug developers, leading academic researchers, and physicians to improve patient care by understanding neuroinflammatory and neurodegenerative conditions, assess brain lesions evolutions and take appropriate decisions in the clinic and during drug development. BrainTale empowers the scientific and medical community with objective measure to transform brain care.

Because brain diseases have become the medical issue of our time, we can no longer wait. At BrainTale, we strongly believe that by exploring better, we can treat faster, together.

For more information, please visit www.braintale.eu