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Braintale to Showcase Data on Exploratory Sub-study of Minoryx’s Pivotal ADVANCE Phase 2/3 Study at 33rd ENRS Conference

Braintale, an innovative company dedicated to neurological disorders and management of brain injured patients with its portfolio of solutions in neurology and intensive care today announced a poster showcasing data from the exploratory sub-study of Minoryx’s ADVANCE phase 2/3 clinical study on clinical benefits of leriglitazone in adrenomyeloneuropathy (AMN) presented at the 33rd Annual meeting of the Eastern Neuroradiology Society, held virtually on August 19 – 22nd, 2021.

The poster entitled “Diffusion brain markers for myelin content follow up: relevance, correlation and potential for Adrenomyeloneuropathy follow up” is based on a first approach to measure clinical evolution and to assess progression of microstructural alterations as measured by brainQuant biomarkers in response to leriglitazone in the Pitié-Salpêtrière hospital patient cohort (n=21) including both active and placebo arms (randomization 1:3) from Minoryx’s pivotal ADVANCE phase 2/3 study.

The objective was to evaluate disease progression or regression in AMN with standardized regional diffusion biomarkers developed by Braintale. The analysis showed excellent correlation between clinical evaluation (EDSS and SSPROM) and biomarkers follow up over the study duration. Secondly, brainQuant biomarkers showed significant difference between active and placebo groups of patients from baseline to year 1 (p<0.05). It enables visualization of active drug positive effect on progression of myelin alterations within cerebral white matter discriminating, after blind analysis, between active and placebo patient’s population.

This data strengthens the potential of brainQuant biomarkers for efficient myelin-related disease monitoring and patient stratification while showing leriglitazone’s impact on the progression of the disease.

About X-ALD and AMN

X-ALD (X-linked adrenoleukodystrophy) is an orphan neurodegenerative disease. The global incidence of X-ALD is approximately 6.2/100,000 live births and AMN and cALD are the two most common phenotypes. AMN affects all patients reaching adulthood and is characterized by progressive spastic paraparesis, sensory dysfunction and incontinence. This form progresses chronically with onset of symptoms typically in adulthood, affecting both men and women and has poor prognosis. There is currently no approved treatment available for AMN where the only available treatment for cALD is hematopoietic stem cell transplantation (HSCT), a very aggressive procedure with no evidence of long-term effects.

About Braintale

Braintale is an innovative company opening a new era in medicine by providing physicians with clinically validated prognostic solutions for the management of brain injured patients through sensitive and reliable measurements of brain white-matter microstructure alterations. Building on more than 15 years in clinical development, Braintale’s products are developed collaboratively to address medical need and fulfill expectations of healthcare professionals and patients alike.

Since its inception in 2018, the company has set up a complete quality management system and is now ISO :13485 :2016 certified, with a suite of products available on the European market.

For more information, please visit www.braintale.fr

About ENRS

The ENRS 33rd Annual Meeting is targeted to practicing academic and private practice radiologists, residents, fellows, scientists, and other health professionals whose practice involves neuroradiology, neurointervention, otolaryngology, neurosurgery, neurology, and imaging science. The ENRS is well known for its first-class educational content delivered in a diverse, congenial, and inviting atmosphere that mentors and sponsors new faculty

https://enrs.edusymp.com/product/details/838

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