Strasbourg, April 25th 2022

BrainTale, a medtech that is deciphering white matter, spin off from the Assistance Publique-Hôpitaux de Paris, showcases, with Minoryx, a biotechnology company developing a treatment for X-linked Adrenoleukodystrophy (X-ALD), the results of the multicentric ADVANCE sub study with Braintale biomarker platform on the occasion of the American Academy of Neurology (AAN). The data were presented digitally on April 24th, 2022. This has also been the occasion to deepen the collaboration between the two companies.

Long underestimated in neurosciences, white matter, which represents 80% of the human brain, plays a key role in its proper functioning, development, and aging, whether normal or pathological. Accordingly, Braintale has been developing, since its inception in 2018, non-invasive, accessible, effective and clinically validated measurement and prediction tools for physicians treating patients suffering from brain diseases.

The BrainTale platform includes AI-processed CE-marked digital solutions, deployed across three modules. BrainQuant enables white matter quantification, brainScore powers clinical prediction and MyelinDex, monitors myelin integrity. Beyond demyelinating conditions, the platform has also been successfully implemented to monitor patients with amyotrophic lateral sclerosis (ALS) and predict recovery for comatose patients after cardiac arrest or trauma brain injury.

X-ALD is an inherited orphan neurodegenerative disease. The most common form is adrenomyeloneuropathy (AMN), which is a highly debilitating chronic disease affecting male and female X-ALD patients reaching adulthood. There is currently no approved treatment for AMN patients. X-ALD male patients can also develop the acute cerebral form, cALD, in both pediatric age and adulthood. cALD results in aggressive brain inflammation leading to permanent disability and death within 2-4 years.

Leriglitazone, a novel brain penetrant PPAR gamma agonist, recently showed significant clinical benefit in Minoryx’s ADVANCE Phase II/III clinical trial in adult male patients with AMN. A separate phase II/III study in male pediatric patients with early stage cALD is ongoing (NEXUS).

On the occasion of the American Academy of Neurology, Braintale and Minoryx jointly presented additional results of a multicenter sub-study from the ADVANCE trial. The abstract is available online: https://index.mirasmart.com/aan2022/PDFfiles/AAN2022-002872.html
Beyond the characterization of MyelinDex as a relevant biomarker for monitoring disease progression and therapeutic efficacy, these data further support the efficacy of leriglitazone and its potential to improve myelin integrity in the brain of patients affected by AMN. These results pave the way to use of MyelinDex for disease and treatment monitoring in clinical trials as well as patient management in a hospital setting.

The collaboration between the two companies has expanded in order, notably, to implement the use of MyelinDex in additional clinical trials to further characterize beneficial impact of leriglitazone on myelin content, while contributing to a better understanding of X-ALD.

“We are very excited to see the potential of Braintale’s technology to deliver precise and longitudinal analysis of white matter” said Marc Martinell, CEO of Minoryx Therapeutics. “These results are aligned with preclinical data showing the impact of leriglitazone on myelination”.

“Pleased with the success of our collaboration to date, Minoryx and Braintale teams have decided to extend their partnership exploring the use of biomarkers developed with the Braintale platforms. Now, together, we are contributing to better understand and improve follow-up, treatment, and stratification of patients with this devastating orphan disease”, explains Julie Rachline, co-founder and CEO of Braintale through LallianSe.

 

About BrainTale

BrainTale is an innovative medtech company deciphering white matter to enable better care in neurology and intensive care with clinically validated prognostic solutions. With noninvasive, sensitive and reliable measurements of white matter microstructure alterations, Braintale offers a digital biomarkers platform to support clinical decision-making. Braintale enables the identification of patients at risk, early diagnosis and monitoring of disease progression and the effectiveness of treatments in neurology, in particular for demyelinating diseases, amyotrophic lateral sclerosis and neurodegenerative diseases. Based on more than 15 years of research and development, Braintale’s products are developed to meet the medical needs and expectations of healthcare professionals for the benefit of patients. Since its inception in 2018, the company has implemented a comprehensive quality management system and is now ISO 13485:2016 certified, with a suite of products available on the European market under the European Medical Device Regulation (MDR).

For more information, please visit www.braintale.eu

 

Contacts
Braintale – Julie Rachline, CEO julie.rachline@braintale.eu +33 6 62 42 03 58

 

BRAINTALE, whose head office is 11 rue de l’Académie 67000 – STRASBOURG, is registered in the Trade and Companies Register under number 840 995 138 RCS STRASBOURG

Last update : 09/19/2022