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Marc Martinell, Co-Founder and CEO of Minoryx (Photo: Minoryx Therapeutics).
 07.01.2018

Minoryx starts a phase II/III clinical study of MIN-102 for the treatment of adrenomyeloneuropathy

Minoryx Therapeutics –a company specialized in the development of new drugs for orphan diseases, located at the Barcelona Science Park and the TecnoCampus Mataró– announces the start of its pivotal phase II/III clinical trial of MIN-102 for the treatment of adrenomyeloneuropathy (AMN), the most frequent phenotype of X-linked adrenoleukodystrophy (X-ALD). The trial enrolls adult male patients affected by AMN, the most frequent phenotype of X-linked adrenoleukodystrophy (X-ALD).

 

The first patients were dosed at the Vall d’Hebron University Hospital (Barcelona, Spain) by Dr. Josep Gámez and at the Academic Medical Center (Amsterdam, The Netherlands) by Dr Marc Engelen. Recruitment was also initiated at the Institute of Genomic Medicine and Rare Disorders (Budapest, Hungary) by Dr. Maria Molnar. The Advance trial will be initiated in several other European countries (United Kingdom, Germany, France, Italy and Poland) in the coming weeks and in the US by mid-2018.

The Advance trial is a randomized, double-blind, placebo-controlled study with an open-label extension to determine the efficacy and safety of MIN-102, a novel, orally bioavailable and selective PPAR gamma agonist with a superior profile for central nervous system-related diseases and promising in vivo efficacy. The primary outcome is to evaluate the efficacy of MIN-102 on the progression of AMN in male patients, as determined by a motor function test. The trial aims to enroll more than 100 patients and results are expected at the end of 2020. The design and endpoints were finalized following regulatory interactions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

“We are proud to be among the first sites in this trial. The proximity to Minoryx’s ‘homebase’ in Barcelona allowed us to work closely with the company’s scientists during the planning phase,” said Dr. Josep Gámez, coordinator of the department of neurology at the Vall d’Hebron University Hospital.

“The Advance trial is the result of a successful collaboration between scientists, clinical experts and patient associations. MIN-102 brings new hope to patients suffering from AMN, a disease for which no treatment currently exists,” said Dr. Wolfgang Köhler, head of the Department of Neurology, St Georg Clinic in Leipzig, Germany, and principal investigator of the study.

“We have worked and interacted closely with major regulatory authorities and have benefited greatly from their guidance in the design of this trial,” said Dr. Uwe Meya, CMO of Minoryx. “The clinical sites that are participating in this study are the leading expert sites for this orphan disease. We would like to take this opportunity to thank the care-givers, the patients and their families for their continued support.”

“We are proud to have achieved a major milestone at Minoryx with the initiation of the ADVANCE trial. We look forward to continuing the development of MIN-102 in collaboration with the X-ALD community,” said Dr. Marc Martinell, CEO of Minoryx.
 

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