Minoryx Therapeutics receives approval from Spanish Regulatory Agency to initiate phase 2 study in Friedreich’s Ataxia

Mataró, Barcelona, Spain and Charleroi, Belgium, February 27, 2019- Minoryx Therapeutics, a company specializing in the development of new drugs for orphan diseases, today announces that it has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) to launch a phase 2 clinical trial in Friedreich’s Ataxia with its lead candidate, MIN-102 .

FRAMES trial expected to initiate patient recruitment in upcoming weeks in Spain, Belgium and other European countries.

Professor Alexandra Durr, principal investigator at the Brain and Spine Institute at La Pitié-Salpêtrière University Hospital (ICM) will be the co-ordinator of the new study

The phase 2 trial, FRAMES, is expected to start patient enrollment in the coming weeks in the Hospital La Paz (Madrid), lead by Dr. Francisco Javier Rodríguez de Rivera. The company is also working to open additional sites at medical institutions in Belgium, Germany and France. The upcoming trial is designed to be double-blind and placebo-controlled with the aim of assessing the efficacy and safety of MIN-102 in Friedreich’s Ataxia patients. It will enroll 36 patients aged 12 years or older.
MIN-102 is a novel, orally bioavailable and selective PPAR gamma agonist with a superior profile for central nervous system-related diseases and good in-vivo efficacy. MIN-102 is also in a phase 2/3 clinical trial for the treatment of adrenomyeloneuropathy (AMN), the most common phenotype of X-linked Adrenoleukodystrophy (X-ALD).

The company is also proud to announce the appointment of two key opinion leaders to its scientific advisory board, Dr. Massimo Pandolfo, director of the Laboratory of Experimental Neurology at the Université Libre de Bruxelles, and Dr. Fanny Mochel, group leader at the Brain and Spine Institute of La Pitié-Salpêtrière University Hospital in Paris (ICM).

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Press Release: Minoryx Therapeutics receives approval from Spanish Regulatory Agency to initiate phase 2 study in Friedreich’s Ataxia