Spanish drug development company Minoryx Therapeutics has begun its first-in-man Phase I clinical trial for its lead compound MIN-102 to treat X-linked Adrenoleukodystrophy (X-ALD).
MIN-102 is a differentiated, peroxisome proliferator-activated receptor (PPAR) gamma agonist indicated to be administered for central nervous system related diseases.
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The trial is designed to evaluate the pharmacokinetics profile, safety, tolerability and brain penetration of MIN-102 after being administered in single ascending doses and multiple ascending doses in healthy volunteers.
The results of the Phase I trial are expected by the end of the year.
Minoryx CEO Marc Martinell said: “The dosing of the first subjects in the Phase I trial is an important milestone for Minoryx.
“It brings us a step closer to offering a potentially meaningful therapeutic option for X-ALD.
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By GlobalData“We eagerly await the clinical readout from this study and plan to initiate clinical trials in X-ALD patients by early 2017.”
X-ALD is a widely occurring peroxisomal disease triggered by genetic mutations of the ABCD1 gene.
The disease affects almost 1:17,000 newborns across the world. It primarily affects males, as well as heterozygous women.
X-ALD causes accumulation of very long chain fatty acids (VLCFA) leading to a neurodegenerative disorder where the most affected tissues are the spinal cord, brain and adrenal cortex.
Minoryx Therapeutics’ MIN-102 targets X-ALD and is the only existing therapeutic drugs for X-ALD.
Image: White matter of brain displaying X-linked adrenoleukodystrophy. Photo: courtesy of Frank Gaillard via Wikipedia.
