We remain excited to pursue treatments for ALD as this represents an area with very high unmet medical need. This status could give either molecule a seven-year window of exclusive marketing rights following FDA approval, and, along with its recent Fast Track Designation, gives us confidence in the strategic shift into rare diseases we initiated last year. Poxel CEO, Thomas Kuhn, commented: “ The award of Orphan Drug Designation to both PXL065 and PXL770 by the FDA is an additional regulatory milestone for the development of these potential medicines in X-linked adrenoleukodystrophy, for which there is currently no approved therapy. Both compounds are preparing to enter into Phase 2a clinical Proof-of-Concept (POC) biomarker studies as soon as possible, subject to financing. PXL770 is a novel, first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator. PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to PXL065 and PXL770 for the treatment of patients with adrenomyeloneuropathy (AMN), the most common form of X-linked adrenoleukodystrophy (ALD). POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for serious chronic diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, is pleased to announce that the U.S.
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