AceLink Therapeutics Receives Orphan Drug Designation for its Novel GCS inhibitor AL01211 for the Treatment of Fabry Disease
AceLink Therapeutics, Inc. (AceLink), an innovative biopharmaceutical company developing transformative therapies for genetic diseases, today announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for AL01211 as a treatment for Fabry Disease. “Receiving an FDA Orphan Drug Designation further validates AL01211 as a novel, once-daily orally administered GCS inhibitor as a potential treatment to improve the quality of life of patients suffering from Fabry disease,” said Marvin Garovoy, M.D., Chief Medical Officer of AceLink Therapeutics. “AL01211 was selected based on its unique properties, including high potency and inability to cross the blood-brain barrier, to more effectively treat the peripheral organs affected by Fabry Disease.”
AceLink Therapeutics Received the IND Clearance for AL01211 from Chinese NMPA
AceLink Therapeutics Inc., a clinical stage biopharmaceutical company developing transformative therapies for kidney diseases and rare genetic diseases, announced today that the IND application of company’s lead compound AL01211 was approved by Chinese National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE).