AceLink Presents Phase 1 Study of AL01211 to Treat Fabry Disease at WORLD Symposium
AceLink Therapeutics, Inc. (AceLink), an innovative biopharmaceutical company developing transformative therapies for genetic diseases, today presented positive data from a Phase 1 trial evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL01211 in healthy volunteers.
AceLink Presents Preclinical Data on AL00804 at WORLD Symposium
AceLink Therapeutics, Inc. (AceLink), an innovative biopharmaceutical company developing transformative therapies for genetic diseases, today presented data on the development of AL00804, a novel brain penetrant glucosylceramide synthase inhibitor, to treat Gaucher disease and other neuronopathic glycosphingolipid (GSL) storage diseases. AL00804 is a novel, oral, highly brain penetrant glucosylceramide synthase inhibitor (GCSi).
AceLink Therapeutics to present two posters on Fabry Disease and Gaucher Disease at 2023 WORLD Symposium
AceLink Therapeutics, Inc. (AceLink), an innovative biopharmaceutical company developing transformative therapies for genetic diseases, today announced that the company will present two abstracts featuring the development of AL01211 to treat Fabry disease and AL00804 to treat Gaucher disease and other neuronopathic glycosphingolipid storage diseases at the 19th Annual World Symposium Conference, being held in Orlando, Florida, from February 22-26, 2023.
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).
AceLink Therapeutics Received the Acceptance of Investigational New Drug Application from Chinese NMPA
AceLink Therapeutics Inc., a clinical stage biopharmaceutical company developing transformative therapies for kidney diseases, announced today that the IND application of company’s lead compound AL01211 was accepted by Chinese National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE). Dr. Jerry Shen, Chairman, CEO and co-founder of the company said, “this is a big milestone for our young and growing company. AL01211 is a highly specific and potent glucosylceramide synthase inhibitor that is suitable for various non-CNS indications. We are very looking forward to having the clearance and approval from Center for Drug Evaluation (CDE) of NMPA so we can advance to clinical trials in China.”
AceLink Therapeutics Employee awarded the Bronze for The PharmaTimes Clinical Researcher of the Year - The Americas in 2021
Acelink Therapeutics would like to congratulate our team member Jessica Nario for winning the Bronze or third-place award for The PharmaTimes Clinical Researcher of the Year - The Americas (PTCROY) in 2021. Jessica Nario is Associate Director of Clinical Operations, leading several aspects of clinical study conduct including strategic organization and vendor partnerships, clinical study start-up, execution, and closure for Acelink’s lead molecule AL01211 which is now in clinical development within Australia and USA with a potential expansion in Europe. Jessica is an integral member of the team.
AceLink Therapeutics Announced the establishment of AceLink Therapeutics (SuZhou) Co. Ltd.
AceLink Therapeutics Inc., a clinical stage biopharmaceutical company developing transformative therapies for kidney diseases, announced today that it has established AceLink Therapeutics China subsidiary at Suzhou Industry Park, China. Dr. Jerry Shen, Chairman, CEO and co-founder of the company said, “we are very excited to have our China company established. This new entity will allow us to interact closely with our local partners, conduct clinical trials in China and recruit local talents to advance our research and development programs. Our mission is to bring products to China market to help Chinese patients with unmet medical needs and to bring the drug candidates developed in China to the global market”.
AceLink Therapeutics Announced Dosing First Human Subject in a Phase I Clinical Trial
with its GCS inhibitor AL01211
AceLink Therapeutics, Inc. (AceLink), an innovative biopharmaceutical company developing transformative therapies for kidney diseases, today announced dosing the first human subject in its Phase I clinical trial evaluating AL01211, a novel small molecule glucosylceramide synthase (GCS) inhibitor.