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.

The AL01211 Phase I trial (https://clinicaltrials.gov/ct2/show/NCT04908462) is being conducted in Australia.  One major goal of the trial is to assess the effects of single ascending dose escalation (SAD) and multiple ascending dose escalation (MAD) in healthy adult participants.  “The design of the Phase I trial will allow us to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult participants. It will also allow us to investigate the food effect on the pharmacokinetics of AL01211 in healthy adults”, said Marvin Garovoy, M.D., Chief Medical Officer of AceLink Therapeutics.

“AL01211 is a novel, once-daily orally administered GCS inhibitor.  Compared with other GCS inhibitors that have been tested clinically, AL01211 has a number of unique properties that makes it an attractive candidate for development.  For example, it does not cross blood-brain barrier and is minimally cleared through the kidney.  These properties make AL01211 ideal to maximizing the benefit for non-CNS diseases such as diseases of the kidney. We are very excited to take this compound into clinical development”, said Jerry Shen, Ph.D, Chief Executive Officer of AceLink Therapeutics.

About AL01211

AL01211 is a proprietary GCS inhibitor with excellent potency (single-digit nanomolar IC₅₀) and great selectivity against a broad range of therapeutic targets.  It possesses favorable drug properties and is intended for once-daily oral administration. 

About GCS inhibitor

GCS (glucosylceramide synthase) catalyzes the first step in the synthesis of glycosphingolipids, a group of bioactive molecules that play important roles in various cellular processes.  A GCS inhibitor reduces the production of glycosphingolipids, thereby exerting beneficial effects to diseases such as Fabry Disease, , Gaucher disease and autosomal dominant polycystic kidney disease (ADPKD).

About AceLink Therapeutics, Inc.

Founded in 2018, AceLink Therapeutics is an innovative biopharma startup focusing on developing safe and effective medicines to address kidney diseases with high unmet needs. The company’s initial focus is to develop novel therapeutics for genetically associated kidney disorders, such as Fabry disease. For more information, please visit www.acelinktherapeutics.com.

Contact Information:

Jerry Shen, Ph.D.

CEO and President

Phone: (925) 262-3145

Email: [email protected]