(BUSINESS WIRE)–AceLink Therapeutics, Inc., a clinical stage biopharmaceutical company developing the next generation of oral substrate reduction therapies (SRTs) to address significant unmet medical needs and improve the quality of life of patients with inherited disorders of glycosphingolipid metabolism, today announced the appointment of Pedro Huertas, M.D., Ph.D., as Chief Medical Officer (CMO). Dr. Huertas is a distinguished expert in rare diseases and will serve as an important resource for AceLink as the company advances its development pipeline.

“We are thrilled to welcome Dr. Huertas to our executive team during a pivotal time, as our lead asset, AL01211, enters into two Phase 2 clinical trials later this year,” said Jerry Shen, Ph.D., Chief Executive Officer and Founder of AceLink Therapeutics. “Dr. Huertas brings a breadth of expertise across clinical development, regulatory affairs and medical affairs that is perfectly aligned with our vision to deliver life-changing oral therapies to patients with rare diseases. One of his most remarkable accomplishments was filing the Biologics License Application for Fabrazyme, which went on to receive regulatory approval from the FDA. We believe Dr. Huertas’s proven leadership, having served as CMO at many biotechs over the years, coupled with his unparalleled clinical vision in the rare diseases space will elevate AceLink as the company enters the next stage in its lifecycle.”

“I am delighted to join AceLink at this stage in its development. Rarely one finds a company that manages its assets so well and the exciting Phase 1 data collected positions AceLink to further advance AL01211 into Phase 2 studies,” said Pedro Huertas, M.D., Ph.D., Chief Medical Officer of AceLink. “I’m eager to leverage my expertise to bring forward life-changing treatments for patients with rare diseases who are in desperate need for convenient oral therapies.”

Dr. Pedro Huertas has 30 years of pharmaceutical industry experience in research and development, medical affairs, and regulatory affairs in therapeutics for rare genetic diseases. Prior to joining AceLink, Dr. Huertas was Chief Medical Officer for Eloxx Pharmaceuticals, Sentien Biotechnologies, Inozyme Pharma, Novazyme Pharmaceuticals, and Kriya Therapeutics. His prior experience includes positions at Pfizer, Shire, Genzyme, Amicus Therapeutics, Novazyme, Advanced Cell Technology and StemCells, Inc.

Dr. Huertas is a graduate of Stanford University (M.S., Biochemistry), Harvard University (Ph.D., Cell and Developmental Biology), Harvard Medical School (M.D.), and MIT Sloan School of Management (M.S., Management). He also trained in Internal Medicine, Rheumatology and Palliative Care at Massachusetts General Hospital.

About AL01211

AL01211 is a proprietary, non-brain penetrant GCS inhibitor with excellent potency (single-digit nanomolar IC50), great selectivity, and other favorable drug properties that support once-daily oral administration. AL01211 offers a much-needed oral small molecule therapy as an alternative to current therapies for Fabry disease that require frequent intravenous infusions. Phase II clinical studies of AL01211 in patients with Fabry disease are planned to start in 2023.

About AL00804

AL00804 is a highly brain penetrant GCS inhibitor being developed for the treatment of neuropathic glycolipid storage diseases including Gaucher disease, GM2 gangliosidosis (Tay-Sach and Sandhoff disease), GM1 gangliosidosis, and possibly certain genetic forms of Parkinson’s disease.

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 and diseases. GCS inhibitors reduce the production of glycosphingolipids, thereby exerting beneficial effects to diseases such as Fabry disease and Gaucher disease, which are caused by the accumulation of these lipids.

About AceLink Therapeutics, Inc.

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