Glycomine has received U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for GLM101 for the treatment of PMM2-CDG. The company is now enrolling study participants in POLAR, a global, randomized, placebo-controlled Phase 2b clinical trial to assess the safety and efficacy of GLM101 in children and adults with PMM2-CDG (ClinicalTrials.gov Identifier: NCT06892288).
PMM2-CDG (also known as CDG-1A or CDG Type 1a) is a rare genetic disease of glycosylation. While currently approved therapies only treat symptoms and are not disease-modifying, Glycomine hopes to change that with the clinical development of GLM101 (ClinicalTrials.gov Identifier: NCT06892288), a mannose-1-phosphate replacement therapy.
Rare genetic diseases are often caused by genetic mutations that lead to protein dysfunction and disruption of biochemical pathways. Glycomine is developing replacement therapies, where delivering a substrate, enzyme, or protein has the potential to restore the missing function. GLM101 is Glycomine’s first drug from its platform and is currently in clinical trials in the U.S. and Europe for the treatment of PMM2-CDG.
Glycomine Announces $115 Million Series C Financing to Advance Lead Drug Candidate, GLM101, into a Phase 2b Clinical Trial for PMM2-CDG
In September 2025, Glycomine initiated dosing in a global, randomized, placebo-controlled Phase 2b study of GLM101 for the treatment of PMM2-CDG.
Data from Glycomine’s natural history study informs update to standard of care.
GLM101 is a mannose-1-phosphate replacement therapy in clinical development as a potential PMM2-CDG treatment.