Glycomine, Inc., a clinical-stage biotechnology company, has announced the initiation of dosing in its global Phase 2b clinical trial of GLM101, a mannose-1-phosphate replacement therapy for the treatment of phosphomannomutase-2 congenital disorder of glycosylation (PMM2-CDG). The study, known as the POLAR trial, is designed as a randomised, placebo-controlled investigation of both children and adults living with this ultra-rare disease.
The Phase 2b trial will enrol approximately 50 participants aged four years and older across around 16 sites in 10 countries. The trial is structured into two phases: a 24-week randomised, double-blind, placebo-controlled segment (Part A), followed by a 24-week open-label extension (Part B). The primary endpoint of the study is an improvement in ataxia measured using the International Cooperative Ataxia Rating Scale (ICARS). Additional assessments include motor function, cognition, strength, and overall clinical impression of change.
Advent Life Sciences, an investor in Glycomine, highlighted the milestone as a significant step towards addressing the unmet medical needs of patients with PMM2-CDG. The trial will provide critical data on GLM101’s efficacy and safety profile in preparation for potential future regulatory submissions.
About PMM2-CDG
PMM2-CDG is the most common type of congenital disorder of glycosylation, a group of rare, inherited metabolic diseases that affect glycoprotein biosynthesis. The condition is associated with a wide spectrum of symptoms, including developmental delay, impaired motor skills, and multi-organ involvement. There are currently no approved disease-modifying treatments for PMM2-CDG, highlighting the urgent need for new therapeutic options.
