Open-Label Extension Study to Assess GLM101 in PMM2-CDG Patients

Exclusion criteria

• . Has any other condition that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the participant or preclude the participant's successful completion of the study.
• . Diagnosis of congenital disorder of glycosylation (CDG) other than PMM2; Diagnosis is defined as biallelic pathogenic and/or likely pathogenic variants, or, in the case of variants of uncertain pathogenicity, demonstration of bi-allelic variants AND the defined CDG enzyme activity consistent with a diagnosis of the CDG other than PMM2 CDG.
• . If not enrolling directly from a parent study (i.e., more than 28 days from Final Treatment visit in a parent study to date of consent), has an active infection requiring parenteral antibiotics, antivirals, or antifungals or treatment with systemic steroids within 7 days prior to Screening;
• . ALT or AST \>3× ULN OR total bilirubin \>2× ULN or INR \>1.5 (if no anti-coagulation treatment) or INR \> 4 (if participant on anti-coagulation treatment) considered clinically significant;
• . Has a history of liver transplant;
• . Has a history of drug or alcohol use disorder within the 12 months prior to Screening;
• . If not enrolling directly from a parent study (i.e., if more than 28 days from Final Treatment visit in a parent study to date of consent), has had a major surgical procedure within 30 days prior to Screening;
• . Has laboratory value(s) outside the laboratory reference range considered clinically significant and not related to PMM2-CDG;