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- | GLM101 / Glycomine
Preclinical, Journal: In vitro treatment with liposome-encapsulated Mannose-1-phosphate restores N-glycosylation in PMM2-CDG patient-derived fibroblasts. (Pubmed Central) - Jul 27, 2024
In vivo characterization of GLM101 revealed its favorable pharmacokinetics, liver-targeted biodistribution, and tolerability profile with achieved systemic concentrations significantly greater than its effective in vitro potency. Taken as a whole, the results described in this report support further exploration of GLM101's safety, tolerability, and efficacy in PMM2-CDG patients.
- GLM101 / Glycomine
NEUROLOGICAL IMPROVEMENT IN THREE ADULT PATIENTS WITH PMM2-CDG AFTER TREATMENT WITH GLM101, A LIPOSOMAL MANNOSE-1 PHOSPHATE (M1P) SUBSTRATE REPLACEMENT POTENTIAL THERAPY (Magnolia Auditorium | Level -1) - Jun 13, 2024 - Abstract #SSIEM2024SSIEM_105;
P2
Treatment with GLM101 was well tolerated and resulted in clinically significant improvements in cerebellar syndrome for the three patients studied. Further longitudinal studies in a larger population are required to confirm this finding.
- || GLM101 / Glycomine
Review, Journal: Liposome-encapsulated mannose-1-phosphate therapy improves global N-glycosylation in different congenital disorders of glycosylation. (Pubmed Central) - May 30, 2024
ALG11-CDG fibroblasts also showed increase in high mannose glycopeptides upon treatment; however, the improvement was not as dramatic as the other two CDG. Overall, our findings suggest that treatment with GLM101 overcomes the genetic block in the glycosylation pathway and can be used as a potential therapy for CDG with enzymatic defects in early steps in protein N-glycosylation.
- GLM101 / Glycomine
Characterization of the Preclinical and Clinical Pharmacokinetics of GLM101, a Liposome-encapsulated Mannose-1-Phosphate Drug Candidate for the Treatment of Patients with PMM2-CDG (Symphony Ballrooms 4-7, First Floor) - Jan 13, 2024 - Abstract #SIMD2024SIMD_240;
- GLM101 / Glycomine
Infusion-Related Reactions are Associated with Pre-existing Anti-PEG Antibodies Detected While Assessing the Immunogenicity of GLM101, a Liposome-encapsulated Mannose-1-Phosphate Drug Candidate for the Treatment of Patient with PMM2-CDG (Symphony Ballrooms 4-7, First Floor) - Jan 13, 2024 - Abstract #SIMD2024SIMD_235;
- GLM101 / Glycomine
Trial completion date, Trial primary completion date: 24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Adults With PMM2-CDG (clinicaltrials.gov) - Sep 13, 2023
P2, N=6, Recruiting, Sponsor: Glycomine, Inc.
Overall, our findings suggest that treatment with GLM101 overcomes the genetic block in the glycosylation pathway and can be used as a potential therapy for CDG with enzymatic defects in early steps in protein N-glycosylation. Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Aug 2023 --> Jun 2024
- GLM101 / Glycomine
Enrollment open: 24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Adults With PMM2-CDG (clinicaltrials.gov) - Jan 9, 2023
P2, N=6, Recruiting, Sponsor: Glycomine, Inc.
Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Aug 2023 --> Jun 2024 Not yet recruiting --> Recruiting
- GLM101 / Glycomine
New P2 trial: 24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Adults With PMM2-CDG (clinicaltrials.gov) - Sep 22, 2022
P2, N=6, Not yet recruiting, Sponsor: Glycomine, Inc.