Glycomine’s GLM101 Gains the US FDA’s Fast Track Designation to Treat Phosphomannomutase 2-Congenital Disorder of Glycosylation (PMM2-CDG)
Shots:
- The US FDA has granted FTD to the company’s GLM101 for treating phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG)
- The P-II (GLM101-002) trial recruited 15 patients with PMM2-CDG from the US & Spain and received GLM101 (10, 20 or 30mg/kg, for upto 24wks.). Study showed that the drug was well-tolerated without any SAEs reported and will continue recruiting pediatric patients (≥2yrs.)
- GLM101 is a mannose-1-phosphate replacement therapy intended to transfer mannose-1-phosphate directly into cells, bypassing the PMM2 enzyme deficiency to restore pathway function
Ref: Businesswire | Image: Glycomine
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
