GLM-101
- Generic Name
- GLM-101
Therini Bio's THN391 Shows Promise in Phase 1a Trial for Neurodegenerative Diseases
• Therini Bio's novel monoclonal antibody THN391, targeting fibrin-driven neuroinflammation, demonstrated positive safety and tolerability results in Phase 1a trials with healthy volunteers.
• The drug candidate showed a clean hematological profile without affecting coagulation pathways, and its pharmacokinetic profile supports convenient once-monthly dosing regimens.
• Following these encouraging results, Therini Bio plans to advance THN391 into Phase 1b trials for both Alzheimer's Disease and Diabetic Macular Edema, addressing fundamental root causes of neurodegeneration.
Glycomine Secures $115M Series C Funding to Advance Novel Treatment for PMM2-CDG Rare Disease
• Glycomine has raised $115 million in Series C funding to advance GLM101, a potential first-ever treatment for PMM2-CDG, a rare genetic disorder affecting glycosylation with no FDA-approved therapies.
• The company plans to launch a randomized, placebo-controlled Phase IIb trial by mid-2024, enrolling 40-50 patients ranging from children to adults, with data expected by mid-2026.
• GLM101 is a lipid nanoparticle-delivered mannose-1-phosphate replacement therapy that showed promising results in early Phase II trials, demonstrating improvements in ataxia symptoms among nine patients.
Caris Life Sciences Secures $168 Million in Funding to Advance Precision Medicine Platform
• Caris Life Sciences has raised $168 million in a growth capital funding round led by Braidwell LP, bringing their total capital raised since 2018 to $1.86 billion.
• The company recently launched MI Cancer Seek®, the first FDA-approved Whole Exome and Whole Transcriptome Sequencing-based assay for molecular profiling of solid tumors in both adult and pediatric patients.
• Funds will support Caris's mission to expand access to their precision medicine technologies and further develop their AI-driven molecular profiling capabilities for cancer diagnosis and treatment selection.
Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial
• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial.
• The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users.
• Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy.
• The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.
FDA Grants Fast Track Designation to Glycomine's GLM101 for PMM2-CDG Treatment
• The FDA has granted Fast Track designation to Glycomine's GLM101, a mannose-1-phosphate replacement therapy, for treating phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG).
• GLM101 is currently in a Phase 2 clinical study involving adult and adolescent patients, with plans to expand enrollment to pediatric patients aged two years and older.
• Initial data from the Phase 2 study suggests promising clinical benefits with GLM101, showing good tolerability and only mild to moderate adverse events reported to date.
• Fast Track designation will allow for more frequent interactions with the FDA, potentially accelerating the approval process for GLM101, addressing a significant unmet need.
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