Drug intelligence / Profile preview

FGF21-M5

Development stage
Preclinical
Lead developer
Todd Pharm
Modality
Recombinant Proteins and Enzymes
Administration
Subcutaneous
01

Overview

FGF21-M5 (also known as TODD-B-001) is an engineered recombinant protein variant of human fibroblast growth factor 21 (FGF21) developed by Todd Pharm. It features five point mutations in the C-terminal loop, which confer a significantly higher affinity (approximately 3- to 5-fold) for the co-receptor β-Klotho (KLB) and enhanced activation of the FGF receptor 1c (FGFR1c) complex compared to wild-type FGF21. FGF21-M5 is being developed as a biobetter therapeutic for metabolic dysfunction-associated steatohepatitis (MASH), obesity, and neurodegenerative tauopathies such as Alzheimer's disease. In preclinical models of tauopathy, FGF21-M5 has demonstrated the ability to cross the blood-brain barrier, suppress pathological tau aggregation, attenuate neurodegeneration and neuroinflammation, and prevent synaptic loss.

Other names
FGF21 variant M5FGF-21 variant M5FGF 21 variant M5FGF21-M5 variantFGF-21-M5 variantFGF 21-M5 varianthuman FGF21 variant M5
02

Targets

FGFR1 (Fibroblast growth factor receptor 1)FGFR2 (Keratinocyte growth factor receptor)FGFR3 (Fibroblast growth factor receptor 3)FGFR4 (Fibroblast growth factor receptor 4)KLB (Beta-Klotho)aggregated p-tau (Microtubule-associated protein tau (aggregated/paired helical filament form))

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