Products

VRS-808

     

Therapeutic Protein/Peptide Component:

 

Indication(s): 

Glucagon   Prevention of nocturnal hypoglycemia in type 1 diabetics (primarily children)
     

Owner

 

 

Versartis    
     

Key Attributes:

 

Development Status:

  • Sustained glucagon levels for 8-10 hr post-dose (minimal peak levels)
  • Consistent elevation of glucose for 8-10 hr post-dose (during fasting)
  • Safety profile expected to be comparable to approved product
  • Stable liquid small volume injection (27-30 G needle) administered with autoinjector
 
  • Preclinical studies completed in rats, dogs, and monkeys
  • Pharmacokinetics in rats, dogs and monkeys
  • Proof of concept efficacy in fasting dog model
  • Non-GLP single dose toxicology in rats