Products

VRS-317

     

Therapeutic Protein/Peptide Component:

 

Indication(s): 

Human growth hormone   Growth hormone deficiency in children and adults
     

Owner

 

 

Versartis    
     

Key Attributes:

 

Development Status:

  • Sustained serum levels within therapeutic range for minimum of 2 weeks
  • Lower peak/trough ratio than other approaches (e.g. depots)
  • 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 and monkeys
  • Pharmacokinetics in rats and monkeys
  • Proof of concept efficacy in hypophysectomized rat model
  • Pharmacodynamics (IGF-I responses) in monkeys (repeat dose)