Date: 2014-06-25
Type of information: Preclinical data
phase: preclinical
Announcement: preclinical results
Company: Flamel Technologies (France)
Product: once-a-week formulation of exenatide based on Medusa drug delivery platform
Action
mechanism: Exenatide is a glucagon-like peptide-1 agonist (GLP-1 agonist) used to treat type 2 diabetes. The drug is loaded in Medusa™’s hydrogel (nano- or micro-gel) via non-covalent, hydrophobic and electrostatic, bonds. Once in the body, the hydrogel releases the drugs in a controlled manner: the transient, non-covalent interactions dictate the pharmacokinetic parameters (Cmax and bioavailability in particular) of the released drugs.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On June 25, 2014, Flamel Technologies announced that its once weekly formulation of exenatide, based on its Medusa drug delivery platform, has been successfully tested in minipigs.The product demonstrated close to 100% bioavailability with no initial release spike or burst effect in plasma. Two successive injections were administered with very similar release profiles. There were no adverse clinical signs and excellent local tolerability was observed.The pharmacokinetic profile is compatible with a release over one week in humans. Flamel Technologies expects to report phase I human clinical data in 2015.