Chiesi-developed CHF1512 (to be known in the future as GT1512) is a methyl-ester of levodopa (LDME), melevodopa, combined with the decarboxylase inhibitor carbidopa.
The phase III clinical development for Parkinson’s disease patients was completed in Europe, leading to registration in Italy. Additional phase III trials to meet FDA and ICH guidelines targeting motor fluctuations are expected to commence in Q1 2006.
“We believe that CHF1512 is a safe, well tolerated and effective drug, resulting in a significantly faster onset of action, a significant decrease of the daily experience of disabling motor impairment and uncontrolled movements (dyskinesias) as well as a potential improvement in the functional ability, quality of life and non-motor symptoms associated with the disease,” commented said Anthony Giovinazzo, president & CEO of GB Therapeutics.