GB Therapeutics acquires Phase III Parkinson's molecule
GB Therapeutics (GBt) has entered into an agreement with Italian-owned European pharmaceutical group Chiesi Farmaceutici for an exclusive license to Chiesi's CHF1512 molecule, to be known in the future as GT1512. Chiese will make an equity investment in GBt.
GB Therapeutics (GBt) has entered into an agreement with Italian-owned European pharmaceutical group Chiesi Farmaceutici for an exclusive license to Chiesi's CHF1512 molecule, to be known in the future as GT1512. Chiese will make an equity investment in GBt.
The compound is a methylester of levodopa (LDME), melevodopa, combined with the decarboxylase inhibitor carbidopa. Therapeutic doses of GT1512 can be dissolved in a modest quantity of water that can be swallowed easily by Parkinsonian patients. GT1512 is thus completely transformed into levodopa and enters the blood stream, thereby offering a more predictable and constant levodopa plasma level, which may prevent motor complications.
The phase III clinical development for Parkinson's disease patients was completed in Europe, leading to the registration in Italy. Additional Phase III trials to meet FDA and ICH guidelines targeting motor fluctuations are expected to commence in the first quarter of 2006.
'There is a significant unmet medical need for a medication to allow Parkinson's sufferers, especially those with fluctuating response to treatment, to have an option to take an oral liquid therapy that might significantly improve the reliability and stability of levodopa absorption and plasma levels, thereby increasing the efficacy, safety and tolerability of levodopa treatment,' said Anthony Giovinazzo, presi-dent and ceo of GBt.