Phosphagenics, Nestlé Nutrition’s Phospha E trial updates
Dated: 14 February 2008
Phosphagenics Limited and Nestlé Nutrition has announced that their joint phase 2 human clinical trial to establish the efficacy of Phosphagenics’ Phospha E in the management of metabolic syndrome is advancing at three sites in Adelaide, Australia.
Based on current recruitment rates of study participants, the double-blind phase 2 trial, which is fully funded by Nestlé, is expected to be completed in mid-2008.
This phase 2 clinical trial follows two pre-clinical dose response trials completed by Nestlé and Phosphagenics in 2006.
The results of those studies confirmed that, when given orally, Phospha E significantly reduces many of the key biomarkers associated with metabolic syndrome.
Metabolic syndrome is characterised by a group of risk factors that increase the risk of diabetes, coronary heart disease and other diseases associated with plaque build up in artery walls.
The companies have agreed the principal terms of a commercialisation agreement, which will grant a worldwide exclusive license to Nestlé for the use of Phospha E in medical foods and for Phosphagenics to be the exclusive manufacturer and supplier of Phospha E to Nestlé.
The final commercial agreement is due to be signed on completion of the phase 2 trial.