Formac Pharmaceuticals reports positive outcome of phase 1 clinical study
Positive results open up new avenue for formulating poorly soluble active pharmaceutical ingredients (APIs).
Leuven, Belgium-- March 18, 2012- Formac Pharmaceuticals NV and its partner W.R Grace and Co., a global leader in silica gel manufacture, today announced the outcome of a phase 1 proof-of-concept study. In this open-label, randomized, single-dose, two-way crossover study, twelve fasted healthy volunteers received treatments consisting of a capsule formulation comprising 33.5 mg of fenofibrate formulated with mesoporous silica (FP 250 formulation) and a marketed capsule based formulation containing 67 mg of micronized fenofibrate (Lipanthyl®). Administration of the FP 250 formulation gave rise to statistically significant higher systemeic exposure (54% increase in dose-normalized AUC0-24h), and higher plasma concentrations (77%increase in dose-normalized Cmax) of fenofibric acid (active metabolite of fenofibrate) when compared to the marketed formulation. No adverse events were reported after administration of the FP 250 formulation.
Laurent Schueller, CEO of Formac commented: "We are extremely pleased with the results from the FP 250 clinical study, which is the first-ever study to demonstrate the bioavailability enhancing properties of mesoporous silica in man. The results corroborate the promising findings we have obtained in numerous preclinical models and also demonstrate that Formac Pharmaceuticals NV, through its partnership with W.R. Grace can provide an integrated and innovative solution for the development of poorly soluble compounds from early phases to commercial production."
In 2011, Formac Pharmaceuticals and Grace entered into a strategic partnership to develop mesoporous silica materials for the delivery of poorly soluble compounds. This partnership combines Formac's expertise in silica-based drug delivery and Grace's expertise in synthesis and manufacture of customized silica materials.