Biospherics.net Incorporated has developed the new combination drug product BSN272 for the treatment of general dyslipidemia and familial hypercholesterolemia. Preclinical work at Biospherics.net has shown that the administration of BSN272 to animals more efficacious at reducing hyperlipidemia than either BSN175 or the stilbene component alone. Furthermore, although BSN175 and the stilbene component have been orally administered to humans separately, evidence suggests that the oral administration of mixtures of BSN175 and the stilbene component may affect the absorption of either component. Biospherics.net therefore plans to conduct a Phase 1 pharmacokinetic (PK) study under an IND to determine if an interaction between BSN175 and the stilbene component exists after the administration of a bolus dose of BSN272. Future development of the stilbene component will include assessing the safety of BSN272 after multiple doses, determining the efficacy of BSN272 in the treatment of hyperlipidemia, and evaluating the effect of different delivery systems of the pharmacokinetics of BSN175 and the stilbene component.
BSN175 has been tested up through a Phase 3 human clinical trial. The stilbene component has also been administered to humans, but the doses were lower than those intended to be used by Biospherics.net in BSN272. As a result, Biospherics.net assessed the toxicity of the same batch the stilbene component that will be used in the exploratory Phase 1 PK study in a 28-day rat toxicology study with a toxicokinetic test arm according to Good Laboratory Practices (GLP). The intended doses of BSN175 and the stilbene component for exploratory Phase 1 PK study will be less than those used in the Phase 3 study and 25-fold less than the NOAEL established in the 28-day rat toxicology study, respectively.