FDA Approves Mast's Study Of Vepoloxamer In Acute Decompensated Heart Failure
By Cyndi Root
Mast Therapeutics announced its intentions to develop vepoloxamer (MST-188) in heart failure. The company reported on its activities in a press release, stating that the Food and Drug Administration (FDA) had approved a Phase 2 clinical study of the agent in patients hospitalized for acute decompensated heart failure. Earlier in 2014, Mast submitted an Investigational New Drug application (IND) to the FDA along with its proposed clinical study, expected to begin recruiting patients in the first half of 2015.
Vepoloxamer
Vepoloxamer shows promise in treating heart failure, a condition wherein the heart muscle fails to pump the sufficient amount of blood to meet the body’s needs. Vepoloxamer has membrane-sealing activity that restores damaged cardiac cells, limits calcium overload, preserves cardiomyocytes, and improves the heart’s contraction abilities. Unlike approved drugs, vepoloxamer salvages cardiac tissue, which could reduce hospital admissions and mortality. The study approved by the FDA will evaluate safety and efficacy of multiple doses of vepoloxamer in patients hospitalized for acute decompensated heart failure.
The United States Adopted Names (USAN) Council assigned "vepoloxamer" as the unique name for the active pharmaceutical ingredient (API) in MST-188 in order to differentiate the drug from non-purified poloxamers. Mast is also studying the agent in a Phase 3 EPIC trial of sickle cell disease and in a Phase 2 study of acute limb ischemia.
About Mast Therapeutics
Mast Therapeutics’ Molecular Adhesion and Sealant Technology (MAST) platform leverages purified and non-purified poloxamers to treat microvascular blood flow and damaged cell membranes. In August 2014, the company provided an update on its clinical and preclinical programs. The company states that targeting pathologies characterized by membrane dysfunction is a substantial commercial opportunity. The company states that it has an 18-month head start on its nearest competitor due to the Phase 3 study of sickle cell disease. Mast states that it has viable products and the funding to move them through development. The company expects to report data from several trials in 2015.