Questcor to Begin Phase 2 Acthar Study for ARDS
Questcor Pharmaceuticals (NASDAQ: QCOR) announced today that it will commence a Phase 2 study to explore the efficacy and safety of H.P. Acthar® Gel (repository corticotropin injection) for Acute Respiratory Distress Syndrome (ARDS). The Company's Investigational New Drug (IND) application for the study has been reviewed by the U.S. Food and Drug Administration (FDA) and is now active. ARDS is an acute life-threatening lung condition that can result from pulmonary and non-pulmonary infections or a multitude of other serious conditions. Based on our understanding of its potential mechanism of action, Questcor believes that Acthar could have both steroid-independent and steroid-dependent protective effects in this condition.
The study will seek to enroll up to 210 patients in a 4-week randomized, placebo controlled trial designed to explore the efficacy and safety of several dosing regimens of Acthar in patients with moderate to severe ARDS. The primary objective of the study will be to determine if Acthar increases the number of ventilator-free days during the 28-day treatment period. Secondary endpoints include whether Acthar therapy diminishes mortality, organ failure and the length of hospital or ICU stay.
"Despite advances in supportive care, there are no pharmacologic therapies that address acute respiratory distress