Acute Pancreatitis with SIRS
We initiated a Phase 2b clinical trial in patients with AP and accompanying SIRS in March 2021. This is a double-blind trial examining three dose levels of Auxora with 54 patients per arm along with a similarly-sized placebo arm. Doses include the two dose levels used previously in the Phase 2a clinical trial and a third dose at half the level of the lower dose used in that study. This dose ranging is intended to establish the lowest efficacious dose in the acute pancreatitis setting and to identify the best dose to confirm efficacy in a registrational trial. Patients in all four groups will be stratified for hypoxemia plus elevated hematocrit. Endpoints will include measures of safety, patient benefit and outcome improvement with a primary endpoint of food tolerance and responder analysis to validate this novel endpoint.
For more details on the clinical trial, please visit: A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS