Ironwood Pharmaceuticals has secured fast track designation from the US Food and Drug Administration (FDA) for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).
Praliciguat is an investigational, orally administered soluble guanylate cyclase (sGC) stimulator currently in Phase II clinical trials.
Ironwood chief development officer and global development senior vice president Christopher Wright said: “An ever-increasing number of people are suffering from HFpEF, a disease characterized by exercise intolerance, frequent hospitalizations, and increased risk of death, yet there are no approved treatment options.
“We believe praliciguat has the potential to be a new treatment option for these patients and are researching its ability to provide multi-dimensional impact on this disease by increasing tissue blood flow and decreasing cardiac vascular inflammation and fibrosis.
“The Fast Track Designation underscores the seriousness of this disease and that praliciguat has potential to address unmet needs in HFpEF. We look forward to working closely with the FDA to rapidly progress the development of praliciguat for the treatment of HFpEF.”
The FDA grants Fast Track Designation to facilitate the development and expedite the review of drugs that have the potential to treat serious or life-threatening diseases.
A drug granted Fast Track Designation is eligible for several benefits, including more frequent meetings with and communications from the FDA and potentially for Rolling Review of the New Drug Application (NDA) and Priority Review if relevant criteria are met.
Ironwood is currently enrolling patients in a randomized, double-blind, placebo-controlled Phase II trial evaluating praliciguat for the potential treatment of HFpEF. Ironwood expects to enroll approximately 175 patients into the Phase II trial, which is designed to evaluate the safety and efficacy of praliciguat in patients with HFpEF.
Topline data from this study are expected in the second half of 2019.
Source: Company Press Release