Drug to Treat Acute Pancreatitis Granted Fast Track Designation by FDA

Panafina Inc.’s investigational new drug, RABI-767, has been granted fast track designation by the U.S. Food and Drug Administration (FDA) to treat patients with acute pancreatitis predicted to progress to severe disease. The designation will progress the review of the novel therapy, bringing it to patients sooner.

RABI-767 is a novel, small molecule lipase inhibitor that halts the highly toxic cascade of fat necrosis, a key driver of tissue injury, systemic toxicity, organ failure and mortality in severe acute pancreatitis. Acute pancreatitis is a serious disorder with no approved treatments for patients.

Arrivo’s ongoing Phase IIa study is evaluating the safety and efficacy of RABI-767 in patients predicted to develop severe acute pancreatitis. The multicenter, randomized, open-label study aims to assess the impact of a single dose of RABI-767 administered via endoscopic ultrasound-guided peripancreatic injection, in combination with standard-of-care treatment compared to standard-of-care treatment alone.

“RABI-767 has the potential to improve patient outcomes, avoid lengthy hospitalizations and save lives,” said Tim Gardner, MD, professor at The Geisel School of Medicine at Dartmouth and lead investigator for the trial. “With significant mortality rates in patients with severe acute pancreatitis, RABI-767 can potentially address the serious unmet medical needs for thousands of patients that advance to severe acute pancreatitis each year.”