Arrivo BioVentures gains expedited status for potential new pancreatitis drug

A Morrisville-based biopharmaceutical company has received special regulatory status for a potential new treatment for acute pancreatitis.

Arrivo BioVentures said the U.S. Food and Drug Administration (FDA) granted its subsidiary, Panafina Inc., Fast Track Designation for the investigational drug, RABI-767. The designation will accelerate the FDA’s review of the novel therapy, potentially bringing it to patients sooner.

“The Fast Track Designation highlights the high unmet medical need for patients with acute pancreatitis and the importance of finding safe, effective treatments,” said Steve Butts, chief executive officer of Arrivo. “We continue to be excited about the possibility that RABI-767 will provide hope to patients suffering with this life-threatening and very costly disease.”

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 in which the pancreas becomes inflamed and swollen. There are no approved treatments, and more than 330,000 patients are hospitalized with the disease each year in the United States. Patients who progress to severe acute pancreatitis can experience extended, costly hospital stays, with significant rates of organ failure and mortality.

Arrivo’s ongoing Phase 2a study evaluates 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, M.D., professor at The Geisel School of Medicine at Dartmouth and lead investigator for the clinical 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.”

Arrivo is a privately held biopharmaceutical company focused on developing biologics and small molecules to improve patient lives. In addition to RABI-767, the company has a small-molecule drug candidate called SP-624 in clinical development for the treatment of major depressive disorder.

In November 2023, Arrivo closed on $45.25 million in Series B venture capital, bringing to $100 million the total raised since the company’s inception in 2016. The funds are being used to develop RABI-767 and SP-624.