Arrivo Announces FDA Fast Track Designation for RABI-767 for Patients with Acute Pancreatitis Predicted to Progress to Severe Disease

Patients who progress to severe acute pancreatitis can experience extended, costly hospital stays, with significant rates of organ failure and mortality.

RABI-767 is a novel lipase inhibitor currently in a Phase 2a clinical trial.

MORRISVILLE, N.C.--(BUSINESS WIRE)--Arrivo BioVentures announced today that the U.S. Food and Drug Administration (FDA) granted its subsidiary, Panafina Inc., Fast Track Designation for its investigational new drug, RABI-767, for the treatment of patients with acute pancreatitis predicted to progress to severe disease. The designation will progress the review of the novel therapy, bringing it to patients in 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, CEO of Arrivo BioVentures. “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 with no approved treatments for patients. As a leading cause of hospitalization for gastrointestinal diseases, more than 330,000 patients with acute pancreatitis are hospitalized each year in the U.S.

Arrivo’s ongoing Phase 2a study evaluates the safety and efficacy of RABI-767 in patients predicted to develop severe acute pancreatitis. This 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 Dr. Tim Gardner, professor at The Geisel School of Medicine at Dartmouth and lead investigator for the Phase2a 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.”

For more information on Arrivo or RABI-767, please visit www.arrivobio.com.

About Arrivo BioVentures LLC

Arrivo is propelled forward by its insatiable curiosity and drive to solve complex problems and help millions of patients globally. Working in partnership with investors, innovators, and pharmaceutical companies, Arrivo is always seeking solutions for unmet medical needs. Arrivo has a portfolio of diverse drug candidates with the potential to be first-in-class or best-in-class.

Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit www.arrivobio.com.