Arrivo Secures FDA Fast Track Status for RABI-767 Targeting Acute Pancreatitis Patients Likely to Develop Severe Disease
Monday, July 15, 2024
Arrivo BioVentures announced today that its subsidiary, Panafina Inc., has been granted Fast Track Designation by the FDA for RABI-767, an investigational new drug intended for patients with acute pancreatitis who are at risk of progressing to severe disease. This designation expedites the review process for the drug, potentially speeding up its availability to patients.
CEO Steve Butts emphasized the critical need for effective treatments in acute pancreatitis, a serious condition currently lacking approved therapies. RABI-767, a novel small molecule lipase inhibitor, targets fat necrosis—a key factor contributing to tissue damage, systemic toxicity, organ failure, and mortality in severe cases of the disease. Each year, more than 330,000 patients in the U.S. are hospitalized for acute pancreatitis, highlighting the urgent demand for new treatment options.
Arrivo is currently conducting a Phase 2a study to evaluate the safety and effectiveness of RABI-767 in patients predicted to develop severe acute pancreatitis. This study, which is multicenter, randomized, and open-label, 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.
Dr. Tim Gardner, the lead investigator from The Geisel School of Medicine at Dartmouth, emphasized that RABI-767 has the potential to improve outcomes, reduce hospitalizations, and save lives, particularly for patients at high risk of severe acute pancreatitis. The therapy aims to address the significant mortality rates associated with this condition, offering hope to thousands of patients each year.
Source: businesswire.com
