Arrivo's RABI-767 Gets FDA Fast Track for Severe Acute Pancreatitis

Arrivo BioVentures, based in Morrisville, North Carolina, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its subsidiary, Panafina Inc., for their investigational drug RABI-767. This designation is intended for the treatment of patients with acute pancreatitis that is expected to escalate to severe disease. The Fast Track status will expedite the review process, potentially bringing the new therapy to patients more swiftly.

Steve Butts, CEO of Arrivo BioVentures, emphasized the critical need for effective treatments for acute pancreatitis and expressed optimism that RABI-767 could offer hope to those suffering from this severe and expensive condition. Acute pancreatitis is a major health issue with no currently approved treatments, leading to over 330,000 hospitalizations annually in the United States.

RABI-767 is a novel, small molecule lipase inhibitor designed to interrupt the toxic chain reaction of fat necrosis, a leading cause of tissue damage, systemic toxicity, organ failure, and death in severe acute pancreatitis. The drug aims to address the unmet medical need for a treatment that can mitigate the progression of this life-threatening condition.

Arrivo BioVentures is currently conducting a Phase 2a clinical trial to evaluate the safety and efficacy of RABI-767 in patients likely to develop severe acute pancreatitis. This study is being carried out across multiple centers and follows a randomized, open-label format. It investigates the effects of a single dose of RABI-767, administered via endoscopic ultrasound-guided peripancreatic injection, in combination with the standard-of-care treatment, compared to the standard-of-care treatment alone.

Dr. Tim Gardner, a professor at The Geisel School of Medicine at Dartmouth and the lead investigator for the Phase 2a trial, highlighted the potential of RABI-767 to significantly improve patient outcomes, reduce lengthy hospital stays, and save lives. He pointed out that severe acute pancreatitis has high mortality rates, and RABI-767 could meet the urgent medical needs of thousands of patients who progress to this severe stage each year.

Arrivo BioVentures is dedicated to addressing complex medical challenges and improving global health outcomes. They work in collaboration with investors, innovators, and pharmaceutical companies to develop solutions for unmet medical needs. The company has a varied portfolio of drug candidates, each with the potential to be either first-in-class or best-in-class.

Located in Morrisville, North Carolina, near Research Triangle Park, Arrivo BioVentures continues to drive forward its mission with a relentless curiosity and commitment to solving complex health issues.