Arrivo Announces FDA Fast Track Designation for RABI-767 for Patients with Acute Pancreatitis Predicted to Progress to Severe Disease
2024年7月15日 - 9:00PM
ビジネスワイヤ(英語)
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.
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.
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