Palisade Bio Receives FDA Fast Track Designation for LB1148 for Reduction of Adhesions Following Abdominal and Pelvic Surgery
7:02 am ET May 13, 2021 (Benzinga) Print
Palisade Bio, Inc. (NASDAQ:PALI), a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational drug LB1148, which has the potential to be the first oral treatment to reduce adhesions following abdominal or pelvic surgery. LB1148 was previously granted Fast Track Designation for the treatment of postoperative GI dysfunction associated with gut hypoperfusion injury in pediatric patients who have undergone congenital heart disease repair surgery in January 2021.
"Fast Track Designation represents another positive step for the clinical development of LB1148 and is a clear recognition of the serious need that exists for patients looking to avoid long-lasting and serious complications from post-surgical adhesions," said Tom Hallam, Ph.D., chief executive officer of Palisade Bio. "We look forward to working closely with the FDA to maintain an open dialogue about the clinical path forward with LB1148, not only for the reduction of surgical adhesions indication, but also in the other post-op indications where it is being investigated in the clinic. We believe that by reducing adhesions, LB1148 has the potential to benefit patients, physicians, hospitals, and payers alike."