The Food and Drug Administration (FDA) has granted Fast Track designation to LB1148 to reduce adhesions following abdominal or pelvic surgery.
LB1148 is an oral formulation of a broad spectrum serine protease inhibitor designed to neutralize the activity of digestive proteases released from the gut during surgery. The Company believes LB1148 has the potential to reduce damage to gastrointestinal (GI) tissues by inhibiting these digestive proteases, thereby accelerating the return of normal GI function and shortening the duration of postoperative hospital stays.
A multicenter, randomized, double-blind, placebo-controlled phase 2 trial (PROFILE; ClinicalTrials.gov: NCT02836470) has been initiated to assess the efficacy, safety and tolerability of LB1148 for the treatment of intra-abdominal adhesions and postoperative ileus in approximately 120 adults undergoing elective bowel resection.
“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 postop indications where it is being investigated in the clinic,” said Tom Hallam, PhD, chief executive officer of Palisade Bio.
In January 2021, the FDA granted Fast Track designation to LB1148 for the treatment of postoperative GI dysfunction associated with pediatric cardiovascular surgery. The Company also plans to initiate a phase 3 trial in neonatal patients undergoing elective on-pump open-heart surgery to correct congenital heart defects in 2021.
Palisade Bio receives FDA Fast Track designation for LB1148 for reduction of adhesions following abdominal and pelvic surgery. [press release]. Carlsbad, CA: Palisade Bio, Inc.; May 13, 2021.