The Food and Drug Administration (FDA) has granted Fast Track designation to LB1148 (Leading BioSciences) for the treatment of postoperative gastrointestinal (GI) dysfunction associated with pediatric cardiovascular surgery.
LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. The Company believes that LB1148 may reduce the risk of damage to GI tissues, accelerate the return of normal GI function, and shorten the duration of postoperative hospital stays.
The designation is based on positive topline data from a phase 2 study of 120 adults following open-heart surgery. Findings showed that treatment with LB1148 demonstrated a 30% improvement in the time to normal bowel function, along with a 1.1-day reduction in the average length of stay in the intensive care unit and a 1.2-day reduction in the average hospital length of stay.
The Company plans to initiate a phase 3 trial of LB1148 in neonatal patients undergoing elective on-pump open-heart surgery to correct congenital heart defects in 2021.
“We are thrilled that the FDA granted Fast Track designation to LB1148 for this indication. We believe this recognizes LB1148’s potential to demonstrate meaningful improvements in bowel recovery that are commensurate with the improvements demonstrated in our phase 2 study in adult heart surgery patients,” said Tom Hallam, PhD, CEO of Leading BioSciences.
The Company is also investigating LB1148 in a phase 2 study for the treatment of postoperative ileus and intra-abdominal adhesions in patients undergoing elective bowel resection.
For more information visit leadingbiosciences.com.
1. Leading BioSciences announces FDA Fast Track designation granted to LB1148 for the treatment of postoperative gastrointestinal dysfunction associated with pediatric cardiovascular surgery. [press release]. Carlsbad, CA: Leading BioSciences, Inc.; January 13, 2021.
2. Leading BioSciences announces top line phase 2 data demonstrating LB1148 achieves primary endpoint with statistically significant improvement in bowel function following cardiovascular surgery. [press release]. Carlsbad, CA: Leading BioSciences, Inc.; March 24, 2020.