Leading BioSciences announces Fast Track Designation for LB1148

Leading BioSciences, a privately held company that recently entered into a definitive agreement for a reverse merger with Seneca Biopharma to form Palisade Bio, Inc., announced that the U.S. Food and Drug Administration has granted Fast Track Designation to LB1148 for the treatment of postoperative gastrointestinal dysfunction associated with pediatric heart surgery. Previously, LBS announced positive topline data from a Phase 2, randomized, double-blind, placebo-controlled, study that enrolled 120 adult open-heart surgery patients. This trial evaluated return of bowel function in adult patients undergoing open-heart surgery with cardiopulmonary bypass. The LB1148-treated group demonstrated a statistically significant improvement of approximately 30% in the median time to return of normal bowel function as compared to the placebo treatment group. Generally, treatment with LB1148 was well tolerated. Adverse events were similar between the treatment groups and not unexpected for the subject population. In addition to adult open-heart surgery patients, there is a tremendous unmet need for improving GI recovery in neonates undergoing heart surgery. By accelerating a return of GI function and full feeding following surgery, LB1148 may minimize the risk of developmental delays and other serious complications. LBS is planning to initiate a randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical trial of LB1148 in neonatal patients undergoing elective on-pump open-heart surgery to correct congenital heart defects in 2021.