Leading BioSciences, Inc. (“LBS”), a privately held company that recently entered into a definitive agreement for a reverse merger with Seneca Biopharma, Inc. (Nasdaq: SNCA) to form Palisade Bio, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to LB1148 for the treatment of postoperative gastrointestinal (GI) dysfunction associated with pediatric heart surgery.
“Even with high success rates of neonatal heart surgery, longer-term outcomes in pediatric patients are, to a great extent, dependent upon the speed of postoperative recovery of GI function,” said Dr. Michael Dawson, Chief Medical Officer of Leading BioSciences. “By awarding Fast Track Designation to LB1148 for the treatment of pediatric patients undergoing open-heart surgery, the FDA has recognized LB1148’s potential to accelerate return of bowel function and reduce the risk of serious and life-threatening complications associated with corrective surgeries for these patients, a condition for which no therapy currently exists. This is an important acknowledgement and will improve the frequency of our dialogue with the agency as we initiate our pivotal study.”
The FDA Fast Track program is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. With Fast Track designation LBS is eligible for greater access to the FDA for the purpose of expediting clinical development and creates eligibility for accelerated approval and priority review of LB1148.
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 (p<0.001). 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.
Tom Hallam, Ph.D., Chief Executive Officer of Leading BioSciences added, “There are currently no therapies available to treat GI dysfunction in pediatric patients undergoing open-heart surgery. 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.”
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. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to prevent damage to GI tissues, accelerate the time to return of normal GI function, and shorten the duration of costly post-surgery hospital stays.