Leading BioSciences Announces FDA Fast Track Designation Granted to LB1148 for the Treatment of Postoperative Gastrointestinal Dysfunction Associated with Pediatric Cardiovascular Surgery
CARLSBAD, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- 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.
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.”
About Leading BioSciences, Inc.
No Offer or Solicitation:
Important Additional Information Will be Filed with the SEC
You may obtain free copies of the registration statement, proxy statement and all other documents filed or that will be filed with the SEC regarding the proposed transaction at the website maintained by the SEC at www.sec.gov. The registration statement is available free of charge on Seneca’s website at www.senecabio.com, by contacting Seneca’s Investor Relations by phone at (301) 366-4960, or by electronic mail at email@example.com. Investors and stockholders are urged to read the registration statement, proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.
Participants in the Solicitation
Cautionary Statement Regarding Forward-Looking Statements
Leading BioSciences Media Relations Contact:
Leading BioSciences Investor Relations Contact:
Privacy for IoT
Competitive Advantages of Edge Analytics