The Food and Drug Administration (FDA) has granted Fast Track designation to LB1148 for the acceleration of time to return of bowel function following surgery.
LB1148 is a broad-spectrum serine protease inhibitor designed to neutralize digestive enzymes and potentially reduce intestinal damage. The Company believes that LB1148 may accelerate the time to the return of normal gastrointestinal (GI) function by reducing the formation of adhesions in GI tissues.
In clinical studies, LB1148 has shown to potentially accelerate the time to return of postoperative bowel function by reducing the incidence, extent, and severity of post-surgical abdominal adhesions.
The Company is currently investigating the efficacy, safety, and tolerability of LB1148 for the treatment of postoperative ileus and intra-abdominal adhesions in adults undergoing elective bowel resection in the phase 2 PROFILE study (ClinicalTrials.gov Identifier: NCT02836470).
“Receiving Fast Track designation represents an important regulatory milestone for the Company. Although our current focus is on our adhesions study, this designation provides what we believe is a key component to our future clinical and regulatory strategies as we continue to formulate next steps for studying the return of bowel function,” commented JD Finley, interim CEO of Palisade Bio.
Palisade Bio is granted Fast Track designation from the US Food and Drug Administration for LB1148 for accelerated return of bowel function following GI surgery. News release. Palisade Bio, Inc. Accessed November 22, 2022. https://www.globenewswire.com/news-release/2022/11/22/2560876/0/en/Palisade-Bio-is-Granted-Fast-Track-Designation-from-the-U-S-Food-and-Drug-Administration-for-LB1148-for-Accelerated-Return-of-Bowel-Function-following-GI-Surgery.html.