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
Carlsbad, CA, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for avoidance of acute and chronic post-surgical complications following gastrointestinal (GI) surgery, today announced that the U.S. 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 which acts to neutralize digestive enzymes, with the potential to both reduce abdominal adhesions and accelerate the return of bowel function following gastrointestinal surgery. By inhibiting the activity of digestive proteases, the Company believes that LB1148 has the potential to reduce the formation of adhesions in GI tissues and potentially accelerate the time to the return of normal GI function.
“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.
Herbert B. Slade, MD, FAAAAI Chief Medical Officer of Palisade Bio added, “This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address return of bowel function.”
According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation is eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
About Palisade Bio
The Company’s lead program, LB1148, is a broad-spectrum serine protease inhibitor which acts to neutralize digestive enzymes, potentially reducing intestinal damage. In clinical studies, LB1148 has demonstrated positive results in reducing the incidence, extent, and severity of post-surgical abdominal adhesions and potentially accelerating the time to return of postoperative bowel function LB1148 is currently being evaluated in a Phase 2 study to evaluate return of gastrointestinal function, post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection (PROFILE).
The Company believes that addressing the disruption of the intestinal barrier can fundamentally change the way diseases are treated and establish new standards of patient care. For more information, please go to www.palisadebio.com.
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Source: Palisade Bio
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