FDA grants fast track status to LB1148 for quicker return of postoperative bowel function
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FDA granted fast track designation to Palisade Bio’s broad-spectrum serine protease inhibitor, LB1148, for expedited return of bowel function following gastrointestinal surgery, according to a manufacturer release.
Based on prior clinical studies, LB1148 (Palisade Bio) may accelerate the time to the return of normal GI function by reducing the formation of abdominal adhesions. Palisade Bio is currently assessing return of GI function, post-operative ileus and intra-abdominal adhesions in patients undergoing elective bowel resection in a phase 2 study.
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“Receiving Fast Track designation represents an important regulatory milestone for the Company,” JD Finley, interim CEO of Palisade Bio, said in a press release. “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.”
According to the release, LB1148 has shown positive results in decreasing the incidence, extent and severity of postoperative abdominal adhesions thus accelerating the time to return of bowel function following surgery.
The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow Palisade Bio to work closely with the FDA to expedite the review of aspects of LB1148 to improve the efficiency of product development.
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