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Palisade Bio and Newsoara Announce Positive Topline Efficacy Results from Phase 2 Study of LB1148 Demonstrating Accelerated Return of Bowel Function After Gastrointestinal Surgery
Statistically significant 1.1-day acceleration in return of bowel function Favorable overall safety profile in 120 patients CARLSBAD, Calif. and SHANGHAI,
About this update from Palisade Bio, Inc.
[{"type":"text","content":"Statistically significant 1.1-day acceleration in return of bowel function Favorable overall safety profile in 120 patients CARLSBAD, Calif. and SHANGHAI, China, July 29, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) and co-development partner Newsoara today announced positive topline Phase 2 clinical trial data that LB1148 had a statistically significant (p=0.0008) effect in accelerating the return of bowel function in patients undergoing elective bowel resection surgery. “These results demonstrate a strong efficacy profile in acceleration of the time to recover bowel function combined with a favorable safety and tolerability profile,” said Tom Hallam, Ph.D., CEO of Palisade Bio. “We believe LB1148 can simplify the surgical journey for these patients, helping them get better faster, while potentially reducing costs to the healthcare system. Further, LB1148 has now shown statistically significant acceleration of return of bowel function in a Phase 2 study for cardiovascular surgery and in a Phase 2 study for GI surgery. These data lay the important groundwork for proceeding to pivotal studies for these indications. We are grateful to all patients that participated in this trial as well as our international collaborators, and we look forward to continued efforts to bring this therapy to patients in need.” “We are delighted that the results from our Phase 2 study brings us another step closer to potentially launching the first protease inhibitor indicated to accelerate the return of GI function,” said Dr Benny Li, Newsoara’s Chief Executive Officer. “Delayed return of bowel function impacts millions of patients across the globe every year, yet the treatment landscape for this global population has been relatively unchanged for decades. LB1148 has the potential to be transformative for patients undergoing major surgery to address this significant unmet need.” The Phase 2, multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial was completed as part of a co-development agreement between Palisade Bio and Newsoara. The study involved 120 patients undergoing elective bowel resection surgery and included laparotomy and laparoscopic surgical approaches. In addition, the study included patients undergoing either anastomosis or stoma creation. The primary outcome was recovery of bowel function measur...