Palisade Bio Inc. (NASDAQ: PALI) has released topline second phase clinical study data in which LB1148 showed a statistically significant effect in expediting bowel function return in patients experiencing elective bowel resection operation.
LB1148 has the potential of simplifying surgery
The company’s CEO, Tom Hallam, said, “These results demonstrate a strong efficacy profile in acceleration of the time to recover bowel function combined with a favorable safety and tolerability profile. 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 findings are crucial for moving forward with critical trials for these indications. Hallam thanked all of the patients who took part in the study, as well as worldwide collaborators. He said they are looking forward to continuing efforts to provide this medicine to patients who need it.
Palisade Bio and Newsoara completed the Phase 2 double-blind, randomized, multicenter, parallel, placebo-controlled clinical study as part of their co-development agreement. The study comprised 120 individuals who had elective colon resection surgery and used both laparoscopic and laparotomy techniques. In addition, patients undergoing stoma formation or anastomosis were also included in the study.
Results show LB1148 is near launch
Newsoara CEO Benny Li said, “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. 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.”