Benzinga | Jul 29, 2021 08:24AM EDT

Palisade Bio and Newsoara Announce Positive Topline Efficacy Results from Phase 2 Study of LB1148 Demonstrating Accelerated Return of Bowel Function After Gastrointestinal Surgery

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 measured as the time from the end of surgery to oral food tolerance and passage of stool.

Results from the study include:

* A 1.1-day improvement in GI recovery in patients receiving LB1148 vs placebo. The median time to return of bowel function was 2.77 days in patients treated with LB1148 and 3.83 days in those receiving placebo (hazard ratio = 1.886; p = 0.0008).

* The difference between groups increased at the 3rd quartile (75th percentile), with LB1148 (3.4 days) demonstrating a 1.5-day faster recovery of bowel function compared to placebo (4.9 days).

* LB1148 was well tolerated with only 10.9% and 4.8% of patients in the LB1148 group and placebo group, respectively, experiencing a drug-related adverse event.

* The most common drug-related adverse events were GI disorders (LB1148 4.7% vs. placebo 3.2%). No drug-related serious adverse events occurred in the trial.

Dr. Michael Dawson, M.D., Palisade Bio's Chief Medical Officer added, "It's very encouraging that the accelerated return of bowel function due to LB1148 in this study is larger in magnitude than any of the five controlled studies that were submitted to the U.S. FDA for approval of Entereg, the only approved product in this indication. Full results from this study are expected to be reported at an upcoming surgical-focused medical conference later this year."

Based on the beneficial clinical outcomes and good safety profile observed to date in phase 2 trials in both CV surgery and GI surgery, Palisade Bio and Newsoara plan to advance LB1148 to pivotal Phase 3 clinical trials for accelerating the return of bowel function for major surgical indications.