- Palisade Bio (NASDAQ:PALI) has added ~12.3% in the pre-market after announcing positive topline data from a Phase 2 trial for LB1148 in patients undergoing bowel resection surgery.
- The multicenter, double-blind trial conducted by Palisade Bio in partnership with Newsoara involved 120 patients who were randomized into LB1148 and placebo.
- The primary outcome was the recovery of bowel function, which was a 1.1-day improvement for patients who received LB1148 compared to those who got the placebo. (hazard ratio = 1.886; p = 0.0008).
- LB1148 was well tolerated and only 10.9% of patients in the LB1148 group and 4.8% in the placebo group reported drug-related adverse events which primarily were GI disorders.
- Commenting on results Michael Dawson, Palisade Bio's chief medical officer said: “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,”
- The company expects to present the full results of the trial at an upcoming medical conference later this year.
Palisade Bio surged in May after the company announced the FDA’s "Fast Track" designation for LB1148 as a potential oral therapy to reduce adhesions following abdominal or pelvic surgery.
Palisade Bio rises on positive mid-stage data for post-surgery medication
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