Company approaching Phase 2 topline data readout for prevention of post-surgical abdominal adhesions
Continued momentum with execution of ongoing dose optimization study with 25% enrollment complete
Carlsbad, CA, May 24, 2023 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (NASDAQ:PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today provided a clinical program update for its lead product candidate, LB1148, a broad-spectrum serine protease inhibitor which acts to neutralize digestive enzymes, potentially reducing intestinal damage.
“We remain focused on our U.S. Phase 2 adhesions study with our lead drug, LB1148, and look forward to our data readout in the coming weeks. We believe the topline data from our Phase 2 study will provide valuable insight related to future trial design,” commented J.D. Finley, interim Chief Executive Officer. “Additionally, we have made rapid progress in our dose optimization study. We have already dosed eight patients and remain on track to have that topline data in the third quarter of this year.”
“We continue to believe there is great potential for LB1148 to fundamentally transform the way physicians mitigate the risks of acute and chronic GI complications from surgery. We are grateful for the continued support of all our stakeholders and look forward to the continued advancement of LB1148,” concluded Mr. Finley.
U.S. Phase 2 Adhesions Study
LB1148 is currently being evaluated in a Phase 2 study for its effectiveness in reducing intra-abdominal adhesions, accelerating return of gastrointestinal function, and the prevention of post-operative ileus in patients undergoing elective bowel resection (PROFILE).
Many of the patients enrolled in PROFILE have cancer, and most continue adjuvant therapy after completing the initial surgery. Once the patient has been treated and cleared for surgery, the second surgery is scheduled. Per the clinical trial protocol, the patient has up to eight months from the initial surgery to complete the second surgery, and the last patient out is expected on or before June 24, 2023. The Company expects to report topline data within four weeks following the last surgery.
Dose Optimization Study
The Company recently commenced patient enrollment and dosing in its ongoing dose optimization study. The dose optimization study is being conducted to determine if a different dosing protocol might enhance the risk profile while simultaneously providing efficacy for the development program moving forward. The study is expected to enroll approximately 32 healthy subjects. To date eight subjects, or 25%, have been enrolled and dosed. The Company expects to complete enrollment and report topline data in Q3 2023.
