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Palisade Bio Provides Update on U.S. Phase 2 Study Evaluating LB1148 for Post-Surgical Abdominal Adhesions
Topline data readout from study expected in first half of 2023 Carlsbad, CA, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI), a clinical
About this update from Palisade Bio, Inc.
[{"type":"text","content":"Topline data readout from study expected in first half of 2023 Carlsbad, CA, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, is providing an update on its U.S. Phase 2 study evaluating LB1148 for reduction in intra-abdominal adhesions in subjects following elective bowel resection (PROFILE). The Company enrolled a total of 35 of the planned 70 patients in its Phase 2 study. Of the patients enrolled, 31 have completed their first surgery, and nine have completed a second surgery, which is an inflection point for data under the current study protocol. Palisade believes that the data collected to date is sufficient for its evaluation purposes, including an evaluation of its risk profile, and for such reason, the Company is voluntarily ceasing enrollment in the trial. Palisade expects to report topline data from the 35 patients in the first half of 2023. Herbert B. Slade, MD, FAAAAI, Chief Medical Officer of Palisade Bio stated, “We are optimistic about the topline data expected in the first half of 2023 related to the achievement of the primary endpoint of the Phase 2 adhesions study. We remain encouraged by the data demonstrated by LB1148 and are committed to driving its development in a manner that we believe best positions us to provide patient benefit, and ultimately approval.” The Company is currently designing a dose optimization study for all indications to determine if a different dosing protocol would enhance the risk profile while simultaneously providing efficacy. It is anticipated that this study will generate pharmacokinetic and pharmacodynamic data across multiple doses in patients, with enrollment expected to commence in the first half of 2023. “Since joining the Company as CMO last month, I have had the opportunity to review the LB1148 data generated to-date and the current clinical development plan. I believe there is a lot of potential for LB1148 to fundamentally transform the way physicians mitigate the risks of acute and chronic GI complications from surgery. I also believe it is critical for us to put our best foot forward in advancing this important program and see a unique opportunity to fine tune the dose and dosing regimen of LB1148. All of this considered, we have d...