Topline data expected in Q3 2023
Carlsbad, CA, July 05, 2023 — Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the completion of patient enrollment in its dose optimization study of LB1148.
“Achieving our enrollment target in this study is an important milestone for our LB1148 clinical program,” commented J.D. Finley, Chief Executive Officer of Palisade Bio. “Importantly, we remain on track for the Phase 2 topline data readout for the prevention of post-surgical abdominal adhesions in the coming weeks. The data from these two studies will provide meaningful information related to our future clinical development of LB1148.”
The dose optimization study was designed to generate valuable pharmacokinetic and pharmacodynamic data across multiple doses in healthy adult volunteers and to determine if a different dosing protocol might enhance the risk profile while simultaneously providing efficacy for the development program moving forward.
About Palisade Bio
Palisade Bio is a biopharmaceutical company focused on developing therapeutics that protect the integrity of the intestinal barrier. The Company utilizes over three decades of research and established science that links the role of intestinal barrier biology with human disease to advance novel therapeutics that target and improve the integrity of the intestinal barrier.
The Company’s lead program, LB1148, is a broad-spectrum serine protease inhibitor that acts to neutralize digestive enzymes, potentially reducing intestinal damage. In prior clinical studies, LB1148 has demonstrated positive results in reducing the incidence and severity of post-surgical abdominal adhesions and potentially reducing the time to return of postoperative bowel function. LB1148’s current U.S. Phase 2 study is evaluating its effectiveness in reducing intra-abdominal adhesions, accelerating return of gastrointestinal function, and the prevention of post-operative ileus in subjects undergoing elective bowel resection (PROFILE).
The Company believes that addressing the disruption of the intestinal barrier can fundamentally change the way diseases are treated and establish new standards of patient care. For more information, please go to www.palisadebio.com.
Forward Looking Statements
This communication contains “forward-looking” statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: progress of studies, including opening additional clinical trial sites, timing of results or data, progress and completion of patient enrollment, including timing thereof and the Company’s co-development partner’s expectation to complete enrollment; regulatory progress and strategy, including potential registration and commercialization of LB1148; the extent of the cash runway; the closing of the underwritten public offering; and expected proceeds from financings. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon the Company’s current expectations. Forward-looking statements involve risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the Company’s ability to advance its clinical programs, the uncertain and time-consuming regulatory approval process; the Company’s ability to achieve additional financing to fund future operations and the Company’s ability to comply with the continued listing requirements for Nasdaq. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023 as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
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Source: Palisade Bio