Full Press Release Details
– Study did not achieve primary efficacy endpoint of reducing adhesions in LB1148 treated patients compared to placebo treated patients post bowel resection surgery
Carlsbad, CA, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Palisade Bio (Nasdaq: PALI), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today reported that the Company’s U.S. Phase 2 PROFILE study evaluating LB1148 for reduction in intra-abdominal adhesions in subjects following elective bowel resection did not achieve its primary endpoint.
“First and foremost, I would like to extend our appreciation to all of the study participants, the clinical staff at the study sites, as well as our team. The PROFILE study has provided us with a definitive outcome and enabled us to quickly make the decision to no longer pursue the adhesions indication,” commented J.D. Finley, Chief Executive Officer of Palisade Bio. “Moving forward, we remain committed to the future of Palisade and are in the midst of encouraging discussions that we believe will lead to pipeline expansion opportunities in high value indications in the GI space. Our focus is now on completing these discussions in order to unlock opportunities and provide value for our shareholders.”
PROFILE Study Design
The Company’s U.S. Phase 2 clinical trial of LB1148 was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in patients undergoing elective bowel resection surgery. This trial was originally designed to evaluate whether patients treated with LB1148 would accelerate the return of GI function in subjects undergoing elective bowel resection with or without a planned stoma. The study commenced in October 2019 and was paused in July 2020 due to COVID-19. During that timeframe, 79 patients were enrolled. The study was restarted in May 2022, where the protocol was amended to evaluate whether patients treated with LB1148 would experience reduction in formation of post-surgical intra-abdominal adhesions in subjects undergoing elective bowel resection with planned stoma take-down. The study enrolled an additional 35 of the planned 70 patients under this amended protocol.
Of the patients enrolled as of May 10, 2023, 31 patients completed a first surgery, and 22 patients completed a second surgery, which is required to evaluate the primary endpoint. Topline data demonstrated that LB1148 did not achieve the primary endpoint of reducing adhesions in LB1148 treated patients (n=11) compared to placebo treated patients (n=11) post bowel resection surgery.
There were 30 serious adverse events (SAEs), with 16 SAEs reported in the LB1148 group (3 related to LB1148) versus 14 in the placebo group.
The Company does not believe the safety data and efficacy results of the Phase 2 PROFILE trial support further development of LB1148 for reduction in intra-abdominal adhesions.
For complete PROFILE study details, please visit clinicaltrials.gov and reference identifier NCT02836470.
Pipeline Expansion Opportunities
Palisade remains focused on the development of novel therapeutics that target and improve the integrity of the gastrointestinal barrier. Management has ongoing business and corporate development initiatives to identify synergistic technologies to expand its pipeline. The Company has been working to identify opportunities to acquire and or in-license development programs within the GI space and is engaged in active discussions. The Company expects to provide an update on these efforts if formal agreements are reached.
Palisade Bio is a biopharmaceutical company focused on developing therapeutics that protect the integrity of the intestinal barrier. 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 its product candidates; the extent of the cash runway; and the ability to diversify the Company’s product pipeline. 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, Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 11, 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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