Palisade Bio (Nasdaq: PALI) Receives FDA “Study May Proceed” Letter for Pivotal Phase 3 Clinical Trial Evaluating LB1148 to Accelerate the Return of Bowel Function Following Abdominal Surgery
Palisade Bio, a clinical stage biopharmaceutical company, has received a "Study May Proceed" letter from the FDA for its Phase 3 trial of LB1148. This trial aims to evaluate LB1148's ability to accelerate bowel function recovery in patients after abdominal surgery. Approximately 600 subjects will be enrolled in this double-blinded, placebo-controlled study. Previous Phase 2 trials demonstrated LB1148's effectiveness in improving GI function and patient outcomes. Palisade plans to commence the trial in the latter half of 2022, highlighting LB1148's potential to benefit post-surgical patients significantly.
- FDA approval for Phase 3 clinical trial of LB1148 is a significant milestone.
- LB1148 has shown statistically significant results in previous Phase 2 trials.
- The Phase 3 trial has the potential to simplify recovery for patients undergoing surgery.
- None.
CARLSBAD, Calif., March 22, 2022 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, announced that the Company received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) for a Phase 3 clinical trial to evaluate LB1148 to accelerate the return of bowel function in adult patients undergoing bowel/abdominal surgery.
The trial is designed as a global, multi-centered, randomized, double-blinded, parallel-group, placebo-controlled clinical trial enrolling approximately 600 subjects, and will assess the safety and efficacy of LB1148. All patients enrolled in the trial will be undergoing a scheduled bowel resection surgery that will include either laparotomy or laparoscopic surgical approaches. Palisade Bio intends to initiate the Phase 3 clinical trial in the second half of 2022.
“In two separate Phase 2 trials—one in cardiovascular surgery patients and one in GI surgery patients —LB1148 has demonstrated statistically significant acceleration of return of GI function. These data have laid important groundwork for proceeding to our Phase 3 trial,” said Tom Hallam, Ph.D., Chief Executive Officer of Palisade Bio. “Now as a late-stage clinical program, LB1148 continues to show promise with a favorable safety and tolerability profile. We are optimistic that our Phase 3 clinical trial will reaffirm these findings and, if successful, will lead to this product being available to patients who could benefit from it.”
“Getting approval for Phase 3 clinical trial is a huge milestone for LB1148,” said Michael Dawson, M.D., Chief Medical Officer of Palisade Bio. “LB1148 could simplify healing from the almost seven million surgeries each year in the U.S. where patients are at risk for postoperative ileus. A quicker return to bowel function means patients recover faster, while potentially reducing costs to the healthcare system.”
About LB1148
LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and the formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to prevent damage to GI tissues, accelerate the time to the return of normal GI function, and shorten the duration of costly post-surgery hospital stays.
About Palisade Bio
Palisade Bio is a clinical stage biopharmaceutical company advancing therapies that aid patients suffering with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio’s innovative lead asset LB1148, is a protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from Phase 2 clinical trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in the return of bowel function and a decrease in the length of stay in ICU and hospital compared to placebo. Palisade Bio believes that its investigational therapies have the potential to address the myriad health conditions and complications associated with the chronic disruption to the gastrointestinal epithelial barrier. For more information, please go to www.palisadebio.com.
Forward Looking Statements
This communication contains “forward-looking” statements, including, without limitation, statements related to expectations regarding Palisade’s plans for clinical development of LB1148, including the anticipated timing of initiation of the Phase 3 clinical trial, and the potential of LB1148 to be commercially available in the future, following successful clinical development. 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 Palisade’s current expectations. Forward-looking statements involve risks and uncertainties. Palisade’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 and the uncertain and time-consuming regulatory approval process. Additional risks and uncertainties can be found in Palisade Bio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021. Palisade 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 Palisade’s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
Palisade Bio Investor Relations Contact:
Dawn Hofmeister
ir@palisadebio.com
Palisade Bio Media Relations Contact:
CORE IR
Jules Abraham
julesa@coreir.com
917-885-7378
FAQ
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