Completion of enrollment for Phase 3 study targeted within 18-24 months
In multiple clinical studies, LB1148 has demonstrated statistically significant acceleration in the time to the return of normal GI function, and has the potential to prevent damage to GI tissues and shorten the duration of costly post-surgery hospital stays
Phase 3 study design utilizes same dosing protocol and same primary endpoint as positive Phase 2 study that demonstrated 1.1-day improvement in return of bowel function
CARLSBAD, Calif., June 29, 2022 — Palisade Bio (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the initiation of its Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. The first clinical site in the U.S. is now open.
“Initiation of this study represents a landmark milestone for Palisade Bio as LB1148 enters Phase 3 clinical development. If approved, we believe LB1148 has the potential to be established as the standard of care for millions of patients undergoing abdominal surgeries each year,” commented Tom Hallam, Ph.D., Chief Executive Officer of Palisade Bio.
LB1148, the Company’s lead asset in development, is a novel oral liquid formulation of the well-characterized digestive enzyme inhibitor tranexamic acid, with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. LB1148 is currently being developed for administration prior to surgeries that are at risk of disrupting the intestinal epithelial barrier.
“Delayed postoperative return of bowel function is a common complication after many kinds of surgery and is often an obstacle to patient discharge, which causes an increase in hospital length of stay and expenses, in addition to causing the patient discomfort. To date, LB1148 has been shown to be well-tolerated and has demonstrated statistically significant results in the acceleration in return of GI function. Based on this data and utilizing the proven study design from prior studies, we are advancing LB1148 forward in the clinic. If it is ultimately approved, LB1148 would provide a desperately needed solution to protect intestinal integrity during surgery. We look forward to unlocking the full potential of LB1148,” added Michael Dawson, M.D., Chief Medical Officer of Palisade Bio.
The Phase 3 study is designed as a multi-centered, randomized, double-blind, parallel-group, placebo-controlled clinical trial set to enroll approximately 600 patients, which will assess the safety and efficacy of LB1148. The primary endpoint is time to recovery of the upper and lower gastrointestinal tract following surgery, defined as the time from the end of surgery to the toleration of food and first bowel movement. All patients enrolled in the study will undergo a scheduled bowel resection surgery that will include either laparotomy or laparoscopic surgical approaches. The clinical study will utilize the same dosing protocol used in the Company’s completed Phase 2 study that demonstrated a 1.1-day improvement in return of bowel function. Based on management’s current study projections and timelines, enrollment is targeted for completion within 18-24 months.
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 aim to aid patients suffering with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio’s innovative Phase 3 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 studies 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 for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding Palisade’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the expected completion of enrollment for the Phase 3 study, the potential for LB1148 to transform the current standard of care, if approved, and the potential opportunity for LB1148. 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, the uncertain and time-consuming regulatory approval process, and the Company’s ability to achieve additional financing to fund future operations and to comply with the continued listing requirements of the applicable stock exchange. Additional risks and uncertainties can be found in Palisade Bio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022. 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.
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