Palisade Bio LB1148: Clinical Trials Ready for Topline Data Readouts

Palisade Bio Inc. (Nasdaq:PALI), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal complications, recently announced an update to its clinical program for its lead product candidate, LB1148.

This unique serine protease inhibitor reduces intestinal damage by neutralizing digestive enzymes, giving hope to those suffering from GI-related issues. With its promising results, Palisade is revolutionizing the way we tackle difficult to treat gastrointestinal conditions.

Leading up to a highly anticipated readout of data from their Phase 2 adhesions study, LabMice Inc. is making rapid progress with their dose optimization study. The topline data from Phase 2 is expected to offer key insights into future trial design, with topline data from the dose optimization set to come in the third quarter of this year.

J.D. Finley, interim Chief Executive Officer, commented: “We remain focused on our U.S. Phase 2 adhesions study with our lead drug, LB1148, and look forward to our data readout in the coming weeks. We believe the topline data from our Phase 2 study will provide valuable insight related to future trial design.”

At Lineage Cell Therapeutics, we are proud of our recent progress with LB1148 and excited about its potential to revolutionize the way physicians manage the risks associated with surgical GI complications.

We are immensely grateful to the stakeholders who have supported this endeavor, and we remain committed to driving LB1148’s development. We eagerly anticipate the future of this remarkable therapy!

U.S. Phase 2 Adhesions Study

LB1148 is currently under evaluation in a Phase 2 clinical trial to assess its efficacy and determine its potential for reducing intra-abdominal adhesions, accelerating the recovery of gastrointestinal function, and preventing post-operative ileus in patients who have undergone elective bowel resection. With promising results, LB1148 could be an integral component of any treatment plan to improve positive outcomes and reduce recovery times.

PROFILE is helping cancer patients on their journey towards recovery! After completing an initial surgery, many of the patients enrolled in PROFILE are continuing their adjuvant therapy. With the clinical trial protocol in place, these patients have up to eight months to complete their second surgery, with the final patient of the trial expected to finish on June 24, 2023. Excitingly, following the last surgery, the Company is expected to share topline data within four weeks!

Dose Optimization Study

The Company has launched a dose optimization study, with the aim of improving on the risk profile and efficacy of its development program. To date, 8 out of 32 total participants, or 25%, have been enrolled and dosed. Topline data is expected to be reported in Q3 2023, following completion of the study.

About Palisade Bio

Palisade Bio is an innovative biopharmaceutical company that seeks to revolutionize the treatment and prevention of human illness through the development of therapeutics that protect the intestinal barrier.

Drawing on more than thirty years of scientific research that proves the vital role the intestinal barrier plays in overall health, Palisade Bio is speedily bringing to market groundbreaking treatments that support and sustain the integrity of this crucial system.

For those facing post-operative abdominal adhesions, LB1148, our company’s lead program, offers hope. This broad-spectrum serine protease inhibitor neutralizes digestive enzymes, mitigating potential intestinal damage, and prior clinical studies have shown positive results.

We’re continuing to explore LB1148’s potential with our U.S. Phase 2 study called PROFILE, which is evaluating its effectiveness in reducing intra-abdominal adhesions, accelerating the return of gastrointestinal function, and preventing post-operative ileus in subjects undergoing elective bowel resection. With LB1148, we’re providing a glimmer of hope to those facing post-operative abdominal adhesions.

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. 

Forward Looking Statements

We have high hopes for the future of our company. We believe that our product candidates have tremendous growth potential, and are confident in our ability to serve these markets. We are confident in our mission to build a strong commercial infrastructure in the US and other markets. As well, we are confident in our ability to compete in a highly competitive industry and to attract and retain key personnel.

We are relying on our current estimates regarding expenses, revenues, capital, and financing to ensure our success. With all of this in mind, we are keeping a careful eye on future regulatory, judicial, and legislative developments both in the US and abroad, and are taking into account the effect that the novel Covid-19 pandemic has had on our supply and operations. We look forward to continuing to make a positive impact on the business world.

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