Palisade Bio Announces Enrollment of First Patient in Newsoara Phase 3 Clinical Trial Evaluating LB1148

Rhea-AI Summary

Palisade Bio (Nasdaq: PALI) announced the enrollment of the first patient in a Phase 3 clinical trial for LB1148, conducted by its partner Newsoara Biopharma in China. This milestone is expected to advance the development of LB1148, a serine protease inhibitor aimed at protecting gastrointestinal integrity in surgery patients. The double-blind, randomized trial will evaluate LB1148's efficacy in accelerating bowel function post-abdominal surgery. Achieving clinical and regulatory milestones will trigger payments to Palisade, enhancing its financial outlook as it potentially brings LB1148 to a wider patient base.

Positive

• Enrollment of first patient in Phase 3 trial for LB1148, indicating progress in clinical development.
• Potential for LB1148 to address delayed bowel function, impacting millions of patients annually.
• Financial incentives through milestone and royalty payments from Newsoara, upon achievement of clinical milestones.

Negative

• None.

Enrollment triggers milestone payment

Carlsbad, CA and Shanghai, China, April 05, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, announced today that its development partner Newsoara Biopharma Co. Ltd, has enrolled the first patient in its ongoing Phase 3 clinical trial in China. The trial is being fully conducted and funded by Newsoara.

“The start of patient enrollment marks an important milestone for our partner Newsoara’s advancement of its Phase 3 LB1148 study in China. We continue to be encouraged by the potential of LB1148 to protect gastrointestinal integrity in surgery patients and look forward to the forthcoming data readout from Newsoara’s study,” commented J.D. Finley, CEO of Palisade Bio.

LB1148 is a broad-spectrum serine protease inhibitor which acts to neutralize digestive enzymes, potentially reducing intestinal damage. The Phase 3 trial being conducted in China is designed as a multi-centered, randomized, double-blinded, parallel-group, placebo-controlled clinical trial, and will assess the safety and efficacy of LB1148 to accelerate the return of bowel function following abdominal surgery. All patients enrolled in the trial will undergo a scheduled bowel resection surgery that will include either laparotomy or laparoscopic surgical approaches.

“We believe LB1148 has continued to demonstrate the potential to address the delayed return of bowel function, which impacts millions of patients across the globe every year. With the first patient now enrolled in the Phase 3 study, our team is focused on continuing execution of our development plans to advance toward successful completion of the study and data readout. We look forward to potentially bringing LB1148 to patients to improve post-operative outcomes by accelerating postoperative return of GI function and reducing post-surgical adhesions,” said Dr. Benny Li, Newsoara’s Chief Executive Officer.

Under the terms of the existing agreement with the Company, Newsoara is responsible for fully performing and funding the development in China, including this Phase 3 study, and will be required to make milestone payments to Palisade upon achievement of certain clinical, regulatory and, if approved, commercial milestones, and tiered royalty payments on any future annual net sales of LB1148 in greater China.

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 and human disease to develop 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 clinical studies, LB1148 has demonstrated positive results in reducing the incidence and severity of post-surgical abdominal adhesions and potentially accelerating the time to return of postoperative bowel function. LB1148’s current 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.

About Newsoara Biopharma

Newsoara Biopharma is an R&D based biotech company based in Shanghai, China with research laboratories in the Suzhou BioBAY focusing on novel drug research and development to address unmet medical needs in patients with various diseases.

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: the extent of our cash runway; estimates about the size and growth potential of the markets for our product candidates, and our ability to serve those markets, including any potential revenue generated; future regulatory, judicial, and legislative changes or developments in the United States (U.S.) and foreign countries and the impact of these changes; our ability to build a commercial infrastructure in the U.S. and other markets; our ability to compete effectively in a competitive industry; our ability to identify and qualify additional manufacturers to provide API and manufacture drug product; our ability to enter into commercial supply agreements; the success of competing technologies that are or may become available; our ability to attract and retain key scientific or management personnel; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain funding for our operations; our ability to attract collaborators and strategic partnerships; and the impact of the COVID-19 pandemic on our business, and operations, and supply. 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; and the Company’s ability to achieve additional financing to fund future operations. 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. 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.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
833-475-8247
PALI@jtcir.com
Source: Palisade Bio

FAQ

What is the significance of the Phase 3 trial by Palisade Bio for LB1148?

The Phase 3 trial represents a critical milestone in the development of LB1148, which aims to improve gastrointestinal function after surgery.

When was the first patient enrolled in the LB1148 trial?

The first patient was enrolled in the Phase 3 clinical trial on April 5, 2023.

What are the major goals of the LB1148 Phase 3 trial?

The trial aims to assess the efficacy and safety of LB1148 in accelerating the return of bowel function following abdominal surgery.

What financial benefits can Palisade Bio expect from the trial's success?

Palisade may receive milestone payments and tiered royalties on future sales of LB1148 in greater China if the trial meets its clinical and regulatory milestones.

How does LB1148 work in the context of surgery?

LB1148 acts as a serine protease inhibitor, potentially neutralizing digestive enzymes to reduce intestinal damage during and after surgical procedures.