Issuance of Additional U.S. Patent No11,202,768 Further Bolsters Palisade Bio’s Patent Portfolio
The Company Continues to Advance LB1148 for Key Indications After LB1148 Topline Efficacy Results from Phase 2 Trial Demonstrated Accelerated Return of Bowel Function Following Gastrointestinal Surgery
CARLSBAD, Calif., Dec. 08, 2021 — Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announces that the United States Patent and Trademark Office (USPTO) has granted a new U.S. patent for the company’s lead investigational drug product, LB1148, for use in treating adhesions and postoperative ileus. The U.S. Patent No. 11,202,768 will issue on December 21, 2021.
The issuance of this grant is the first of a recent patent family directed to the use of LB1148 in treating ileus (disruption of the normal propulsive ability of the intestine) and adhesions, and it confers broad coverage of the components in LB1148 for such treatments until 2037.
“This new patent adds to Palisade Bio’s growing intellectual property (IP) estate for LB1148 and continues to support our clinical studies of LB1148 in surgery patients. It specifically covers the use of LB1148 for the lead indications for which we plan to seek approval,” said Tom Hallam, Ph.D., CEO of Palisade Bio. “This additional IP protection for LB1148 is a major milestone as we advance our clinical pipeline and provide further data from our study of LB1148 for GI surgery patients. With this grant from the USPTO, we now have patents from three distinct families protecting LB1148 and its uses in the U.S., and we continue to pursue and obtain multi-family patent protection of LB1148 outside the United States to strengthen global IP protections.”
Palisade Bio is investigating LB1148 for use in reducing adhesions and postoperative ileus, which received Fast Track Designation from the FDA earlier this year. In Phase 2 clinical trials, LB1148 demonstrated statistically significant improvements in accelerating the time to return of postoperative bowel function in gastrointestinal and cardiovascular surgery, and early observations also point to a reduction in adhesions following GI surgery.
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 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 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 help patients with acute and chronic gastrointestinal complications stemming from post-operative digestive enzyme damage. Palisade Bio’s innovative lead asset LB1148, advancing towards Phase 3, is a protease inhibitor with the potential to both reduce abdominal adhesions and help restore bowel function following surgery. Positive data from Phase 2 trials of LB1148 demonstrated safety and tolerability as well as a statistically significant improvement in return to bowel function and decrease in 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 chronic disruption of 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 future clinical development of LB1148, plans to continue to strengthen patent protections for LB1148 and the potential for its therapies to address health conditions. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.