Palisade Bio is Granted Fast Track Designation from the U.S. Food and Drug Administration for LB1148 for Accelerated Return of Bowel Function following GI Surgery

By: Palisade Bio, Inc. via GlobeNewswire

November 22, 2022 at 08:35 AM EST

Carlsbad, CA, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for avoidance of acute and chronic post-surgical complications following gastrointestinal (GI) surgery, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LB1148 for the acceleration of time to return of bowel function following surgery.

LB1148, is a broad-spectrum serine protease inhibitor which acts to neutralize digestive enzymes, with the potential to both reduce abdominal adhesions and accelerate the return of bowel function following gastrointestinal surgery. By inhibiting the activity of digestive proteases, the Company believes that LB1148 has the potential to reduce the formation of adhesions in GI tissues and potentially accelerate the time to the return of normal GI function.

“Receiving Fast Track designation represents an important regulatory milestone for the Company. Although our current focus is on our adhesions study, this designation provides what we believe is a key component to our future clinical and regulatory strategies as we continue to formulate next steps for studying the return of bowel function,” commented JD Finley, interim CEO of Palisade Bio.

Herbert B. Slade, MD, FAAAAI Chief Medical Officer of Palisade Bio added, “This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address return of bowel function.”

According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation is eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

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 which acts to neutralize digestive enzymes, potentially reducing intestinal damage. In clinical studies, LB1148 has demonstrated positive results in reducing the incidence, extent, and severity of post-surgical abdominal adhesions and potentially accelerating the time to return of postoperative bowel function LB1148 is currently being evaluated in a Phase 2 study to evaluate return of gastrointestinal function, post-operative ileus and intra-abdominal adhesions 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.

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: progress of studies, including opening additional clinical trial sites, timing of results or data, progress and completion of patient enrollment, including timing thereof and the Company’s co-development partner’s expectation to complete enrollment; regulatory progress and strategy, including potential registration and commercialization of LB1148; the extent of the cash runway; the closing of the underwritten public offering; and expected proceeds from financings. 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; the Company’s ability to achieve additional financing to fund future operations and the Company’s ability to comply with the continued listing requirements for Nasdaq. Additional risks and uncertainties can be found in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the SEC on November 14, 2022, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. 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