Palisade Bio Receives FDA Fast Track Designation for LB1148 for Reduction of Adhesions Following Abdominal and Pelvic Surgery

Rhea-AI Summary

Palisade Bio, Inc. (Nasdaq: PALI) has received Fast Track Designation from the U.S. FDA for its investigational drug LB1148, aimed at reducing surgical adhesions after abdominal surgeries. This follows a prior designation for treating GI dysfunction in pediatric cardiovascular surgery patients.

LB1148 is designed to inhibit digestive proteases released during surgery, potentially addressing serious complications such as small bowel obstruction and chronic pain, which affect over 90% of post-abdominal surgery patients.

Positive

• LB1148's Fast Track Designation could expedite its development and review process.
• The drug has potential market implications as the first oral treatment for surgical adhesion reduction.
• Positive Phase 2 trial results indicated safety, tolerability, and significant improvement in bowel function.

Negative

• None.

LB1148 was previously granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of postoperative GI dysfunction associated with pediatric cardiovascular surgery

A Phase 2 gastrointestinal surgery trial that will evaluate LB1148 for reduction in adhesions is expected to read out data in 2021

CARLSBAD, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI), a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational drug LB1148, which has the potential to be the first oral treatment to reduce adhesions following abdominal or pelvic surgery. LB1148 was previously granted Fast Track Designation for the treatment of postoperative GI dysfunction associated with gut hypoperfusion injury in pediatric patients who have undergone congenital heart disease repair surgery in January 2021.

"Fast Track Designation represents another positive step for the clinical development of LB1148 and is a clear recognition of the serious need that exists for patients looking to avoid long-lasting and serious complications from post-surgical adhesions,” said Tom Hallam, Ph.D., chief executive officer of Palisade Bio. "We look forward to working closely with the FDA to maintain an open dialogue about the clinical path forward with LB1148, not only for the reduction of surgical adhesions indication, but also in the other post-op indications where it is being investigated in the clinic. We believe that by reducing adhesions, LB1148 has the potential to benefit patients, physicians, hospitals, and payers alike."

Under the FDA Modernization Act of 1997, designation as a Fast Track product means the FDA can take action to expedite both the development and the review of the application for approval.

About Adhesions
Adhesions are found in more than 90% of patients after intra-abdominal surgery. Adhesion-related complications such as small bowel obstruction (SBO), chronic pain and female infertility occur in up to 19% of abdominal surgery patients and are responsible for significant morbidity and mortality with an estimated annual economic impact of over $2.3 billion. A follow-up surgical procedure, called adhesiolysis, is often needed to resolve adhesion formation. Subsequent operations to remove adhesions or other abdominal surgeries are associated with inadvertent enterotomy rates of 10% to 20%, resulting in an estimated mortality of 13%. More than 70% of SBOs, and 40% of cases of infertility occur secondary to adhesions. SBOs are among the 10 most frequently performed emergency surgeries and account for up to 80% of emergency surgery-related deaths.

About LB1148
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 reduce 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, Inc.
Palisade Bio is a late-stage biopharma 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, is a Phase 3-ready 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 the potential for LB1148 to benefit patients and the potential for the FDA to expediate a future application for marketing approval of LB1148 for any indication. 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, related to the Palisade’s ability to advance its clinical development of LB1148, including the initiation, enrollment and completion of current and future clinical trials, and the uncertain and time-consuming regulatory approval process. Additional risks and uncertainties can be found in the Palisade’s Registration Statement on Form S-4 initially filed with the SEC on December 23, 2020, as amended (Registration No. 333-251659). 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.

Palisade Bio Media Relations Contact:
Darren Opland, Ph.D.
LifeSci Communications
darren@lifescicomms.com

Palisade Bio Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com

Corporate Contact:
Justin Stege, Ph.D.
justin.stege@palisadebio.com

Source: PalisadeBio

FAQ

What is the significance of Fast Track Designation for PALI's LB1148?

Fast Track Designation allows for expedited development and review of LB1148, potentially speeding up its availability to patients and impacting PALI's stock positively.

What complications does LB1148 aim to address?

LB1148 targets complications arising from abdominal and pelvic surgeries, particularly surgical adhesions, which can lead to small bowel obstruction and chronic pain.

What are the clinical trial results for LB1148?

Phase 2 trials for LB1148 demonstrated safety and a statistically significant improvement in return to bowel function compared to placebo.

When is the data readout for the Phase 2 gastrointestinal surgery trial?

Data from the Phase 2 gastrointestinal surgery trial evaluating LB1148 is expected to be available in 2021.

What market potential does LB1148 hold for Palisade Bio?

If successful, LB1148 could address a significant healthcare need, with an estimated annual economic impact of over $2.3 billion due to adhesion-related complications.