Last updated: January 6, 2025
Introduction to LB1148
LB1148, developed by Palisade Bio, is a novel oral liquid formulation of the well-characterized digestive enzyme inhibitor tranexamic acid (TXA), acting as a broad-spectrum serine protease inhibitor. This drug candidate is designed to address significant post-surgical complications, particularly in the gastrointestinal (GI) sector.
Mechanism of Action
LB1148 works by inhibiting the activity of digestive proteases released from the gut during surgery. These proteases contribute to the temporary loss of normal GI function and the formation of postoperative adhesions. By neutralizing these enzymes, LB1148 aims to prevent damage to GI tissues, accelerate the return of normal GI function, and reduce the incidence and severity of post-surgical abdominal adhesions[1][3][4].
Clinical Trials and Development Status
Phase 2 Studies
LB1148 is currently being evaluated in a U.S. Phase 2 study, known as the PROFILE study, to assess its effectiveness in reducing intra-abdominal adhesions, accelerating the return of gastrointestinal function, and preventing post-operative ileus in patients undergoing elective bowel resection. This study has shown positive results in prior clinical trials, demonstrating the potential to reduce the time to return of postoperative bowel function and decrease the incidence and severity of post-surgical abdominal adhesions[2][4].
Dose Optimization Study
In addition to the PROFILE study, Palisade Bio is conducting a dose optimization study for LB1148. This study has already dosed eight patients and is expected to provide topline data in the third quarter of 2023. The dose optimization is crucial for refining the therapeutic regimen and ensuring the optimal efficacy and safety of LB1148[2].
Phase 3 Trials
A Phase 3 clinical trial for LB1148 is underway in China, conducted and funded by Newsoara Biopharma Co. Ltd. This multi-centered, randomized, double-blinded, placebo-controlled trial aims to assess the safety and efficacy of LB1148 in accelerating the return of bowel function following abdominal surgery. The enrollment of the first patient marks a significant milestone in the advancement of LB1148 toward potential FDA approval[4].
Market Projections and Opportunities
GI Health Market
The GI health market is projected to reach $59.8 billion by 2025, presenting a substantial opportunity for the successful deployment of LB1148 and similar products. The growing demand for effective treatments to mitigate post-surgical complications positions LB1148 as a potentially transformative solution in the healthcare sector[5].
Target Indications
LB1148 primarily targets two critical post-surgical complications:
- Post-surgical adhesions: Fibrous bands that can form between tissues and organs post-surgery, leading to pain and additional treatment requirements.
- Ileus: A condition characterized by a lack of movement in the intestines, causing a buildup of contents that can lead to significant distress[5].
By addressing these complications, LB1148 has the potential to improve patient outcomes, reduce hospital stays, and lower healthcare costs associated with post-surgical care.
Expert Insights and Future Outlook
According to J.D. Finley, interim Chief Executive Officer of Palisade Bio, "We continue to believe there is great potential for LB1148 to fundamentally transform the way physicians mitigate the risks of acute and chronic GI complications from surgery."[2]
Dr. Benny Li, Newsoara’s Chief Executive Officer, also emphasized the potential of LB1148, stating, "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."[4]
Key Takeaways
- Mechanism of Action: LB1148 inhibits digestive proteases to prevent GI tissue damage and reduce post-surgical adhesions.
- Clinical Trials: Currently in Phase 2 and Phase 3 trials to evaluate its efficacy in reducing intra-abdominal adhesions and accelerating GI function.
- Market Potential: Significant opportunity in the GI health market, projected to reach $59.8 billion by 2025.
- Target Indications: Post-surgical adhesions and ileus.
- Future Outlook: Potential to transform post-surgical care by improving patient outcomes and reducing healthcare costs.
FAQs
What is LB1148 and how does it work?
LB1148 is a broad-spectrum serine protease inhibitor that works by neutralizing digestive enzymes released during surgery, thereby preventing damage to GI tissues and reducing post-surgical adhesions.
What are the primary targets of LB1148?
The primary targets of LB1148 are post-surgical adhesions and ileus, conditions that significantly impact patient recovery and quality of life.
What is the current development stage of LB1148?
LB1148 is currently in Phase 2 and Phase 3 clinical trials to evaluate its efficacy and safety in various surgical indications.
How does LB1148 impact the GI health market?
LB1148 has the potential to significantly impact the GI health market, which is projected to reach $59.8 billion by 2025, by offering a transformative solution for post-surgical complications.
What are the expected outcomes of the ongoing clinical trials for LB1148?
The ongoing clinical trials aim to provide topline data on the effectiveness of LB1148 in reducing intra-abdominal adhesions, accelerating the return of gastrointestinal function, and preventing post-operative ileus. Positive outcomes could pave the way for FDA approval and widespread adoption.
Who is conducting the Phase 3 trial for LB1148 in China?
The Phase 3 trial for LB1148 in China is being conducted and funded by Newsoara Biopharma Co. Ltd.
Sources
- Palisade Bio Releases In-Depth Explanation of Scientific Approach of Lead Product Candidate LB1148 Through Animated Video. Palisade Bio.
- Palisade Bio's LB1148 Two Ongoing Clinical Trials Expecting Tipline Data Readouts. Palisade Bio.
- Leading BioSciences and Seneca Biopharma Announce Merger. Palisade Bio.
- Palisade Bio Announces Enrollment of First Patient in Newsoara Phase 3 Clinical Trial Evaluating LB1148. Palisade Bio.
- Marketing Mix Analysis of Palisade Bio, Inc. (PALI). dcf.fm.
