LB1148 for Bowel Resection

(PROFILE Trial)

No longer recruiting at 38 trial locations

Overseen By Torrie Magee

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Leading BioSciences, Inc

Must not be taking: Hormonal contraceptives, Alvimopan

Disqualifiers: Age, IBD, Seizure disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LB1148 to determine if it can improve recovery after bowel surgery. Specifically, the treatment aims to reduce post-operative ileus (when the bowel doesn't wake up after surgery) and prevent intra-abdominal adhesions (scar tissue that can cause complications). Participants will receive either LB1148 or a placebo (a look-alike with no active medicine). People scheduled for elective bowel resection surgery and a planned stoma takedown or another abdominal surgery within eight months may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot use certain medications like alvimopan or 4% icodextrin during the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that LB1148 is generally well-tolerated in patients undergoing bowel surgery. Research indicates that the most common side effects involve the digestive system, occurring in about 4.7% of patients using LB1148 compared to 3.2% of those given a placebo. Importantly, no serious side effects directly linked to the drug were reported. This suggests that LB1148 is relatively safe for humans, with most issues being minor and related to digestion. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LB1148 for bowel resection due to its novel mechanism of action. Unlike traditional treatments that primarily involve surgical techniques and supportive care, LB1148 is designed to protect the intestines by inhibiting digestive enzymes. This could potentially reduce complications and speed up recovery after surgery. By targeting these enzymes, LB1148 offers a fresh approach that might improve outcomes for patients undergoing bowel resection.

What evidence suggests that LB1148 might be an effective treatment for post-operative ileus and intra-abdominal adhesions?

This trial will compare LB1148 with a placebo to evaluate its effectiveness in speeding up the return of normal bowel function after surgery. Studies have shown that LB1148 can accelerate the recovery of gut function, with participants recovering faster than those who did not receive it. However, one study found that LB1148 did not reduce adhesions, which are bands of scar tissue that can form after surgery. Overall, research indicates that LB1148 could be effective for improving recovery after bowel surgeries. ^{1 2 3 4 6}

Who Is on the Research Team?

Mitch Jones, MD

Principal Investigator

CMO

Are You a Good Fit for This Trial?

Inclusion Criteria

Planned stoma takedown or other planned abdominal surgery within 8 months of the initial surgery.

Has been informed of the nature of the study (either the subject or their legal representative), agrees to its provisions, and has provided written informed consent.

Willing to perform and comply with all study procedures including attending clinic visit as scheduled and completion of a second surgery for stoma takedown or other abdominal surgery and to determine the presence of intra-abdominal adhesions.

Exclusion Criteria

Received any other investigational therapy within 4 weeks prior to Randomization

You need to have urgent surgery on your intestines.

American Society of Anesthesiologists (ASA) Class 4 or 5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LB1148 or placebo during and after elective bowel resection surgery to evaluate return of gastrointestinal function and reduction of post-operative ileus and intra-abdominal adhesions

Up to 14 days

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of intra-abdominal adhesions

Up to 8 months

What Are the Treatments Tested in This Trial?

Interventions

• LB1148
• Placebo

How Is the Trial Designed?

Group I: LB1148 Experimental Treatment 1 Intervention

Active

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Leading BioSciences, Inc

Lead Sponsor

Trials

3

Recruited

120+

Palisade Bio

Lead Sponsor

Trials

3

Recruited

230+

Citations

1. palisadebio.com palisadebio.com/palisade-bio-announces-topline-results-from-u-s-phase-2-profile-study-evaluating-lb1148-for-post-surgical-abdominal-adhesions/

Press Releases Topline data demonstrated that LB1148 did not achieve the primary endpoint of reducing adhesions in LB1148 treated patients (n=11) compared to ...

2. journals.lww.com journals.lww.com/journalacs/fulltext/2022/11002/lb1148__an_enteral_protease_inhibitor.35.aspx

LB1148: An Enteral Protease Inhibitor Significantly... The aim of this study was to determine if a novel enteral formulation of tranexamic acid, LB1148, could accelerate return of GI function in patients undergoing ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02836470

NCT02836470 | A Study to Evaluate LB1148 for Return of ... The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04100447

NCT04100447 | A Study to Evaluate the Safety, Tolerability ... The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of LB1148 in subjects undergoing elective bowel resection.

5. biospace.com biospace.com/palisade-bio-and-newsoara-announce-positive-topline-efficacy-results-from-phase-2-study-of-lb1148-demonstrating-accelerated-return-of-bowel-function-after-gastrointestinal-surgery

Palisade Bio and Newsoara Announce Positive Topline ... Further, LB1148 has now shown statistically significant acceleration of return of bowel function in a Phase 2 study for cardiovascular surgery ...

6. healio.com healio.com/news/gastroenterology/20230810/tranexamic-acid-flops-in-profile-trial-for-post-surgical-abdominal-adhesions

Tranexamic acid flops in PROFILE trial for post-surgical ... LB1148, an oral liquid formulation of tranexamic acid, failed to reduce abdominal adhesions following elective bowel resection.