LB-P8 for Primary Sclerosing Cholangitis

Recruiting at 6 trial locations

Overseen By LISCure Biosciences Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: LISCure Biosciences

Must not be taking: Antibiotics, Rebyota, Vowst

Disqualifiers: Liver transplant, Cirrhosis, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

87 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LB-P8 for individuals with primary sclerosing cholangitis (PSC), a liver disease that damages bile ducts. Researchers aim to determine the safety and effectiveness of LB-P8. Participants will receive either a low dose, a high dose, or a placebo (inactive substance) to compare outcomes. Those with PSC who also have stable inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, and are not using probiotics might be suitable for the trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that if you are taking certain medications like biologics, immunosuppressants, corticosteroids, obeticholic acid, fibrates, or statins, you must be on a stable dose for at least 3 months before and during the study. You will need to stop taking probiotics at least 2 weeks before starting the treatment.

Is there any evidence suggesting that LB-P8 is likely to be safe for humans?

Research has shown that LB-P8 has been safe in earlier studies. Tests on animals and initial human trials indicate that people generally tolerate LB-P8 well. These studies also suggest it might help with inflammatory conditions. In earlier phases, researchers found no major safety issues, which is promising for ongoing research. While LB-P8 is still under study, past tests with humans have shown it to be safe. This ongoing trial will closely monitor safety to confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for primary sclerosing cholangitis?

Most treatments for primary sclerosing cholangitis (PSC) focus on managing symptoms with medications like ursodeoxycholic acid, but LB-P8 offers a new approach. LB-P8 is unique because it utilizes probiotics in the form of oral capsules, aiming to modulate the gut microbiome, which may play a role in PSC. Researchers are excited about LB-P8 because it is offered in both low-dose and high-dose options, potentially allowing for tailored treatment strategies. This probiotic approach could represent a gentler and more targeted strategy compared to traditional therapies, potentially improving liver health from within.

What evidence suggests that LB-P8 might be an effective treatment for primary sclerosing cholangitis?

Research suggests that LB-P8 might help treat primary sclerosing cholangitis (PSC). In studies with mice, a four-week regimen of LB-P8 reduced inflammation and scarring related to this disease. LB-P8 has also shown benefits for inflammatory bowel disease (IBD), which often occurs with PSC. These findings indicate that LB-P8 could help lower inflammation associated with PSC. While research in humans is ongoing, these early results are promising for LB-P8 as a potential treatment. Participants in this trial will receive either a low dose or high dose of LB-P8, or a placebo, to further evaluate its effectiveness in treating PSC. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with a liver condition called primary sclerosing cholangitis (PSC). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of PSC.

Inclusion Criteria

ALP >1.5 times the ULN at screening

PSC with or without IBD

Inability to conceive or use effective contraception

Exclusion Criteria

I have been diagnosed with small-duct primary sclerosing cholangitis.

My ulcerative colitis or Crohn's disease has a specific severity score.

Treatment with investigational agents within specified timeframe

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Evaluation of safety and tolerability of 2 pre-selected dose levels of LB-P8 in adult patients with PSC

4 weeks

Treatment Part 2

Evaluation of safety and efficacy in adult patients with PSC, randomized to receive low-dose LB-P8, high-dose LB-P8, or placebo

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LB-P8

Trial Overview

The study is testing the safety and effectiveness of LB-P8 at two different doses compared to a placebo. Participants will be randomly assigned to receive either a low dose of LB-P8, a high dose of LB-P8, or a placebo.

How Is the Trial Designed?

Group I: LB-P8 low-dose Experimental Treatment 1 Intervention

Oral capsule, 1×10\^10 CFU/day

Group II: LB-P8 high-dose Experimental Treatment 1 Intervention

Oral capsule, 1×10\^11 CFU/day

Group III: Placebo Placebo Group 1 Intervention

Oral capsule, placebo

Who Is Running the Clinical Trial?

LISCure Biosciences

Lead Sponsor

Trials

2

Recruited

120+

Published Research Related to This Trial

Primary sclerosing cholangitis (PSC) is a progressive liver disease with no effective treatments currently available, and it often leads to serious complications like cirrhosis and bile duct cancer over a long period, typically a decade or more.

Management of PSC focuses on symptom relief and addressing complications, with options like balloon dilatation for strictures and liver transplantation for advanced cases, while experimental therapies such as immunosuppressive and choleretic agents are being tested in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fifth Carlos E. Rubio Memorial Lecture. Sclerosing cholangitis: pathogenesis, pathology, and practice. Larusso, NF.[2018]

In a study of 21 patients with primary sclerosing cholangitis (PSC) treated with 9 mg of oral budesonide daily for one year, there was a slight improvement in liver enzyme levels, but overall benefits were minimal.

The treatment was associated with significant bone mass loss, indicating a risk of osteoporosis, and two patients required evaluation for liver transplantation, suggesting potential safety concerns with budesonide in PSC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral budesonide in the treatment of primary sclerosing cholangitis. Angulo, P., Batts, KP., Jorgensen, RA., et al.[2015]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06699121

A Study to Assess the Safety and Efficacy of LB-P8 in ...

This is phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of LB-P8 in adult patients with primary ...

2.

finance.yahoo.com

finance.yahoo.com/news/liscure-biosciences-initiates-global-phase-120000882.html

LISCure Biosciences Initiates Global Phase 2 Trial of LB- ...

Moreover, LB-P8 has shown therapeutic effects in inflammatory bowel disease (IBD), which coexists in approximately 80% of PSC patients, giving ...

3.

liverdiseasenews.com

liverdiseasenews.com/news/phase-2-study-lb-pp8-primary-sclerosing-cholangitis-cleared-fda/

Phase 2 study of LB-P8 for PSC nets FDA clearance

Preclinical data showed administering LB-P8 orally for four weeks after the onset of disease eased inflammation and scarring in two mouse models ...

4.

allclinicaltrials.com

allclinicaltrials.com/study/NCT06699121

A Study to Assess the Safety and Efficacy of LB-P8 in ...

The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis. .

5.

aasld.org

aasld.org/the-liver-meeting/microbial-monotherapy-leuconostoc-sp-lb-p8-improves-inflammation-and-fibrosis

MICROBIAL MONOTHERAPY WITH LEUCONOSTOC SP. ...

LB-P8 IMPROVES INFLAMMATION AND FIBROSIS IN MOUSE MODELS OF PRIMARY SCLEROSING CHOLANGITIS. ... These data suggest that LB-P8 targeting of the gut-liver ...

6.

biopharmaboardroom.com

biopharmaboardroom.com/news/18/3995/liscure-biosciences-initiates-global-phase-2-trial-of-lb-p8-in-primary-sclerosing-cholangitis.html

LISCure Biosciences Initiates Global Phase 2 Trial of LB- ...

Preclinical and Phase 1 studies have demonstrated its safety and initial efficacy. Moreover, LB-P8 has shown therapeutic effects in inflammatory bowel disease ( ...

7.

go.drugbank.com

go.drugbank.com/drugs/DB18535/clinical_trials?conditions=DBCOND0048258&phase=2&purpose=treatment&status=recruiting

LB-P8 Recruiting Phase 2 Trials for Primary Sclerosing ...

LB-P8 Recruiting Phase 2 Trials for Primary Sclerosing Cholangitis (PSC) Treatment ... A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC.