NTR-101 for Alcoholic Hepatitis

(PhoenixAH Trial)

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Nterica Bio inc

Must not be taking: Systemic corticosteroids

Disqualifiers: HIV, Pregnancy, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, NTR-101, to determine its safety for individuals with acute alcohol-associated hepatitis, a severe liver condition caused by heavy drinking. The study targets patients whose condition is linked to specific strains of the bacteria E. faecalis. Participants will receive varying doses of the drug to assess its tolerance and potential side effects. It is suitable for those diagnosed with acute alcoholic hepatitis who can stay in a clinic for a week and attend follow-ups over the next month. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking systemic corticosteroids, you may not be eligible to participate.

Is there any evidence suggesting that NTR-101 is likely to be safe for humans?

Research shows that NTR-101 is being tested for safety in people with acute alcohol-related hepatitis. Since this trial is in its early stages, researchers are still gathering safety information. At this point, they are mainly focused on how well participants handle this new treatment.

In trials like this, doctors closely monitor participants for any side effects or health issues. This ensures the treatment's safety for future use. Although specific safety data for NTR-101 is not yet available, the early stage of the study means the drug is still under evaluation for safety in humans. Participants in this trial will be monitored carefully to learn more about any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholic hepatitis?

NTR-101 is unique because it targets alcoholic hepatitis with a new approach. Unlike standard treatments like corticosteroids, which primarily aim to reduce inflammation, NTR-101 is being explored for its potential to directly modulate the immune response more precisely. Researchers are excited because this could mean fewer side effects and potentially more effective management of the condition. Plus, with multiple dosing options being tested, there's a chance to tailor the treatment to achieve the best outcomes for different patients.

What evidence suggests that NTR-101 might be an effective treatment for alcoholic hepatitis?

Research suggests that NTR-101 might help treat alcoholic hepatitis, particularly when certain types of E. faecalis bacteria are present. This drug targets these bacteria, which can worsen the liver condition. Although limited data exists on NTR-101's effectiveness in humans, the treatment aims to improve liver health by addressing this bacterial issue. Early studies on similar conditions have shown improvements in liver function, indicating possible benefits. Researchers continue to study the treatment to understand its safety and tolerability. Participants in this trial will receive one of four different doses of NTR-101 to evaluate its effectiveness and safety. ^{3 4 6 7 8}

Who Is on the Research Team?

Tarek Hassanein, MD

Principal Investigator

Southern California Research Center, inc

Are You a Good Fit for This Trial?

Adults aged 18-70 with acute alcohol-associated hepatitis, marked by specific disease markers and E. faecalis presence, can join this trial. They must consent to treatment, have a BMI of 20-40 kg/m2, and agree to use contraception. Excluded are those with positive drug screens, certain medication use, low platelets, high risk for alcohol withdrawal, other liver diseases or systemic illnesses that could interfere with the study.

Inclusion Criteria

Diagnostic definition of acute alcohol-associated hepatitis based on well established standard disease markers

Able to provide written informed consent (either from patient or patient's legally authorized representative)

Enterococcus faecalis testing

Exclusion Criteria

Positive urine drug screen

I am currently taking corticosteroids.

Platelet count below specified ranges

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive multiple ascending doses of NTR-101 daily for 7 days

7 days

Inpatient stay for 9 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

35 days

Weekly visits for checkups and tests

What Are the Treatments Tested in This Trial?

Interventions

• NTR-101

Trial Overview The trial tests NTR-101's safety in treating acute alcoholic hepatitis linked to E. faecalis bacteria strains. Participants will receive varying doses daily for a week while staying at the clinic and attend weekly follow-ups for over a month while keeping symptom diaries.

How Is the Trial Designed?

Group I: Cohort 1 Active Control 1 Intervention

Dose 1

Group II: Cohort 2 Active Control 1 Intervention

Dose 2

Group III: Cohort 3 Active Control 1 Intervention

Dose 3

Group IV: Cohort 4 Active Control 1 Intervention

Dose 4

Who Is Running the Clinical Trial?

Nterica Bio inc

Lead Sponsor

Trials

1

Recruited

10+

Southern California Research Center

Collaborator

Southern California Liver Centers

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

In a study of 254 patients with alcoholic liver disease, metadoxine significantly improved liver function markers (ALT, AST, GGT) after 6 weeks of treatment compared to placebo, especially in patients who stopped drinking, with an improvement rate of 82.8%.

The treatment was found to be safe, with a low adverse event rate of 1.6% in both the metadoxine and placebo groups, indicating that metadoxine is a viable option for managing alcoholic liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Capsule metadoxine in the treatment of alcoholic liver disease: a randomized, double-blind, placebo-controlled, multicenter study]. Mao, YM., Zeng, MD., Li, YM., et al.[2016]

Citations

1. withpower.com withpower.com/trial/phase-1-alcohol-associated-hepatitis-2-2025-8e1d5

NTR-101 for Alcoholic Hepatitis (PhoenixAH Trial) In a study of 254 patients with alcoholic liver disease, metadoxine significantly improved liver function markers (ALT, AST, GGT) after 6 weeks of treatment ...

2. app.trialscreen.org app.trialscreen.org/trials/phase-1-safety-tolerability-ntr-101-patients-acute-alcohol-associated-hepatitis-trial-nct06750588

A Phase 1 Study of NTR-101 in Acute Alcoholic Hepatitis A Phase 1 Study of NTR-101 in Acute Alcoholic Hepatitis. Evaluating the Safety and Tolerability of a Novel Oral Treatment for Acute Alcoholic Liver Disease.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29655837/

Outcomes of Early Liver Transplantation for Patients ... - PubMed We found that most patients survive for 1 year (94%) and 3 years (84%), similar to patients receiving liver transplants for other indications.

4. withpower.com withpower.com/clinical-trials/for-hepatitis-b?page=2

Top Hepatitis B Clinical Trials | Power The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated hepatitis ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3883924/

Alcoholic Hepatitis: Current challenges and future directions Alcoholic hepatitis is a distinct clinical syndrome amongst people with chronic and active alcohol abuse with a potential for 30–40% mortality at one month.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06750588

Safety and Tolerability of NTR-101 in Patients With Acute ... The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated ...

7. trial.medpath.com trial.medpath.com/clinical-trial/7acfdf408d895476/ntr-101-alcohol-hepatitis-safety

Safety and Tolerability of NTR-101 in Patients With Acute ... The goal of this clinical trial is to learn about the safety and tolerability of NTR-101 in adult participants suffering from acute alcohol-associated ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9840076/

Emerging Pharmacotherapies in Alcohol-Associated ... However, safety concerns have been raised as the previous large CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes) study proved a higher infection rate ...