NTR-101 for Alcoholic Hepatitis

(PhoenixAH Trial)

Overseen By Kasey Seyer

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

12 Participants Needed

Trial Summary

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 NTR-101 safe for humans?

The safety of extended-release naltrexone (NTR-101) has been studied in people with alcohol use disorder, including those with liver disease. Research shows it is generally safe and does not cause liver damage, even in those with existing liver conditions. ^{1 2 3 4 5}

What is the purpose of this trial?

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 (AH). The drug is intended for use in the treatment of AH where the presence of specific strains of E. faecalis play a contributing role. The main questions it aims to answer are: Are multiple doses of NTR-101 in participants with acute AH safe and well tolerated? What medical problems do participants have when taking NTR-101? Researchers will administer the drug and monitor participants in an inpatient center. Participants will: Be administered multiple ascending dose frequencies of NTR-101 every day for 7 days. Stay in the clinic for 9 days (7 days of treatment) and present to clinic once every week for checkups and tests for 35 days. Keep a diary of their symptoms until the checkups and tests are completed.

Research Team

Tarek Hassanein, MD

Principal Investigator

Southern California Research Center, inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 Liver Centers

Collaborator

Trials

1

Recruited

10+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Hepatic safety of once-monthly injectable extended-release naltrexone administered to actively drinking alcoholics. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Extended-release Naltrexone Is Not Linked to Hepatotoxicity in Adults Experiencing Homelessness and Alcohol Use Disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Capsule metadoxine in the treatment of alcoholic liver disease: a randomized, double-blind, placebo-controlled, multicenter study]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Safety, Pharmacokinetics, and Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis. [2023]