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Bio89-100

BIO89-100, also known as Pegozafermin, is an investigational drug currently being studied in clinical trials for the treatment of Nonalcoholic Steatohepatitis (NASH). These trials aim to evaluate the safety, efficacy, and tolerability of BIO89-100 in patients with NASH, including those with compensated cirrhosis. The drug is administered through subcutaneous injections and shows potential in addressing various aspects of NASH, including liver health and metabolic factors.

Table of Contents

What is BIO89-100?

BIO89-100, also known as pegozafermin, is an investigational drug being studied for the treatment of a liver condition called nonalcoholic steatohepatitis (NASH)[1]. It is a new medication that is administered through subcutaneous injections, which means it is injected just under the skin[2].

What condition does BIO89-100 treat?

BIO89-100 is being developed to treat Nonalcoholic Steatohepatitis (NASH)[1][2]. NASH is a serious liver disease characterized by fat accumulation in the liver, inflammation, and liver cell damage. It can lead to scarring of the liver (fibrosis) and, in severe cases, cirrhosis. NASH is not caused by alcohol consumption but is often associated with obesity, diabetes, and high cholesterol levels.

How is BIO89-100 administered?

BIO89-100 is given as a subcutaneous injection. This means the medication is injected just under the skin, typically in areas with more fatty tissue like the abdomen or thigh[1][2]. The frequency of administration can vary:

  • Once weekly (QW) dosing
  • Once every two weeks (Q2W) dosing
The exact dosing schedule and amount will be determined based on the results of ongoing clinical trials.

Current Clinical Trials

There are currently two main clinical trials investigating BIO89-100:

  1. Pharmacokinetic (PK) Study: This is an open-label, single-dose study evaluating how BIO89-100 is processed in the body of patients with NASH and compensated cirrhosis (a less severe form of cirrhosis where the liver is damaged but still functioning)[1].
  2. Efficacy and Safety Study: This is a larger, randomized, double-blind, placebo-controlled study looking at the effectiveness, safety, and tolerability of BIO89-100 in patients with biopsy-confirmed NASH[2]. This study is testing different doses and dosing schedules of BIO89-100.
These trials will help researchers understand how well BIO89-100 works, how safe it is, and how patients tolerate the medication.

How is the effectiveness of BIO89-100 measured?

The effectiveness of BIO89-100 is being evaluated through several measures[2]:

  • Histological improvement: This involves examining liver tissue samples under a microscope to see if there’s a reduction in fat, inflammation, and scarring.
  • Fibrosis improvement: Researchers are looking for a decrease in liver scarring without worsening of NASH.
  • Changes in liver enzymes: Specifically, they’re monitoring levels of ALT (alanine transaminase), an enzyme that can indicate liver damage when elevated.
  • Improvements in fat content: This is measured using a special type of MRI called MRI-PDFF (Magnetic Resonance Imaging – Proton Density Fat Fraction).
  • Changes in blood markers: Including triglycerides, cholesterol levels, and other indicators of liver health and metabolic function.
These measures help determine if BIO89-100 is effectively treating NASH and improving overall liver health.

Safety and Tolerability

An important aspect of the clinical trials is to evaluate the safety and tolerability of BIO89-100[1][2]. This includes:

  • Monitoring the frequency and severity of side effects (adverse events)
  • Tracking any serious adverse events
  • Recording how many patients discontinue the treatment due to side effects
This information helps researchers understand the overall safety profile of BIO89-100 and determine if the benefits outweigh any potential risks.

Potential Benefits of BIO89-100

While the full results of the clinical trials are not yet available, BIO89-100 is being studied for its potential to[2]:

  • Resolve or improve NASH without worsening liver fibrosis
  • Decrease liver fibrosis without worsening NASH
  • Improve liver fat content
  • Lower levels of liver enzymes, indicating reduced liver damage
  • Improve blood lipid profiles (triglycerides, LDL cholesterol)
  • Potentially improve blood sugar control (as measured by HbA1c)
These potential benefits could make BIO89-100 a valuable treatment option for patients with NASH, a condition for which there are currently limited effective treatments available.

Aspect Details
Drug Name BIO89-100 (Pegozafermin)
Condition Studied Nonalcoholic Steatohepatitis (NASH)
Administration Method Subcutaneous Injection
Dosages Studied 15 mg once weekly, 30 mg once weekly, 44 mg once every 2 weeks
Primary Outcomes NASH resolution, Fibrosis improvement
Secondary Outcomes Changes in liver enzymes, lipid levels, body fat composition, and other metabolic markers
Study Designs Open-label, single-dose PK study; Randomized, double-blind, placebo-controlled study
Safety Monitoring Adverse events (AEs), Serious adverse events (SAEs)

FAQ

  • What is BIO89-100? BIO89-100, also known as Pegozafermin, is an investigational drug being studied for the treatment of Nonalcoholic Steatohepatitis (NASH). It is administered through subcutaneous injections.
  • What is the main purpose of the clinical trials involving BIO89-100? The main purpose of these trials is to evaluate the safety, efficacy, and tolerability of BIO89-100 in patients with NASH, including those with compensated cirrhosis.
  • How is BIO89-100 being tested in clinical trials? BIO89-100 is being tested in different dosages and frequencies, including 15 mg once weekly, 30 mg once weekly, and 44 mg once every 2 weeks. Some trials also compare it to a placebo.
  • What are some of the outcomes being measured in these trials? The trials are measuring various outcomes, including changes in liver health (such as fibrosis improvement and NASH resolution), changes in blood lipid levels, liver enzyme levels, and body fat composition.
  • Are there any known side effects of BIO89-100? The trials are designed to evaluate the safety and tolerability of BIO89-100. They are monitoring for adverse events (AEs) and serious adverse events (SAEs), but specific side effects are not mentioned in the provided information.

Ongoing Clinical Trials on Bio89-100

  • Study on the Effects of Pegozafermin for Patients with Nonalcoholic Steatohepatitis (NASH) and Fibrosis

    Recruiting

    1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia France Germany +4

  • Study of Pegozafermin Treatment for Patients with Liver Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

    Recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria France Germany Hungary Italy +3

  • Study on the Effects of Pegozafermin and Simvastatin for Patients with Severe High Triglycerides

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia France Germany +5

Glossary

  • NASH: NASH stands for Nonalcoholic Steatohepatitis. It is a type of liver disease characterized by inflammation and fat accumulation in the liver, not caused by alcohol consumption.
  • Compensated Cirrhosis: A stage of chronic liver disease where the liver is damaged but still able to perform its essential functions.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Subcutaneous Injection: A method of administering medication by injecting it into the layer of tissue between the skin and muscle.
  • Fibrosis: The formation of excess fibrous connective tissue in an organ, often as a result of injury or chronic inflammation.
  • Biopsy: A medical procedure where a small sample of tissue is taken from the body for examination.
  • ALT (Alanine Transaminase): An enzyme found primarily in the liver; elevated levels can indicate liver damage.
  • MRI-PDFF: Magnetic Resonance Imaging – Proton Density Fat Fraction, a non-invasive method to measure liver fat content.
  • HbA1c: Hemoglobin A1c, a blood test that measures average blood sugar levels over the past 2-3 months.
  • Adiponectin: A hormone involved in regulating glucose levels and fatty acid breakdown.

References

  1. https://clinicaltrials.gov/study/NCT05022693
  2. https://clinicaltrials.gov/study/NCT04929483