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Human Glucagon-Like Peptide-2 Analogue Linked To A Human Immunoglobulin Fc Fragment

This article explores the ongoing clinical trials of HM15912, a novel drug designed to treat Short Bowel Syndrome-associated Intestinal Failure (SBS-IF). HM15912 is a human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment, currently being studied in a Phase 2 clinical trial. The research aims to evaluate the safety, tolerability, and effectiveness of this innovative treatment for patients struggling with SBS-IF.

Table of Contents

What is HM15912?

HM15912 is a new medication being studied for the treatment of Short Bowel Syndrome-associated Intestinal Failure (SBS-IF). It is classified as a human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment. This means it’s a modified version of a naturally occurring hormone in our body, designed to last longer and potentially work better[1].

What is Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)?

Short Bowel Syndrome (SBS) is a condition where a large portion of the small intestine is missing or has been surgically removed. This can lead to Intestinal Failure (IF), which means the intestines can’t absorb enough nutrients and fluids to maintain health. People with SBS-IF often need to receive nutrition and fluids through intravenous (IV) methods, a process called parenteral nutrition (PN)[1].

How HM15912 Works

HM15912 is designed to mimic the action of GLP-2 (glucagon-like peptide-2), a hormone that naturally occurs in the body and helps improve intestinal function. By linking this GLP-2 analogue to a part of an antibody (the Fc fragment), researchers hope to make the medication last longer in the body, potentially requiring less frequent dosing[1].

Current Research on HM15912

A clinical trial called DOLPHINS-2 is currently underway to study HM15912. This is a Phase 2 study, which means it’s testing the drug’s effectiveness and safety in a larger group of people with SBS-IF. The study will last 24 weeks and involve multiple doses given by subcutaneous injection (an injection under the skin)[1].

Who Can Participate in the Study?

The study is looking for adults (18 years or older) with SBS-IF. Here are some key eligibility criteria:

  • Diagnosed with SBS-IF for at least 6 months
  • Stable need for parenteral nutrition/intravenous fluids
  • Body weight of 30 kg or more and BMI greater than 18 kg/m²
  • No history of colon cancer
  • No active, uncontrolled systemic diseases
  • Not pregnant or breastfeeding

There are additional specific criteria that the study doctors will use to determine if someone is eligible to participate[1].

Study Objectives and Endpoints

The main goals of the study are:

  1. To assess the safety and tolerability of HM15912
  2. To understand how the drug moves through and is processed by the body (pharmacokinetics)
  3. To evaluate how the drug affects the body (pharmacodynamics)

The researchers will look at things like:

  • The occurrence of side effects
  • How the injection site reacts
  • Changes in lab tests, physical exams, and vital signs
  • How much of the drug is in the blood at different times
  • Changes in the amount of parenteral nutrition needed

These measurements will help determine if HM15912 is safe and effective for treating SBS-IF[1].

Safety Considerations

As with any new medication, safety is a top priority. The study will carefully monitor participants for any side effects or adverse reactions. Some specific safety considerations include:

  • Monitoring for injection site reactions
  • Regular check-ups and lab tests
  • Screening for any pre-existing conditions that might increase risks
  • Careful tracking of any changes in parenteral nutrition needs

It’s important to note that HM15912 is still in the research phase, and its full safety profile is not yet known. The purpose of this study is to gather more information about its safety and effectiveness[1].

Aspect Details
Drug Name HM15912
Drug Type Human Glucagon-Like Peptide-2 Analogue Linked to a Human Immunoglobulin Fc Fragment
Condition Treated Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
Trial Phase Phase 2
Administration Method Subcutaneous injection
Primary Objectives 1. Assess safety and tolerability
2. Evaluate pharmacokinetic profile
Secondary Objective Assess pharmacodynamic profile
Key Inclusion Criteria 1. Adults with SBS-IF
2. Stable parenteral nutrition needs
3. No planned restorative surgery
Key Exclusion Criteria 1. History of colon cancer
2. Certain medical conditions (e.g., radiation enteritis, celiac disease)
3. Recent use of specific medications
Primary Endpoints 1. Incidence of adverse events
2. Changes in laboratory values, vital signs, and ECG parameters
3. Various pharmacokinetic measures (e.g., Cmax, t1/2, AUC)
Secondary Endpoint Change in weekly parenteral nutrition volume from baseline to Week 25

FAQ

  • What is HM15912? HM15912 is a new drug being tested for Short Bowel Syndrome-associated Intestinal Failure (SBS-IF). It's a human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment, designed to help patients with this condition.
  • What is the main goal of the clinical trial for HM15912? The main goals of the clinical trial are to assess the safety and tolerability of HM15912 when given as multiple subcutaneous doses over 24 weeks, and to study how the drug behaves in the body (its pharmacokinetics).
  • Who can participate in this clinical trial? The trial is open to adults (18 years or older) with Short Bowel Syndrome resulting in intestinal failure. Participants must meet specific criteria, including stable parenteral nutrition needs and no plans for restorative surgery during the study period.
  • How is HM15912 administered in the trial? HM15912 is administered through subcutaneous injection, which means it's injected just under the skin. The exact dosing schedule and amounts are being studied as part of the trial.
  • What are the potential benefits of HM15912 for SBS-IF patients? While the benefits are still being studied, the researchers hope that HM15912 might help reduce the need for parenteral nutrition in SBS-IF patients. One of the secondary endpoints of the study is to measure changes in weekly parenteral nutrition volume from the start to the end of the trial.

Ongoing Clinical Trials on Human Glucagon-Like Peptide-2 Analogue Linked To A Human Immunoglobulin Fc Fragment

  • Study of HM15912 for Adults with Short Bowel Syndrome-associated Intestinal Failure

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Germany Poland

Glossary

  • Short Bowel Syndrome-associated Intestinal Failure (SBS-IF): A condition where the body can't absorb enough nutrients due to a significant loss of small intestine function, often requiring intravenous nutrition support.
  • Glucagon-Like Peptide-2 (GLP-2): A hormone that helps improve intestinal function and nutrient absorption. HM15912 is an analogue, or modified version, of this hormone.
  • Parenteral Nutrition (PN): A method of feeding that bypasses the digestive system and delivers fluids and nutrients directly into the bloodstream.
  • Subcutaneous Injection: A way of giving medication by injecting it just under the skin.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • Phase 2 Clinical Trial: A stage of drug testing that focuses on evaluating the effectiveness and side effects of a new treatment in a larger group of patients.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during the use of a medical treatment, whether or not it is caused by the treatment.
  • Immunoglobulin Fc Fragment: A part of an antibody that can help increase the time a drug stays in the body, potentially allowing for less frequent dosing.
  • Jejunostomy: A surgical opening made in the jejunum (part of the small intestine) to allow nutrition to be delivered directly or to create an artificial opening for waste to leave the body.
  • Ileostomy: A surgical opening made in the ileum (the final part of the small intestine) to allow waste to leave the body.

References

  1. http://clinicaltrials.eu/trial/study-of-hm15912-for-adults-with-short-bowel-syndrome-associated-intestinal-failure/