Humanised Igg1 Kappa Monoclonal Antibody Against Alfa4Beta7 Integrin

Recent clinical trials are investigating the potential of a novel drug called Humanised IgG1 Kappa Monoclonal Antibody Against Alpha4Beta7 Integrin, also known as ABBV-382. This medication is being studied for its efficacy in treating two distinct conditions: HIV in patients on stable antiretroviral therapy and moderate to severe Crohn’s disease. These trials aim to evaluate the drug’s safety, effectiveness, and how it works in the body, potentially offering new treatment options for patients with these challenging conditions.

What is ABBV-382?
How does ABBV-382 work?
Potential Uses of ABBV-382
Ongoing Clinical Trials
Eligibility Criteria for Clinical Trials
Safety and Side Effects
Future Prospects

What is ABBV-382?

ABBV-382 is a new medication currently being studied for its potential to treat various conditions, including HIV (Human Immunodeficiency Virus) and Crohn’s disease. It is classified as a humanised IgG1 kappa monoclonal antibody that targets a specific protein called alfa4beta7 integrin.^[1]^[2]

To break down this complex name:

Humanised: This means the antibody has been engineered to be similar to human antibodies, reducing the chance of the body rejecting it.
IgG1: This refers to a specific type of antibody that is commonly found in human blood.
Monoclonal antibody: This is a type of protein made in a laboratory that can bind to specific substances in the body, potentially helping to fight diseases.

How does ABBV-382 work?

ABBV-382 works by targeting and binding to a protein called alfa4beta7 integrin. This protein plays a role in how certain immune cells move through the body. By binding to this protein, ABBV-382 may be able to influence the immune system’s behavior, which could be beneficial in treating certain diseases.^[1]^[2]

The medication is administered as a solution for injection or infusion, which means it can be given either through a vein (intravenously) or under the skin (subcutaneously).^[2]

Potential Uses of ABBV-382

Based on ongoing clinical trials, ABBV-382 is being studied for its potential to treat two main conditions:

HIV (Human Immunodeficiency Virus): Researchers are investigating whether ABBV-382 can help control HIV in people who are already on stable antiretroviral therapy (ART). The goal is to see if it can keep HIV levels low even when patients temporarily stop their regular HIV medications.^[1]
Crohn’s Disease: This is a type of inflammatory bowel disease that causes inflammation in the digestive tract. ABBV-382 is being studied to see if it can help reduce inflammation and improve symptoms in people with moderate to severe Crohn’s disease.^[2]

Ongoing Clinical Trials

There are currently two main clinical trials studying ABBV-382:

HIV Study: This is a Phase 2 trial looking at the use of ABBV-382 (along with another drug called budigalimab) in people living with HIV who are on stable antiretroviral therapy. The study aims to see if these drugs can help control HIV levels when patients temporarily stop their regular HIV medications (a process called analytical treatment interruption).^[1]
Crohn’s Disease Study: This is also a Phase 2 trial, investigating the use of ABBV-382 (along with other drugs) in adults with moderate to severe Crohn’s disease. The study is looking at how safe and effective these treatments are, and how they affect the underlying mechanisms of the disease.^[2]

Eligibility Criteria for Clinical Trials

The eligibility criteria for participating in these clinical trials are quite specific. Here are some key points:

For the HIV study:^[1]

Participants must be between 18 and 70 years old
They must have been on HIV medication (antiretroviral therapy) for at least 12 months
Their HIV viral load must be undetectable, and their CD4+ T cell count (a measure of immune health) must be at least 500 cells/μL
They must not have had exposure to long-acting antiretrovirals within the past 24 weeks

For the Crohn’s disease study:^[2]

Participants must be between 18 and 75 years old
They must weigh at least 40 kg (about 88 pounds)
They must have had a diagnosis of Crohn’s disease for at least 3 months
Their disease must be moderate to severe, as measured by specific clinical and endoscopic scores
They must have shown an inadequate response or intolerance to certain other treatments for Crohn’s disease

Safety and Side Effects

As ABBV-382 is still in clinical trials, comprehensive information about its safety profile and potential side effects is not yet available. The ongoing studies are designed to evaluate the safety and tolerability of the drug, along with its effectiveness.^[1]^[2]

It’s important to note that all new medications can potentially cause side effects, and the full range of these may not be known until the drug has been studied in larger groups of people. Patients participating in clinical trials are closely monitored for any adverse effects.

Future Prospects

The development of ABBV-382 represents an exciting area of research in both HIV treatment and inflammatory bowel disease management. If successful, it could offer new options for patients who haven’t responded well to existing treatments.

For HIV, ABBV-382 could potentially contribute to strategies for long-term viral control, possibly reducing the need for daily medication in some patients.^[1]

In Crohn’s disease, ABBV-382 might offer a new approach to reducing inflammation and improving symptoms, particularly for patients who haven’t responded well to other treatments.^[2]

However, it’s important to remember that ABBV-382 is still in the early stages of clinical testing. More research is needed to fully understand its effectiveness and safety before it could potentially become available as a treatment option.

Aspect	HIV Trial	Crohn’s Disease Trial
Trial Phase	Phase 2	Phase 2a
Study Design	Randomized, Double-Blind, Placebo-controlled	Multicenter, Randomized, Platform Study
Main Objective	Evaluate efficacy, safety, tolerability, and PK of ABBV-382 in PLWH on stable ART undergoing ATI	Evaluate safety, efficacy, and mechanistic profile of targeted therapies including ABBV-382
Primary Endpoint	Viral control at Week 24 without ART restart	Achievement of endoscopic remission at Week 12
Key Inclusion Criteria	PLWH 18-70 years old, on ART for ≥12 months, CD4+ count ≥500 cells/μL	Adults 18-75 years old, confirmed Crohn’s disease diagnosis, CDAI ≥220, SES-CD ≥6 (or ≥4 for isolated ileal disease)
Key Exclusion Criteria	Prior exposure to long-acting antiretrovirals, CD4+ nadir ≤200 cells/μL	Intolerance to p19 inhibitors, current diagnosis of UC or indeterminate colitis
Drug Administration	Solution for injection/infusion	Solution for injection/infusion (intravenous/subcutaneous/intramuscular)

Aspect

HIV Trial

Crohn’s Disease Trial

Trial Phase

Phase 2

Phase 2a

Study Design

Randomized, Double-Blind, Placebo-controlled

Multicenter, Randomized, Platform Study

Main Objective

Evaluate efficacy, safety, tolerability, and PK of ABBV-382 in PLWH on stable ART undergoing ATI

Evaluate safety, efficacy, and mechanistic profile of targeted therapies including ABBV-382

Primary Endpoint

Viral control at Week 24 without ART restart

Achievement of endoscopic remission at Week 12

Key Inclusion Criteria

PLWH 18-70 years old, on ART for ≥12 months, CD4+ count ≥500 cells/μL

Adults 18-75 years old, confirmed Crohn’s disease diagnosis, CDAI ≥220, SES-CD ≥6 (or ≥4 for isolated ileal disease)

Key Exclusion Criteria

Prior exposure to long-acting antiretrovirals, CD4+ nadir ≤200 cells/μL

Intolerance to p19 inhibitors, current diagnosis of UC or indeterminate colitis

Drug Administration

Solution for injection/infusion

Solution for injection/infusion (intravenous/subcutaneous/intramuscular)

Ongoing Clinical Trials on Humanised Igg1 Kappa Monoclonal Antibody Against Alfa4Beta7 Integrin

Glossary

Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. It is designed to target and interact with a specific part of a cell or other target in the body.
Alpha4Beta7 Integrin: A protein on the surface of certain immune cells that helps these cells move into the gut. It is involved in gut inflammation and is a target for some treatments for inflammatory bowel diseases and potentially HIV.
Antiretroviral Therapy (ART): A combination of medications used to treat HIV infection. It works by preventing the virus from multiplying in the body.
Analytical Treatment Interruption (ATI): A planned pause in antiretroviral therapy for HIV patients, usually done in a controlled setting to study the effects of new treatments or the body's response to the virus.
Crohn's Disease: A type of inflammatory bowel disease that causes inflammation of the digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition.
Endoscopic Remission: A state in which an examination of the inside of the digestive tract using an endoscope shows no signs of active disease or inflammation.
Viral Load: The amount of HIV in a person's blood. A main goal of HIV treatment is to reduce viral load to undetectable levels.
CD4+ T Cell Count: A measure of the number of CD4 T lymphocytes (a type of white blood cell) in the blood, which is an important indicator of immune system health in people with HIV.
CDAI (Crohn's Disease Activity Index): A tool used to measure the severity of Crohn's disease symptoms and to assess the effectiveness of treatments.
SES-CD (Simple Endoscopic Score for Crohn's Disease): A scoring system used to assess the severity of Crohn's disease based on findings during an endoscopic examination of the intestines.

References

http://clinicaltrials.eu/trial/study-on-budigalimab-and-abbv-382-for-people-with-hiv-on-stable-antiretroviral-therapy/
http://clinicaltrials.eu/trial/study-of-lutikizumab-abbv-382-and-risankizumab-for-adults-with-moderate-to-severe-crohns-disease/

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