What is the mechanism of action of this treatment?

Asthma treatments primarily work by reducing inflammation and relaxing airway muscles to improve breathing. Inhaled corticosteroids (ICS) reduce airway inflammation, preventing exacerbations. Long-acting beta agonists (LABAs) relax airway smooth muscles, improving airflow and reducing symptoms. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction. Monoclonal antibodies target specific immune pathways to reduce severe asthma symptoms. Verekitug (UPB-101) likely modulates pathways involved in asthma exacerbations and control, offering a targeted approach to managing severe asthma. These mechanisms are crucial for asthma patients as they help maintain open airways, reduce symptoms, and prevent severe attacks, improving overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for asthma, such as inhaled glucocorticoids, LABAs, leukotriene modifiers, and biologics like mepolizumab, have various side effects. Inhaled glucocorticoids can cause oral thrush, hoarseness, and, rarely, systemic effects like adrenal suppression. LABAs may lead to tremors, palpitations, and, in some cases, increased risk of asthma-related hospitalization. Leukotriene modifiers can cause headaches, gastrointestinal disturbances, and neuropsychiatric events. Biologics like mepolizumab may result in injection site reactions, headaches, and, rarely, hypersensitivity reactions. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of asthma, particularly those targeting pathways involved in asthma exacerbations and control. These include biological agents such as mepolizumab, benralizumab, dupilumab, and omalizumab, which target specific inflammatory pathways and cytokines involved in severe asthma. Mepolizumab and benralizumab target IL-5, reducing eosinophilic inflammation, while dupilumab targets IL-4 and IL-13 pathways. Omalizumab is an anti-IgE antibody used for allergic asthma. These treatments have shown efficacy in reducing asthma exacerbations and improving lung function and asthma control.

What other types of research exist?

Promising novel alternatives to Verekitug (UPB-101) for asthma treatment include Mepolizumab and Itepekimab. Mepolizumab is a monoclonal antibody that targets IL-5, reducing eosinophilic inflammation and asthma exacerbations. Itepekimab targets IL-33, reducing airway inflammation and associated tissue damage. Both have shown efficacy in improving asthma control and reducing exacerbations.

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Verekitug for Severe Asthma

Phase 2

Recruiting

Research Sponsored by Upstream Bio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months.

Documented history of asthma exacerbation(s) within 12 months of Visit 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 64

Summary

This trial tests a new injectable medication, verekitug (UPB-101), on adults with severe asthma to see if it can reduce asthma attacks and improve breathing.

Who is the study for?

This trial is for adults aged 18-75 with severe asthma, who've had an exacerbation in the past year and are on medium to high dose inhalers plus another controller medication. They must have a certain level of asthma control and lung function, agree to use contraception, and be able to follow the study's procedures.

What is being tested?

The VALIANT study tests Verekitug (UPB-101) against a placebo in severe asthma patients. It measures how well it prevents worsening of symptoms, improves lung function and overall control of asthma compared to not receiving the active drug.

What are the potential side effects?

While specific side effects aren't listed here, typical ones may include reactions at injection sites, headaches, fatigue or allergic responses. The safety profile will compare any adverse effects experienced with Verekitug versus those observed with a placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on medium or high dose asthma inhalers for 3 months, and if on a medium dose, I've also used another asthma control medicine.

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I have had an asthma attack in the last year.

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I am between 18 and 75 years old.

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I have been diagnosed with asthma for over a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 64 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annual Asthma Exacerbation Rate (AAER)

Secondary study objectives

Change from Baseline in Asthma Control Questionnaire-6 (ACQ-6) to Week 60

Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) to Week 60

Change from Baseline in Fractional exhaled nitric oxide (FeNO) to Week 60

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Verekitug (UPB-101): 400 mg Q24W / PlaceboExperimental Treatment2 Interventions

Participants will receive 2.0 mL of verekitug (UPB-101) formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.

Group II: Verekitug (UPB-101): 100 mg Q24W / PlaceboExperimental Treatment2 Interventions

Participants will receive 0.5 mL of verekitug (UPB-101) formulated solution (containing 100 mg of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits.

Group III: Verekitug (UPB-101): 100 mg Q12W / PlaceboExperimental Treatment2 Interventions

Participants will receive 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 12 weeks up to Week 48.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 48.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Asthma treatments primarily work by reducing inflammation and relaxing airway muscles to improve breathing. Inhaled corticosteroids (ICS) reduce airway inflammation, preventing exacerbations. Long-acting beta agonists (LABAs) relax airway smooth muscles, improving airflow and reducing symptoms. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction. Monoclonal antibodies target specific immune pathways to reduce severe asthma symptoms. Verekitug (UPB-101) likely modulates pathways involved in asthma exacerbations and control, offering a targeted approach to managing severe asthma. These mechanisms are crucial for asthma patients as they help maintain open airways, reduce symptoms, and prevent severe attacks, improving overall quality of life.

Beta 2 agonist therapy: oral versus inhaled delivery.Ultra Long-Acting β-Agonists in Chronic Obstructive Pulmonary Disease.New pharmacological treatments for patients with chronic obstructive pulmonary disease (COPD).