CLINICAL TRIALS PROFILE FOR FASENRA

All Clinical Trials for FASENRA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03733535 ↗	Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI	Active, not recruiting	AstraZeneca	N/A	2019-03-01	The purpose of this study is to evaluate the effect of a drug called benralizumab in individuals with severe, poorly controlled asthma with eosinophilic airway inflammation. Eosinophils are a type of white blood cell that help fight off infections. Some people with asthma have too many eosinophils in their airways and blood, which can cause airway inflammation. Benralizumab is a new drug that is Health Canada approved and has been shown to rapidly eliminate eosinophils. It has been used in patients with severe asthma to improve lung function and reduce flair-ups, also known as exacerbations. Magnetic Resonance Imaging (MRI) is an imaging tool that can look at the structure of the lungs when a subject inhales a xenon gas mixture. In healthy individuals, the gas fills the lungs evenly, but in individuals with lung disease, some of the areas of the lungs are not filled by the gas and the image looks patchy. These patchy areas are called ventilation defects and they contribute to reduced lung function. The goal of the study is to see if treatment with benralizumab will improve these ventilation defects, overall lung function and blood and sputum eosinophil levels. Subjects will receive treatment with benralizumab a total of 3 times, 4 weeks apart. Before and after treatment, subjects will undergo a series of MRI tests, breathing tests, blood and sputum analysis and a series of questionnaires to evaluate daily quality of life. The hypothesis is that ventilation defects will significantly improve after benralizumab treatment, and that this improvement will be different based on how long the patient has had asthma.
NCT03733535 ↗	Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI	Active, not recruiting	Dr. Grace Parraga	N/A	2019-03-01	The purpose of this study is to evaluate the effect of a drug called benralizumab in individuals with severe, poorly controlled asthma with eosinophilic airway inflammation. Eosinophils are a type of white blood cell that help fight off infections. Some people with asthma have too many eosinophils in their airways and blood, which can cause airway inflammation. Benralizumab is a new drug that is Health Canada approved and has been shown to rapidly eliminate eosinophils. It has been used in patients with severe asthma to improve lung function and reduce flair-ups, also known as exacerbations. Magnetic Resonance Imaging (MRI) is an imaging tool that can look at the structure of the lungs when a subject inhales a xenon gas mixture. In healthy individuals, the gas fills the lungs evenly, but in individuals with lung disease, some of the areas of the lungs are not filled by the gas and the image looks patchy. These patchy areas are called ventilation defects and they contribute to reduced lung function. The goal of the study is to see if treatment with benralizumab will improve these ventilation defects, overall lung function and blood and sputum eosinophil levels. Subjects will receive treatment with benralizumab a total of 3 times, 4 weeks apart. Before and after treatment, subjects will undergo a series of MRI tests, breathing tests, blood and sputum analysis and a series of questionnaires to evaluate daily quality of life. The hypothesis is that ventilation defects will significantly improve after benralizumab treatment, and that this improvement will be different based on how long the patient has had asthma.
NCT03450083 ↗	Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis	Completed	Johns Hopkins University	Phase 2	2017-07-01	Benralizumab will be used in a placebo controlled randomized study to treat severe chronic rhinosinusitis with nasal polyps

Clinical Trial Conditions for FASENRA

Condition Name

Condition Name for FASENRA
Intervention	Trials
Asthma	3
Nasal Polyps	1
Severe Eosinophilic Asthma	1

Condition MeSH

Condition MeSH for FASENRA
Intervention	Trials
Asthma	3
Pulmonary Eosinophilia	2
Sinusitis	1

Clinical Trial Locations for FASENRA

Trials by Country

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−

Trials by Country for FASENRA
Location	Trials
United Kingdom	2
Italy	1
Canada	1
Germany	1
United States	1

Trials by US State

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−

Trials by US State for FASENRA
Location	Trials
Maryland	1

Clinical Trial Progress for FASENRA

Clinical Trial Phase

Clinical Trial Phase for FASENRA
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	3
N/A	1

Clinical Trial Status

Clinical Trial Status for FASENRA
Clinical Trial Phase	Trials
Recruiting	3
Active, not recruiting	1
Completed	1

Clinical Trial Sponsors for FASENRA

Sponsor Name

Sponsor Name for FASENRA
Sponsor	Trials
AstraZeneca	2
Dr. Grace Parraga	1
University of Oxford	1

Sponsor Type

Sponsor Type for FASENRA
Sponsor	Trials
Other	4
Industry	2

FASENRA (Benralizumab): Clinical Trials, Market Analysis, and Projections

Introduction

FASENRA (benralizumab) is a humanized IgG1 monoclonal antibody developed by AstraZeneca, designed to target the interleukin-5 (IL-5) receptor on eosinophils. This drug has been approved for several indications, including severe eosinophilic asthma and more recently, eosinophilic granulomatosis with polyangiitis (EGPA). Here, we will delve into the clinical trials, market analysis, and projections for FASENRA.

Clinical Trials Overview

Asthma Trials

FASENRA has undergone several pivotal Phase 3 trials for the treatment of severe eosinophilic asthma.

SIROCCO Trial

The SIROCCO trial, a 48-week study, demonstrated a 51% reduction in the annual asthma exacerbation rate in patients treated with FASENRA plus standard of care compared to those receiving placebo plus standard of care (0.74 vs 1.52, P < 0.0001)[1].

CALIMA Trial

The CALIMA trial, a 56-week study, showed a 28% reduction in the annual asthma exacerbation rate in patients treated with FASENRA plus standard of care compared to those receiving placebo plus standard of care (0.73 vs 1.01, P = 0.019)[1].

ZONDA Trial

The ZONDA trial focused on the reduction of oral corticosteroid (OCS) doses in patients with severe asthma. It showed that FASENRA significantly reduced the final daily OCS dose while maintaining asthma control[1].

COPD Trials

FASENRA is also being investigated for the treatment of chronic obstructive pulmonary disease (COPD).

GALATHEA and TERRANOVA Trials

Although FASENRA did not meet the primary efficacy endpoints in the GALATHEA and TERRANOVA trials for moderate to very severe COPD, these studies provided valuable insights into the potential benefits of FASENRA in patients with elevated blood eosinophil counts and specific clinical characteristics of COPD[3].

EGPA Trial

The MANDARA trial evaluated FASENRA for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune condition. FASENRA demonstrated non-inferiority to GSK’s Nucala, with a 59% remission rate compared to 56% for Nucala. Additionally, more patients in the FASENRA group were able to taper off oral corticosteroids completely[5].

Market Analysis

Current Market Position

FASENRA is approved in over 80 countries, including the US, EU, and Japan, for the treatment of severe eosinophilic asthma and EGPA. It competes with other biologics such as Nucala (mepolizumab) from GlaxoSmithKline and Dupixent (dupilumab) from Sanofi and Regeneron[2][5].

Competitive Landscape

The market for biologics targeting eosinophilic diseases is competitive, with FASENRA facing direct competition from Nucala and indirect competition from Dupixent. However, FASENRA’s unique dosing regimen and its ability to target the IL-5 receptor make it a significant player in this market[2].

Forecasted Sales

Market forecasts indicate that FASENRA’s sales are expected to grow significantly over the next decade. The drug’s market size is projected to increase in major markets such as the US, EU, and Japan, driven by its expanding indications and increasing adoption by healthcare providers[2].

Market Projections

Sales Projections

According to market forecasts, FASENRA’s sales are expected to reach substantial figures by 2032. The report highlights that the market size for FASENRA in the 7MM (seven major markets) is projected to grow significantly, driven by its approval for new indications and increasing market penetration[2].

Geographic Market

The market for FASENRA is expected to grow across various regions, including the US, Germany, France, Italy, Spain, the UK, and Japan. Each of these markets is anticipated to contribute significantly to the overall revenue of FASENRA[2].

Emerging Therapies

The landscape for nasal polyposis and other eosinophilic diseases is evolving, with several late-stage emerging therapies expected to enter the market. However, FASENRA’s established position and ongoing clinical trials for additional indications position it well to maintain its market share[2].

Regulatory Milestones

FDA Approvals

FASENRA has received several FDA approvals, including its initial approval in November 2017 for severe eosinophilic asthma in patients aged 12 years and older. Recent approvals include its use in children aged 6 to 11 with severe eosinophilic asthma and its expansion to treat EGPA[3][5].

Global Regulatory Activities

AstraZeneca is actively filing dossiers in the US, EU, Japan, and China for FASENRA’s use in nasal polyposis and other indications. These regulatory activities are crucial for expanding FASENRA’s global reach and market presence[2].

Safety and Efficacy

Mechanism of Action

FASENRA works by inhibiting the alpha subunit of the IL-5 receptor on eosinophils, thereby reducing eosinophil counts and inflammation. This mechanism is key to its efficacy in treating eosinophilic diseases[3].

Clinical Efficacy

Clinical trials have consistently shown that FASENRA reduces asthma exacerbations, improves lung function, and allows for the tapering of oral corticosteroids. In the MANDARA trial, FASENRA demonstrated comparable efficacy to Nucala in treating EGPA[1][5].

Safety Profile

The safety profile of FASENRA has been consistent across various trials, with no significant new safety concerns identified. The drug has been well-tolerated, making it a viable option for long-term treatment of eosinophilic diseases[5].

Conclusion

FASENRA has established itself as a significant player in the treatment of eosinophilic diseases, including severe asthma and EGPA. With ongoing clinical trials and expanding indications, FASENRA is poised to continue its market growth. Here are the key takeaways:

• Clinical Efficacy: FASENRA has shown significant reductions in asthma exacerbations and improvements in lung function across several clinical trials.
• Market Position: FASENRA competes with other biologics like Nucala and Dupixent but maintains a strong market presence due to its unique dosing regimen and efficacy.
• Regulatory Milestones: Recent FDA approvals and ongoing regulatory activities in various regions are crucial for FASENRA’s global expansion.
• Market Projections: FASENRA’s sales are forecasted to grow substantially by 2032, driven by its expanding indications and increasing market penetration.

Key Takeaways

• Clinical Trials: FASENRA has demonstrated efficacy in reducing asthma exacerbations and improving lung function in several Phase 3 trials.
• Market Competition: FASENRA competes with Nucala and Dupixent but has a unique market position due to its dosing regimen and efficacy.
• Regulatory Approvals: FASENRA has received FDA approvals for severe eosinophilic asthma and EGPA, with ongoing regulatory activities in other regions.
• Market Growth: FASENRA’s sales are projected to grow significantly by 2032, driven by its expanding indications and market penetration.
• Safety Profile: FASENRA has a consistent safety profile, making it a viable long-term treatment option.

FAQs

What is FASENRA used for?

FASENRA (benralizumab) is used for the treatment of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA).

How does FASENRA work?

FASENRA works by inhibiting the alpha subunit of the IL-5 receptor on eosinophils, reducing eosinophil counts and inflammation.

What are the key clinical trials for FASENRA?

Key clinical trials include the SIROCCO, CALIMA, and ZONDA trials for asthma, and the MANDARA trial for EGPA.

Who are the main competitors of FASENRA?

FASENRA competes with Nucala (mepolizumab) from GlaxoSmithKline and Dupixent (dupilumab) from Sanofi and Regeneron.

What are the forecasted sales for FASENRA?

FASENRA’s sales are projected to grow significantly by 2032, with substantial market size increases in the US, EU, and Japan.

Sources

1. FASENRA Pivotal Phase 3 Trials. Fasenrastudies.com.
2. FASENRA (Benralizumab) Emerging Drug Insight and Market Forecast. Researchandmarkets.com.
3. AstraZeneca's Fasenra asthma drug shows promise for COPD treatment. Biopharma-reporter.com.
4. Drug Trials Snapshots: FASENRA. FDA.gov.
5. AstraZeneca Wins Rare Autoimmune Indication for Asthma Biologic Fasenra. Biospace.com.