CLINICAL TRIALS PROFILE FOR RESLIZUMAB

All Clinical Trials for reslizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00635089 ↗	Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis	Completed	Cephalon	Phase 3	2008-07-01	This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434). The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.
NCT00635089 ↗	Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis	Completed	Ception Therapeutics	Phase 3	2008-07-01	This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434). The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.
NCT01111305 ↗	Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2010-04-01	Diethylcarbamazine citrate (DEC) treatment of Loa loa infection is complicated by the development of severe adverse reactions that are correlated with the number of circulating microfilariae in the blood. The cause of these reactions is unknown, but they are accompanied by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of eosinophil activation. This randomized, placebo-controlled, double-blind pilot study (conducted at the NIH Clinical Center) will assess whether and to what extent the administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against IL-5, given 3 to 7 days before administration of the anthelminthic drug DEC (at 3 mg/kg 3 times daily for 21 days), prevents the development of eosinophilia in 10 adult subjects with Loa loa infection and 0-5000 microfilariae/mL. Secondary outcomes will include the severity of post-treatment effects, markers of eosinophil activation, and effects of reslizumab on microfilarial clearance.
NCT01270464 ↗	A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3	2011-02-01	The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).
NCT01270464 ↗	A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma	Completed	Teva Branded Pharmaceutical Products, R&D Inc.	Phase 3	2011-02-01	The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).
NCT01285323 ↗	A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3	2011-03-01	The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.
NCT01285323 ↗	A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma	Completed	Teva Branded Pharmaceutical Products, R&D Inc.	Phase 3	2011-03-01	The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

Clinical Trial Conditions for reslizumab

Condition Name

Condition Name for reslizumab
Intervention	Trials
Asthma	6
Eosinophilic Asthma	5
Eosinophils, Asthma	1
Loiasis	1

Condition MeSH

Condition MeSH for reslizumab
Intervention	Trials
Asthma	13
Pulmonary Eosinophilia	8
Churg-Strauss Syndrome	1
Eosinophilia	1

Clinical Trial Locations for reslizumab

Trials by Country

Trials by Country for reslizumab
Location	Trials
United States	197
Canada	14
Germany	11
Spain	8
France	7

Trials by US State

Trials by US State for reslizumab
Location	Trials
California	12
Florida	9
Texas	9
Ohio	9
Colorado	8

Clinical Trial Progress for reslizumab

Clinical Trial Phase

Clinical Trial Phase for reslizumab
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	12
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for reslizumab
Clinical Trial Phase	Trials
Completed	12
Terminated	4
Unknown status	2

Clinical Trial Sponsors for reslizumab

Sponsor Name

Sponsor Name for reslizumab
Sponsor	Trials
Teva Branded Pharmaceutical Products R&D, Inc.	10
Teva Branded Pharmaceutical Products, R&D Inc.	9
Teva Pharmaceuticals USA	3

Sponsor Type

Sponsor Type for reslizumab
Sponsor	Trials
Industry	29
Other	6
NIH	1

Reslizumab Market Analysis and Financial Projection

Reslizumab: Clinical Trials, Market Analysis, and Projections

Introduction to Reslizumab

Reslizumab, marketed under the brand name Cinqair, is a humanized anti-interleukin 5 (IL-5) monoclonal antibody. It is designed to disrupt eosinophil maturation and promote programmed cell death, making it a significant treatment option for patients with severe asthma characterized by elevated blood eosinophil counts[1][4].

Clinical Trials and Efficacy

Study Design and Patient Population

The efficacy and safety of reslizumab were assessed in two duplicate, multicentre, double-blind, parallel-group, randomised, placebo-controlled phase 3 trials. These trials enrolled patients aged 12-75 years with inadequately controlled, moderate-to-severe asthma, despite treatment with medium-to-high doses of inhaled corticosteroids. Patients had blood eosinophils of 400 cells per μL or higher and had experienced one or more exacerbations in the previous year[1].

Key Findings

In both studies, patients receiving reslizumab showed a significant reduction in the frequency of asthma exacerbations compared to those receiving placebo. The rate ratio for exacerbations was 0.50 (95% CI 0.37-0.67) in study 1 and 0.41 (95% CI 0.28-0.59) in study 2, both with p-values less than 0.0001. Additionally, reslizumab improved lung function, with a mean increase in forced expiratory volume in one second (FEV1) of 160 ml compared to placebo over 16 weeks[1][4].

Safety Profile

Common adverse events in the reslizumab group were similar to those in the placebo group, including worsening asthma symptoms, upper respiratory tract infections, and nasopharyngitis. Two patients in the reslizumab group experienced anaphylactic reactions, which were resolved with standard treatment[1].

Market Analysis

Current Market Position

Reslizumab is part of a growing market for biologic treatments targeting severe asthma. It competes with other anti-IL-5 therapies such as mepolizumab (Nucala) and benralizumab. Indirect treatment comparisons have shown that while reslizumab is effective, mepolizumab may offer greater reductions in clinically significant exacerbations and improved asthma control across various eosinophil levels[3].

Market Projections

The global asthma market, particularly the segment targeting severe eosinophilic asthma, is expected to grow as the prevalence of asthma increases and more patients are diagnosed with eosinophilic phenotypes. However, the market share of reslizumab may be influenced by the presence of other effective treatments and the overall healthcare landscape.

Competitive Landscape

Comparison with Other Anti-IL-5 Therapies

Reslizumab faces competition from mepolizumab and benralizumab. Mepolizumab has been shown to reduce clinically significant exacerbations by 34%–45% compared to benralizumab and by 45% compared to reslizumab in patients with similar blood eosinophil counts[3].

Impact of Market Dynamics

The asthma biologics market is dynamic, with ongoing research and development of new treatments. The market is also subject to factors such as patent expirations, biosimilar competition, and changes in healthcare policies, all of which can impact the market share and growth potential of reslizumab.

Dosing and Administration

Reslizumab is administered intravenously at a dose of 3 mg/kg every 4 weeks. This dosing regimen is based on the patient's body weight and is intended to reduce exacerbations, relieve symptoms, and improve lung function in patients with severe asthma and elevated blood eosinophils[4].

Regulatory Status

Reslizumab was approved by the FDA in 2016 for the treatment of adults and adolescents (12 years of age and older) with severe asthma and an eosinophilic phenotype who are inadequately controlled on inhaled corticosteroids. However, the FDA did not support approval for pediatric patients aged 12 to 17 years due to concerns about efficacy and safety in this age group[4].

Benefit-Risk Assessment

Clinical trials have demonstrated that reslizumab provides statistically significant and clinically meaningful improvements in lung function and reductions in asthma exacerbations. However, there are limitations in the safety database, particularly regarding the potential for infections or myopathy when used in conjunction with oral corticosteroids. A physician treating 1,000 patients with reslizumab for one year could expect to prevent 182 asthma exacerbations and 5 asthma hospitalizations[4].

Market Growth Drivers and Barriers

Growth Drivers

• Increasing prevalence of asthma and diagnosis of eosinophilic phenotypes.
• Growing demand for biologic treatments due to their efficacy in reducing exacerbations and improving lung function.
• Expansion into new markets and patient populations.

Barriers

• Competition from other anti-IL-5 therapies and emerging treatments.
• Patent expirations and the introduction of biosimilars, which could reduce market share.
• Regulatory and healthcare policy changes that may affect reimbursement and access to the drug.

Future Outlook

The future outlook for reslizumab is tied to its ability to compete effectively in the market and address unmet needs in severe asthma treatment. As the asthma biologics market continues to evolve, reslizumab will need to demonstrate sustained efficacy and safety to maintain its market position.

Key Takeaways

• Reslizumab significantly reduces asthma exacerbations and improves lung function in patients with severe asthma and elevated blood eosinophils.
• It competes with other anti-IL-5 therapies like mepolizumab and benralizumab.
• The drug is administered intravenously every 4 weeks at a dose of 3 mg/kg.
• Regulatory approval is limited to adults and adolescents aged 12 and older.
• Market growth is driven by increasing demand for biologic treatments but faces competition and regulatory challenges.

Frequently Asked Questions (FAQs)

1. What is reslizumab used for?

Reslizumab is used to reduce exacerbations, relieve symptoms, and improve lung function in adults and adolescents (12 years of age and older) with severe asthma and elevated blood eosinophils who are inadequately controlled on inhaled corticosteroids.

2. How is reslizumab administered?

Reslizumab is administered intravenously at a dose of 3 mg/kg every 4 weeks.

3. What are the common adverse events associated with reslizumab?

Common adverse events include worsening asthma symptoms, upper respiratory tract infections, and nasopharyngitis.

4. How does reslizumab compare to other anti-IL-5 therapies?

Reslizumab has been shown to be effective, but indirect treatment comparisons suggest that mepolizumab may offer greater reductions in clinically significant exacerbations and improved asthma control.

5. What are the regulatory limitations for reslizumab?

The FDA did not support approval for pediatric patients aged 12 to 17 years due to concerns about efficacy and safety in this age group.

Cited Sources:

1. Castro, M., et al. "Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials." The Lancet Respiratory Medicine, vol. 3, no. 5, 2015, pp. 355-366.
2. GlobalData. "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025." Drug Development & Delivery, 2022.
3. GlaxoSmithKline plc. "GSK announces results of indirect treatment comparisons of Nucala to benralizumab and reslizumab for severe eosinophilic asthma." GSK Press Release, 10 Sep 2018.
4. FDA. "761033 Reslizumab Clinical PREA." FDA Clinical Review, 2016.