CLINICAL TRIALS PROFILE FOR OMALIZUMAB

Biosimilar Clinical Trials for omalizumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05053334 ↗	Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair	Not yet recruiting	CuraTeQ Biologics Private Ltd.	Phase 1	2021-11-01	A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.
NCT05053334 ↗	Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair	Not yet recruiting	Syneos Health	Phase 1	2021-11-01	A single dose, double blind comparative trial to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male volunteers.

All Clinical Trials for omalizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00046748 ↗	Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma	Completed	Novartis Pharmaceuticals	Phase 3	2001-12-01	The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.
NCT00079937 ↗	Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma	Completed	Novartis Pharmaceuticals	Phase 3	2004-04-01	A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.
NCT00084097 ↗	Omalizumab to Treat Eosinophilic Gastroenteritis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2004-06-02	This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in reducing eosinophil counts and improving symptoms in patients with eosinophilic gastroenteritis (EG). EG is a disorder of unknown cause in which eosinophils, a type of white blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or environmental allergies, which may play a role in EG. Some patients with EG improve significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is an antibody that plays an important role in initiating allergic reactions. Omalizumab is a monoclonal antibody directed against IgE. The Food and Drug Administration approved omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma. Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests. Participants undergo the following procedures: - Leukapheresis. This procedure is done to collect quantities of white blood cells to study the effects of omalizumab on eosinophils and other immune substances. Blood flows from a needle placed in an arm vein through a catheter (plastic tube) into a machine that separates the blood into its components by centrifugation (spinning). Some of the white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm. - Skin testing. Participants are tested for allergies to specific substances. A small amount of various allergens (substances that cause allergies) are placed on the subject's arm. The skin is pricked at the sites of the allergens and the skin reaction after several minutes is observed. - Upper and lower endoscopy. One or both of these procedures is done, depending on the part of the gastrointestinal tract that is involved, to examine the tract. If both procedures are done, they are performed at the same time. For the upper endoscopy, the subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is passed through the rectum into t...

Clinical Trial Conditions for omalizumab

Condition Name

Condition Name for omalizumab
Intervention	Trials
Asthma	47
Chronic Spontaneous Urticaria	12
Allergic Asthma	11

Condition MeSH

Condition MeSH for omalizumab
Intervention	Trials
Asthma	63
Urticaria	31
Chronic Urticaria	25

Clinical Trial Locations for omalizumab

Trials by Country

Trials by Country for omalizumab
Location	Trials
United States	474
Canada	45
Germany	40
China	35
Spain	31

Trials by US State

Trials by US State for omalizumab
Location	Trials
California	33
Maryland	30
New York	24
Ohio	20
Texas	19

Clinical Trial Progress for omalizumab

Clinical Trial Phase

Clinical Trial Phase for omalizumab
Clinical Trial Phase	Trials
Phase 4	51
Phase 3	35
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for omalizumab
Clinical Trial Phase	Trials
Completed	105
Recruiting	18
Not yet recruiting	13

Clinical Trial Sponsors for omalizumab

Sponsor Name

Sponsor Name for omalizumab
Sponsor	Trials
Genentech, Inc.	39
Novartis Pharmaceuticals	33
Novartis	21

Sponsor Type

Sponsor Type for omalizumab
Sponsor	Trials
Other	146
Industry	129
NIH	18

Omalizumab: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Omalizumab, marketed as Xolair, is a monoclonal antibody that has been a significant player in the treatment of various allergic conditions. Recently, it has garnered attention for its approval in a new indication: the reduction of allergic reactions to food. Here, we delve into the latest clinical trials, market analysis, and projections for omalizumab.

Clinical Trials and FDA Approval

In February 2024, the FDA approved omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adults and children aged 1 year and older with food allergy. This approval was based on data from the Phase 3 clinical trial known as OUtMATCH (Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID)[1][4].

The OUtMATCH trial demonstrated a significant effect size in multi-allergen desensitization compared to placebo, although some participants did not respond, and the percentage of responders tolerating all three food allergens was lower than that for single foods. The trial's results highlight the potential of omalizumab in managing food allergies but also underscore the need for further research on patient selection, treatment responsiveness, and off-label considerations[1][4].

Market Analysis

Global Market

Omalizumab has been approved for several indications globally, including moderate-to-severe persistent allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis. The recent approval for food allergy adds to its growing market potential.

Chinese Market

In China, omalizumab has seen significant growth, particularly during the COVID-19 pandemic. The sales value of omalizumab in China reached CNY41.61 million in 2020, with an annual growth rate of 281.5% and a compound annual growth rate (CAGR) of 163.2% from 2018 to 2020. This growth is attributed to its inclusion in China's medical insurance for respiratory diseases and its effectiveness compared to other treatments for moderate to severe asthma[2][5].

China, with approximately 30 million asthma patients in 2020, presents a substantial market for omalizumab. The drug's market share is expected to increase due to its therapeutic advantages over inhaled corticosteroids and long-acting inhaled β2-adrenergic receptor agonists[2][5].

Market Projections

Future Growth

The sales of omalizumab in China are predicted to continue growing from 2021 to 2025, driven by the increase in the number of approved indications. Globally, omalizumab has four approved indications, while in China, it has only one, leaving room for expansion[2][5].

In the US, the market potential for omalizumab in food allergy is substantial, with estimates suggesting peak sales of around $4.5 billion. Additionally, its use in chronic spontaneous urticaria (CSU) could add another $1 billion in peak revenues[3].

Competitive Landscape

The market for anti-IgE monoclonal antibodies is evolving, with new candidates emerging. RAPT Therapeutics is developing RPT904, a half-life extended (HLE) version of omalizumab, which promises less frequent dosing and increased patient compliance. This could potentially challenge omalizumab's market share, especially if RPT904 achieves its projected best-in-class profile[3].

Commercial Opportunity

Food Allergy

The approval of omalizumab for food allergy has opened up a significant commercial opportunity. According to Roche, there are approximately 17 million patients in the US with food allergies, with about 50% experiencing severe reactions. Omalizumab's rapid launch saw 30,000 patients on treatment within the first two quarters, highlighting the high unmet need for effective multi-allergen treatments[3].

Chronic Spontaneous Urticaria (CSU)

In CSU, omalizumab is the only approved biologic after antihistamine failure, affecting over 1 million patients in the US. RPT904 is positioned to be a preferred choice due to its improved convenience and compliance, potentially capturing a significant share of this market[3].

Challenges and Future Directions

Clinical Practice Implementation

The implementation of omalizumab in clinical practice for food allergy raises several questions, including appropriate patient selection, monitoring for treatment responsiveness, and managing off-label considerations. Additional research is necessary to ensure high-quality outcomes in real-world practice[4].

Regulatory and Market Dynamics

The market for omalizumab will be influenced by regulatory approvals, insurance coverage, and the emergence of new treatments. Continuous monitoring of these factors will be crucial for predicting future market trends.

Key Takeaways

• FDA Approval: Omalizumab has been approved for reducing allergic reactions to food, based on the OUtMATCH trial.
• Market Growth: Significant growth in China, driven by inclusion in medical insurance and COVID-19 pandemic.
• Global Potential: Estimated peak sales of $4.5 billion in the US for food allergy and $1 billion for CSU.
• Competitive Landscape: Emerging competitors like RPT904 could challenge omalizumab's market share.
• Clinical Practice: Need for further research on patient selection and treatment responsiveness.

FAQs

What is omalizumab, and what is it used for?

Omalizumab is a monoclonal antibody used to treat various allergic conditions, including moderate-to-severe persistent allergic asthma, chronic spontaneous urticaria, chronic rhinosinusitis, and recently approved for reducing allergic reactions to food.

What is the OUtMATCH trial, and what were its findings?

The OUtMATCH trial is a Phase 3 clinical trial that evaluated omalizumab as a monotherapy and as an adjunct therapy for multi-allergen oral immunotherapy in food-allergic children and adults. The trial demonstrated a significant effect size in multi-allergen desensitization compared to placebo.

How has the COVID-19 pandemic affected omalizumab sales in China?

The COVID-19 pandemic led to an increase in omalizumab sales in China, with the sales value reaching CNY41.61 million in 2020 and a CAGR of 163.2% from 2018 to 2020.

What are the market projections for omalizumab in the US?

In the US, omalizumab is projected to achieve peak sales of around $4.5 billion for food allergy and $1 billion for chronic spontaneous urticaria.

Are there any emerging competitors to omalizumab?

Yes, RAPT Therapeutics is developing RPT904, a half-life extended version of omalizumab, which promises less frequent dosing and increased patient compliance, potentially challenging omalizumab's market share.

Sources

1. NIH Trial Data Underpins FDA Approval of Omalizumab for Food Allergy. National Institute of Allergy and Infectious Diseases. February 16, 2024.
2. Investigation Report on China's Omalizumab Market 2021-2025. ResearchAndMarkets.com.
3. Corporate Presentation - Investor Relations | RAPT Therapeutics, Inc.. RAPT Therapeutics. December 23, 2024.
4. Omalizumab Implementation in Practice: Lessons Learned From the OUtMATCH Trial. PubMed. February 2024.
5. Investigation Report on China's Omalizumab Markets, 2016-2020. BusinessWire. March 7, 2022.