Graves' Disease - Pipeline Insight, 2024

This “Graves’ Disease- Pipeline Insight, 2024” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Graves’ Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Graves’ Disease: Understanding

Graves’ Disease: Overview

Graves’ Disease (GD) is an autoimmune disease that primarily affects the thyroid gland. It may also affect multiple other organs, including the eyes and skin. It is the most common cause of hyperthyroidism. Graves' disease is caused by thyroid stimulating immunoglobulin (TSI), also known as thyroid stimulating antibody (TSAb). B lymphocytes primarily synthesize Thyroid stimulating immunoglobulin within the thyroid cells, but it can also be synthesized in lymph nodes and bone marrow.

B lymphocytes are stimulated by T lymphocytes which get sensitized by antigen in the thyroid gland. Thyroid stimulating immunoglobulin binds with the thyroid-stimulating hormone (TSH) receptor on the thyroid cell membrane and stimulates the action of the thyroid-stimulating hormone. It stimulates both, thyroid hormone synthesis and thyroid gland growth, causing hyperthyroidism and thyromegaly.

Several environmental factors, including pregnancy (mainly postpartum), iodine excess, infections, emotional stress, smoking, and interferon alfa, trigger immune responses on susceptible genes to eventually cause Graves’ disease.

Graves' orbitopathy (ophthalmopathy) is caused by inflammation, cellular proliferation, and increased growth of extraocular muscles and retro-orbital connective and adipose tissues due to the actions of thyroid stimulating antibodies and cytokines released by cytotoxic T lymphocytes (killer cells). These cytokines and thyroid stimulating antibodies activate periorbital fibroblasts and preadipocytes, causing the synthesis of excess hydrophilic glycosaminoglycans (GAG) and retro-orbital fat growth. Glycosaminoglycans cause muscle swelling by trapping water. These changes give rise to proptosis, diplopia, congestion, and periorbital edema. If left untreated, it eventually leads to irreversible fibrosis of the muscles
The pathogenesis of other rare manifestations of Graves’ disease like pretibial myxedema and thyroid acropachy, is poorly understood and believed to be due to cytokines’ mediated stimulation of fibroblasts. Many symptoms of hyperthyroidism like tachycardia, sweating, tremors, lid lag, and staring are thought to be related to increased sensitivity to catecholamine.

"Graves’ Disease- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Graves’ Disease pipeline landscape is provided which includes the disease overview and Graves’ Disease treatment guidelines. The assessment part of the report embraces, in depth Graves’ Disease commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Graves’ Disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Graves’ Disease R&D. The therapies under development are focused on novel approaches to treat/improve Graves’ Disease.

Graves’ Disease Emerging Drugs Chapters

This segment of the Graves’ Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Graves’ Disease Emerging Drugs

Batoclimab: Immunovant Sciences GmbH

Batoclimab (IMVT-1401) is a novel, fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). The FcRn receptor facilitates IgG recycling. Batoclimab enhances the degradation of IgG by targeting FcRn and preventing endogenous IgG from binding. This increased catabolism of IgG may curtail the harmful immune response exhibited by auto-antibodies.

In nonclinical studies and in clinical trials conducted, batoclimab was observed to reduce IgG antibody levels. High levels of pathogenic IgG antibodies drive a variety of autoimmune diseases and, as a result, the company believes that this product candidate has the potential to address a variety of IgG-mediated autoimmune diseases as a self-administered subcutaneous injection. The drug is currently being investigated in the Phase III stage of development for the treatment of Graves’ Disease.

VRDN-001: Viridian Therapeutics

VRDN-001, is a differentiated monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), a clinically and commercially validated target for the treatment of thyroid eye disease (TED). In preclinical studies, VRDN-001 was shown to be a full antagonist of IGF-1R, with more complete receptor blockade than other anti-IGF-1R antibodies, including the approved TED therapy.

Data from the initial dose cohorts of the Phase 2 portion of the ongoing trial established clinical proof-of-concept for VRDN-001 in patients with active TED. Preliminary data from the ongoing trial showed treatment with VRDN-001 led to reductions in proptosis, clinical activity score (CAS), and diplopia resolution. VRDN-001 was generally safe and well tolerated in the trial.

The company initiated the THRIVE Phase III trial in patients with active TED to support global marketing registration. VRDN-001 is also being evaluated in Phase II trial cohorts in patients with chronic TED. Pending positive results, the company plans to start its THRIVE-2 Phase III trial in patients with chronic TED.

Linsitinib: Sling Therapeutics

Linsitinib is an oral small molecule that works by inhibiting the validated IGF-1R target. Linsitinib has established a safety profile through the treatment of over 800 patients. It is also being investigated for the treatment of additional autoimmune and rare diseases. Currently, linsitinib is in a Phase II/III trial for Graves’ Disease.

Graves’ Disease: Therapeutic Assessment

This segment of the report provides insights about the different Graves’ Disease drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Graves’ Disease

There are approx. 8+ key companies which are developing the therapies for Graves’ Disease. The companies which have their Graves’ Disease drug candidates in the most advanced stage, i.e. phase III include, Immunovant Sciences GmbH.

Phases

The report covers around 10+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Graves’ Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Graves’ Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Graves’ Disease therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Graves’ Disease drugs.

Graves’ Disease Report Insights

• Graves’ Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Graves’ Disease Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Graves’ Disease drugs?
• How many Graves’ Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Graves’ Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Graves’ Disease therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Graves’ Disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Viridian Therapeutics
• Immunovant Sciences GmbH
• Apitope International NV
• Sling Therapeutics
• Novartis Pharmaceuticals

Key Products

• VRDN-001
• Batoclimab
• Linsitinib
• CFZ533
• K1-70

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