Behcet's Disease - Pipeline Insight, 2024

This “Behcet’s Disease - Pipeline Insight, 2024” report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in Behcet’s 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

Behcet’s Disease: Understanding

Behcet’s Disease: Overview

Behcet disease, described in 1937 by Hulusi Behçet, is an auto-inflammatory systemic vasculitis of unknown cause. It presents with recurrent oral and genital ulcers, ocular inflammation like chronic uveitis, and systemic vasculitis affecting both arteries and veins. Known also as Behcet syndrome, its etiology involves genetic and environmental factors. The disease is notably associated with the HLA-B51/B5 gene, prevalent in Japanese, Middle Eastern, and Turkish populations. Other genes like those for TNF and heat shock proteins have been implicated. Infectious agents, especially Streptococcus sanguinis, are considered potential triggers. Unlike other vasculitides, Behcet disease lacks necrotizing vasculitis or giant cell formation, and features venular involvement and arterial aneurysms. No specific autoantibodies are present. The disease involves significant Th1 cell-mediated immunity, with increased pro-inflammatory cytokines (IL-1, IL-8, IL-12, IL-17, IL-37, and TNF) and heightened macrophage and neutrophil activity, leading to tissue injury. Circulating immune complexes and endothelial dysfunction further contribute to its pathogenesis.

Diagnosing Behcet disease is clinical and challenging due to the absence of pathognomonic laboratory findings, with non-specific results like anemia of chronic disease, leukocytosis, and elevated inflammation markers. Diagnostic imaging should target the affected organ, including X-rays and arthrocentesis for arthritis, CT scans for bleeding, thrombosis, and ischemia, angiography for aneurysms, and lumbar puncture for meningitis, primarily to exclude other conditions. Initial presentations require careful ophthalmologic examinations for ocular involvement and biopsies of cutaneous lesions for confirmation. The International Team for the Revision of International Criteria for Behçet Disease (ITR-ICBD) in 2008 proposed point-based criteria: 1 point each for oral aphthosis, skin manifestations, vascular lesions, and a positive pathergy test, and 2 points each for genital aphthosis and ocular lesions, with 3 or more points needed for diagnosis. However, conditions like inflammatory bowel disease, systemic lupus erythematosus, reactive arthritis, and herpetic infections can mimic Behcet disease and must be ruled out first.

Treatment aims to suppress inflammation, prevent relapses, and manage symptoms, often using a combination of topical and systemic therapies tailored to the patient's symptoms and disease severity. Topical treatments, like corticosteroid pastes, ointments, or gels, manage oral and genital ulcers, while systemic therapies include corticosteroids, immunosuppressants (e.g., azathioprine, cyclosporine), and biologic agents (e.g., infliximab). Corticosteroids control acute inflammation quickly, and immunosuppressants and biologics are used for long-term management and relapse prevention. Severe or refractory cases may require experimental therapies like thalidomide, dapsone, or interferon-alpha. A multidisciplinary approach and regular monitoring for complications are essential for optimal outcomes.

"Behcet’s Disease- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Behcet’s Disease pipeline landscape is provided which includes the disease overview and Behcet’s Disease treatment guidelines. The assessment part of the report embraces, in depth Behcet’s 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, Behcet’s 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 Behcet’s Disease R&D. The therapies under development are focused on novel approaches to treat/improve Behcet’s Disease.

Behcet’s Disease Emerging Drugs Chapters

This segment of the Behcet’s Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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.

Behcet’s Disease Emerging Drugs

Dusquetide: Soligenix

Dusquetide (the active ingredient in SGX945 (Behçet's disease) and SGX942 (oral mucositis) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective, and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. Dusquetide also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma, and chemo- and/or radiation therapy. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Behçet's disease.

Behcet’s Disease: Therapeutic Assessment

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

Major Players in Behcet’s Disease

• There are approx. 4+ key companies which are developing the therapies for Behcet’s Disease. The companies which have their Behcet’s Disease drug candidates in the most advanced stage, i.e. Phase II include, Soligenix.

Phases

This report covers around 4+ 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

Behcet’s 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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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

Behcet’s Disease: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Behcet’s 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 Behcet’s Disease drugs.

Behcet’s Disease Report Insights

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

Behcet’s 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 Behcet’s Disease drugs?
• How many Behcet’s Disease drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Behcet’s Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Behcet’s 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 Behcet’s Disease and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Soligenix
• Poolbeg Pharma
• Chugai Pharmaceutical

Key Products

• Dusquetide
• Pentoxifylline
• RAY121

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