Axial spondyloarthritis (axSpA) - Pipeline Insight, 2023

DelveInsight's , "Axial spondyloarthritis (axSpA) - Pipeline Insight, 2023" report provides comprehensive insights about 15+companies and 15+pipeline drugs in Axial spondyloarthritis (axSpA) 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

Axial spondyloarthritis (axSpA): Understanding

Axial spondyloarthritis (axSpA): Overview

Axial spondyloarthritis (axSpA) is a type of arthritis that mostly affects the spine. It mostly causes pain and swelling in the spine and the joints that connect the bottom of the spine to the pelvis (sacroiliac joint). Other joints can be affected as well. It is a systemic disease, which means it may affect other body parts and organs. The disease tends to run in families.

There are two types of axSpA:

• Radiographic axSpA (also called ankylosing spondylitis or AS) includes damage to the sacroiliac joints and spine that can be seen on X-rays.
• Nonradiographic axSpA (nr-axSpA) does not include damage you can see on X-rays but it may show up on magnetic resonance images (MRIs).

The disease can occur at any age, but typically begins between ages 20 and 40. AS is more common in men than in women. However, nr-axSpA may be just as common in women as in men. It is less common among African Americans than people of other racial backgrounds. The exact cause of axSpA is not clear. Researchers believe that people with certain genes develop axSpA when they are exposed to a virus, bacteria or another trigger. Many people with axSpA have a gene called HLA-B27. But most people that have the gene never develop axSpA.

Symptoms

Low back, buttocks and hip pain are usually the first symptoms. Children, however, may have pain in the hips, knees or heels before the back. Symptoms of axSpA include:

• Pain in the low back, buttocks and hips that develops slowly over weeks or months.
• Pain, swelling, redness and warmth in the toes, heels, ankles, knees, rib cage, upper spine, shoulders and neck.
• Stiffness when first waking up or after long periods of rest.
• Back pain during the night or early morning.
• Fatigue.
• Appetite loss

Diagnosis

There is no single test to diagnose axSpA. A physical exam and few tests are performed to rule out other causes of back and hip pain.

• Physical examination: Signs of tenderness, swelling and pain in the spine, pelvis and hips, how the joints move and sometimes the eyes.
• Blood tests: A test for the HLA-B27 gene, having this gene doesn't mean the presence of axSpA, but it can help with diagnosis. Other tests will check for body-wide inflammation.
• Imaging tests: X-rays, ultrasound, MRI or CT scans of the pelvis and spine to look for damage.

Treatment

There is no cure for axSpA, but treatment aims to relieve pain and stiffness in the back and affected areas, keep the spine straight, prevent joint and organ damage, preserve joint function and mobility and improve quality of life.

Medications

• Nonsteroidal anti-inflammatory drugs: NSAIDs are the most commonly used drugs to treat axSpA and help relieve pain. They include over-the-counter drugs, such as ibuprofen (Advil) and naproxen (Aleve), as well as the prescription drugs indomethacin, diclofenac or celecoxib.
• Analgesics: In addition to NSAIDs, the doctor may recommend acetaminophen (Tylenol) for pain relief.
• Disease-modifying antirheumatic drugs (DMARDs): Conventional DMARDs are not usually used in people with axSpA that effects just the back. Sulfasalazine, however, may be used for joints other than those in the back and pelvis.
• Biologics: A type of DMARD, biologics target certain proteins and processes in the body to control disease. Biologics are self-injected or given by infusion at a doctor's office. The ones that work best for axSpA are tumor necrosis factor (TNF) inhibitors and interleukin (IL-17) inhibitors.
• Corticosteroids: These powerful drugs are not often used for spinal disease in axSpA. However, injecting steroids into a knee or shoulder can provide quick relief.

Exercise

Regular physical activity is a critical part of managing axSpA and Physical Therapy and Assistive Devices can protect joints and making daily tasks easier.

Surgery

Most people with axSpA will never need surgery. But joint replacement can help people with severe pain or joint damage. Surgery may also help straighten a severely bent forward spine.

"Axial spondyloarthritis (axSpA)- Pipeline Insight, 2023" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Axial spondyloarthritis (axSpA) pipeline landscape is provided which includes the disease overview and Axial spondyloarthritis (axSpA) treatment guidelines. The assessment part of the report embraces, in depth Axial spondyloarthritis (axSpA) 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, Axial spondyloarthritis (axSpA) 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 Axial spondyloarthritis (axSpA) R&D. The therapies under development are focused on novel approaches to treat/improve Axial spondyloarthritis (axSpA).

Axial spondyloarthritis (axSpA) Emerging Drugs Chapters

This segment of the Axial spondyloarthritis (axSpA) 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.

Axial spondyloarthritis (axSpA) Emerging Drugs

Filgotinib: Galapagos NV

Filgotinib is marketed as Jyseleca in Europe and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib is also marketed as Jyseleca in Europe and Japan for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

Filgotinib is a JAK1 preferential inhibitor orally administered once daily, and is currently in Phase III trial in axial spondyloarthritis (AxSpA).

SHR0302: Jiangsu Hengrui Pharmaceutical Co., Ltd.

SHR0302 is a highly selective JAK1 inhibitor, which can exert anti-inflammatory and immune-suppressing biological effects by inhibiting JAK1 signal transduction, and is clinically planned for the treatment of active radiologically negative axial spondyloarthritis. SHR0302 tablets are expected to become a new treatment option for active nr-axSpA, benefiting the majority of nr-axSpA patients.

SHR0302 has been approved to carry out a number of clinical studies. In addition to nr-axSpA, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, Crohn's disease, atopic dermatitis, arthritis, ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, etc. are in the clinical Phase III.

AK111: Akeso, Inc.

AK111 is a novel drug targeting IL-17A of autoimmune treatment diseases independently developed by the Company. AK111 is intended to be used for the treatment of psoriasis, ankylosing spondylitis and axial spondylitis. Through combination of competitive blockers, namely IL-17A and IL-17RA, and blocking the biological activities of IL-17, AK111 has reached the efficacy in immune-related diseases in clinical therapies. Currently, AK111 for treatment of ankylosing spondylitis is investigated in phase II clinical trial.

Further product details are provided in the report……..

Axial spondyloarthritis (axSpA): Therapeutic Assessment

This segment of the report provides insights about the different Axial spondyloarthritis (axSpA) drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Axial spondyloarthritis (axSpA)

There are approx. 15+key companies which are developing the therapies for Axial spondyloarthritis (axSpA). The companies which have their Axial spondyloarthritis (axSpA) drug candidates in the most advanced stage, i.e. phase III include, Galapagos NV.

Phases

DelveInsight's report covers around 15+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

Axial spondyloarthritis (axSpA) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• Product Type

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

Axial spondyloarthritis (axSpA): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Axial spondyloarthritis (axSpA) 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 Axial spondyloarthritis (axSpA) drugs.

Axial spondyloarthritis (axSpA) Report Insights

• Axial spondyloarthritis (axSpA) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Galapagos NV
• Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Akeso, Inc.
• Izana Bioscience Ltd.
• Biocad
• Mabpharm Limitied
• Shilpa Biologicals

Key Products

• Filgotinib
• SHR0302
• AK111
• Namilumab
• BCD-180
• CMAB015
• SBDM-002