Gouty Arthritis (Gout) - Pipeline Insight, 2024

This “Gout - Pipeline Insight, 2024,” report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Gout 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

Gout Understanding

Gout: Overview

Gout is a chronic disease caused by monosodium urate (MSU) crystal deposition in joints. It typically presents as an acute, self-limiting inflammatory monoarthritis that affects the joints of the lower limb. Gout is the most common form of inflammatory arthritis, which affected approximately 9.2 million adults (3.9%) in the US in 2016. Gout may result from chronic hyperuricemia, defined as a serum urate level >7.0 mg/dL in men and >6.0 mg/dL in women. Common symptoms include swelling, stiffness, tenderness, warmth, and redness in and around joints. Men can be three times more likely than women to get it as they have higher uric acid levels most of their lives. It generally occurs after menopause in women. Triggers for acute attacks (flare-ups) of gout include surgery, dehydration, beverages sweetened with sugar or high fructose corn syrup, beer, liquor, red meat, and seafood. If left untreated, gout can cause irreversible joint damage, kidney problems, and tophi. The main goals of gout treatment are to prevent uric acid buildup and reduce inflammation that can affect joints and organs. The drugs of the first choice for acute gouty arthritis are nonsteroidal anti-inflammatory drugs (NSAID), corticosteroids, and colchicine.

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

Gout Emerging Drugs Chapters

This segment of the Gout 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.

Gout Emerging Drugs

SEL-212: Selecta Biosciences

SEL-212 is a novel combination product candidate designed to sustain control of serum uric acid (SUA) levels1 in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. SEL-212 is comprised of Imm TOR co-administered with pegadricase, a highly immunogenic enzyme that, when given alone, decreases serum uric acid levels in patients with chronic refractory gout but triggers an immune response to the treatment, as measured by the production of anti-drug antibodies (ADAs). ADAs develop due to unwanted immune responses to biologic medicines, may reduce their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout. Selecta licensed its Phase III clinical product candidate, SEL-212, in chronic refractory gout, to Sobi in mid-2020. SEL-212 is currently being evaluated in a Phase 3 clinical trial being run by Selecta on behalf ofSobi.

SHR4640: Jiangsu Hengrui Medicine

SHR4640, a URAT1 inhibitor drug candidate is being developed and investigated in Phase III stage of development for the treatment of hyperuricemia and gout. Human urate transporter 1 (URAT1), which is an influx transporter protein, is located at the apical surface of renal tubular cells and presumed to be the major transporter responsible for the reabsorption of urate from blood. About 90% of patients develop hyperuricemia due to insuf?cient urate excretion; thus, it is important to develop URAT1 inhibitors that could enhance renal urate excretion by blocking the reabsorption of urate anion.

LC350189: LG Chem

LC350189 is a novel xanthine oxidase inhibitor targeting the reduction of uric acid in the final product in purine metabolism, by inhibiting the activity of xanthine oxidase. It has a different structure from other xanthine oxidase inhibitors such as the purine analog xanthine oxidase inhibitor, allopurinol. LC350189 is being developed for the treatment of gout by LG Chem.

SAP-001: Shanton Pharma

SAP-001 is viewed as a novel clinical stage agent with disease modification potential for gout patientswith highly safe, efficacious, well-tolerated and easily administered. SAP-001 is being developed for the treatment of gout by Shanton Pharma. It is currently in Phase II stage of development.

D-0120: InventisBio

D-0120 is a novel oral selective uric acid transporter (URAT1) inhibitor being developed for the treatment of hyperuricemia and gout by blocking the reabsorption of uric acid (UA) within the renal proximal tubule, thereby reducing serum uric acid concentrations. As a novel URAT1 inhibitor, D-0120 is anticipated to have more potent serum UA reducing effect than the approved URAT1 inhibitor lesinurad, but with less toxicity and wider therapeutic window. The pharmacological potential of D-0120 for the treatment of hyperuricemia and gout was demonstrated in preclinical studies. The results of the in vitro h URAT1 expressed CHO cell model showed that the inhibitory activity of D-0120 is 150-fold more potent than lesinurad and slightly more potent than verinurad. A Phase I clinical trial for D-0120 has been completed in the US, and good efficacy and excellent safety profile have been observed. A Phase I/II clinical trial for D-0120 is currentlyongoing.

Gout: Therapeutic Assessment

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

Major Players in Gout

There are approx. 40+ key companies which are developing the therapies for Gout. The companies which have their Gout drug candidates in the most advanced stage, i.e. phase III include, Selecta Biosciences.

Phases

This report covers around 40+ 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

Gout 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
• Oral
• Parenteral
• Subcutaneous
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Protein
• Small interfering RNA
• Small molecule

Product Type

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

Gout: Pipeline Development Activities

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

Gout Report Insights

• Gout Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

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