Scleroderma- Pipeline Insight, 2023

Scleroderma- Pipeline Insight, 2023

DelveInsight’s, “Scleroderma- Pipeline Insight, 2023” report provides comprehensive insights about 45+ companies and 50+ pipeline drugs in Scleroderma 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

Scleroderma: Understanding

Scleroderma: Overview

Scleroderma is a connective tissue disorder characterized primarily by the thickening and hardening of the skin. The combining form “sclero” means ""hard"" in Greek, and the word “dermis” means skin. There are two primary types of scleroderma: localized and systemic (also called systemic sclerosis). In localized scleroderma, the disease affects mainly the skin and may have an impact on the muscles and bones. In systemic scleroderma, there is an involvement of the internal organs, such as the digestive tract, heart, lungs, and kidneys, among others. The severity and outcome of scleroderma are variable.

Three primary mechanisms contribute to the development of the scleroderma: vascular anomalies, excess fibrosis, and autoimmune phenomenon. Abnormal interactions between endothelial cells, fibroblasts, and lymphocytes (B and T) lead to microcirculatory vascular involvement. The endothelial cells produce large amounts of endothelin 1, causing vasoconstriction and fibroblast activation. Also, fibroblasts and activated endothelial cells produce reactive oxygen species that speed up vascular remodeling, leading to the obliteration of small vessels. Activated fibroblasts differentiate easily into myofibroblasts, which have increased collagen synthesis ability.

Treatment aims to relieve symptoms and to slow disease progression. No treatment can cure the disease. Therapeutic strategies should have their basis on a person’s symptoms and the need to prevent complications. The use of different immunosuppressive drugs remains disappointing. Immunosuppressive therapy is reserved for diffuse SSc of recent diagnosis (less than 3 to 5 years) and patients with progressive PID. Its basis is on induction with cyclophosphamide then a relay by mycophenolate mofetil. ACE inhibitors have a significant place in the treatment of renal crisis but they are not recommended as prevention. As for other forms of PAH, scleroderma-associated PAH may be treated with drugs designed to relax the walls of the pulmonary arteries, or vasodilation. Oxygen therapy and anticoagulants may be useful. Diuretics can help reduce swelling. Corticosteroids may be useful in certain inflammatory manifestations of the disease as inflammatory joint manifestations and inflammatory myopathies. High doses of corticosteroids may induce scleroderma renal crisis.

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

Scleroderma Emerging Drugs Chapters

This segment of the Scleroderma 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.

Scleroderma Emerging Drugs

FT011: Certa Therapeutics

FT011 is a novel drug that inhibits this GPCR, offering the potential to treat chronic fibrosis in multiple organs. Breakthrough research conducted by Certa Therapeutics has identified a novel biologic target in the fibrosis mechanism as a defined G protein-coupled receptor (GPCR). This GPCR is silent in healthy tissue but activates following injury or disease. Evidence demonstrates the role this GPCR has in multiple downstream pathways causing inflammation and fibrosis. Currently, the drug is in the Phase II stage of its development for the treatment of scleroderma.

EHP 101: Emerald Health Pharmaceuticals

EHP-101 is an oral formulation of a new chemical entity derived from synthetic cannabidiol, also known as CBD, one of the most abundant molecules found in the cannabis plant. The fully synthetic novel molecule formulated in EHP-101 has been rationally designed to enhance the therapeutic benefits of CBD by being a dual peroxisome proliferator-activated receptor gamma (PPARγ) and cannabinoid type 2 receptor (CB2) agonist that also activates the hypoxia inducible factor (HIF) pathway. The drug is currently in the Phase II stage of its development for the treatment of scleroderma.

ACE-1334: Acceleron Pharma

ACE-1334 is an Acceleron-discovered, TGF-beta superfamily-based ligand trap designed to bind and inhibit TGF-beta 1 and 3 ligands but not TGF-beta 2. TGF-beta 1 and 3 are believed to be key signaling factors in the pathogenesis of fibrotic disease. ACE-1334 has shown robust anti-fibrotic activity in multiple preclinical models of fibrosis. ACE-1334 completed an ascending-dose Phase I clinical trial in healthy volunteers. The FDA has granted Fast Track designation to ACE-1334 in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) as well as Orphan Drug designation for the treatment of systemic sclerosis. In November 2021, Merck announced the successful completion of the acquisition of Acceleron Pharma. Currently, the drug is in the Phase I stage of its development for the treatment of systemic scleroderma.

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

Scleroderma: Therapeutic Assessment

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

Major Players in Scleroderma

There are approx. 45+ key companies which are developing the therapies for Scleroderma. The companies which have their Scleroderma drug candidates in the most advanced stage, i.e. phase III include, Certa Therapeutics.

Phases

DelveInsight’s report covers around 50+ 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

Scleroderma 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.

Scleroderma: Pipeline Development Activities

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

Scleroderma Report Insights

Scleroderma Pipeline Analysis

Therapeutic Assessment

Unmet Needs

Impact of Drugs

Scleroderma 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 Scleroderma drugs?

How many Scleroderma drugs are developed by each company?

How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Scleroderma?

What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Scleroderma 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 Scleroderma and their status?

What are the key designations that have been granted to the emerging drugs?

Key Players

Biocad

Certa Therapeutics

Emerald Health Pharmaceuticals

Acceleron Pharma

Kyowa Kirin

Bayer

Boehringer Ingelheim

Maruho Co., Ltd.

Mitsubishi Tanabe Pharma

Prometheus Biosciences

Key Products

FT011

EHP 101

ACE-1334

Riociguat

Divozilimab

BI 685509

KHK4827

Nemolizumab

MT-7117

PRA023