Bronchiolitis Obliterans Syndrome - Pipeline Insight, 2021

This “Bronchiolitis Obliterans Syndrome (BOS) - Pipeline Insight, 2021,” report provides comprehensive insights about 5+ companies and 10+ pipeline drugs in Bronchiolitis Obliterans Syndrome (BOS) 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

Bronchiolitis Obliterans Syndrome (BOS) Understanding

Bronchiolitis Obliterans Syndrome (BOS): Overview

Bronchiolitis obliterans syndrome is a form of chronic lung allograft dysfunction that affects the majority of lung transplant recipients. It is the principal factor limiting long-term transplant survival. BOS is characterized by progressive airflow obstruction unexplained by acute rejection, infection, or other coexistent condition. Although BOS is a proven useful clinical syndrome that identifies patients at increased risk for death, its clinical course and underlying causative factors are now recognized to be increasingly heterogeneous.

Symptoms

Symptoms generally progress slowly over weeks to months. Common symptoms include:

• Shortness of breath and/or wheezing
• Decreased exercise or activity tolerance and endurance
• Fatigue
• Dry Cough

Causes
Bronchiolitis obliterans may result from lung injury caused by a variety of different chemicals and respiratory infections. Inhaled chemicals known to irritate the lungs and lead to the condition include chlorine; ammonia; oxides of nitrogen or sulfur dioxide; welding fumes; or food flavoring fumes (such as diacetyl). Respiratory infections caused by a respiratory syncytial virus, adenovirus, or Mycoplasma pneumonia have been linked with the condition.

Pathogenesis
A better understanding of BOS pathogenesis is important if rational strategies are to be developed for its management. The histopathological features of BO suggest that injury and inflammation of epithelial cells and subepithelial structures of small airways lead to excessive fibro-proliferation due to ineffective epithelial regeneration and aberrant tissue repair. To support the basis for the pathogenesis of BOS two hypotheses have been proposed by several studies to explain the pathogenesis of chronic rejection which is alloimmune and non-alloimmune mechanisms.

Treatment

Bronchiolitis Obliterans Syndrome (BOS) remains the major problem which ceases long-term survival after lung transplantation. Treatment and prevention of BOS are quite challenging. Currently, there is no approved or standard treatment for BOS and successful treatment is defined as stabilization or reduction in the rate of FEV1 decline. An important focus of treatment of BOS patients is optimizing immunosuppression to prevent further lung allograft rejection. Current treatment consists primarily of augmenting immunosuppression by changing medications within therapeutic classes, by adding medications, or by applying non-medicinal immuno-modulating therapies. An increasing number of induction and maintenance immunosuppressive agents have become available over time for use in various combinations allowing for more choice and personalization of immunosuppressive therapy. Despite several advancements, there are pros and cons to each immunosuppressive agent and a regimen that leads to prolonged survival yet is void of associated morbidity including infection, malignancy, and drug-related toxicities, etc. are still under regress research and development.

Bronchiolitis Obliterans Syndrome (BOS) Emerging Drugs Chapters

This segment of the Bronchiolitis Obliterans Syndrome (BOS) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps 0410o understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Bronchiolitis Obliterans Syndrome (BOS) Emerging Drugs

Liposomal Cyclosporine A: Breath Therapeutics (a Zambon Company)

Breath Therapeutics a Zambon Group Company (a spin-off of PARI Pharma) is developing Liposomal Cyclosporine A for Inhalation (L-CsA-I; also known as Ciclosporin inhalation and Cyclosporine A Inhalation) as the first potential therapy for Bronchiolitis Obliterans Syndrome (BOS). It is the lead drug candidate and is a proprietary liposomal formulation of cyclosporine A for inhalation administered via a drug-specific investigational PARI Pharma's eFlow nebulizer, being designed for inhaled delivery to the lungs.

Pirfenidone: Genentech

Genentech is developing Pirfenidone, a pyridone small molecule, orally active, an antifibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions, including proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

Ruxolitinib: Incyte Corporation

Ruxolitinib (also known as INC-424; INCB 018424 phosphate; INCB-018424; INCB-18424; Jakafi; Jakavi and ruxolitinib phosphate) is a small molecule, first-in-class Janus kinase 1 (JAK1)/JAK2 inhibitor. It is developed and marketed by Incyte Corporation, indicated for the treatment of patients with intermediate or high-risk Myelofibrosis and for patients with Polycythemia Vera with inadequate response or intolerance of hydroxyurea.

The drug is approved by the brand name JAKafi in the United States and JAKavi by Novartis outside United States.

Itacitinib: Incyte Corporation

Itacitinib is an orally bioavailable inhibitor of Janus-associated kinase 1 (JAK1) with potential antineoplastic and immunomodulating activities. Upon oral administration, itacitinib selectively inhibits JAK-1, thereby inhibiting the phosphorylation of signal transducer and activator of transcription (STAT) proteins and the production of proinflammatory factors induced by other cytokines, including interleukin-23 (IL-23) and interleukin-6 (IL-6). It is currently in under phase 1/2 of clinical trials for condition- Bronchiolitis Obliterans Syndrome.

Bronchiolitis Obliterans Syndrome (BOS): Therapeutic Assessment

This segment of the report provides insights about the different Bronchiolitis Obliterans Syndrome (BOS) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Bronchiolitis Obliterans Syndrome (BOS)

There are approx. 10+ key companies which are developing the therapies for Bronchiolitis Obliterans Syndrome (BOS). The companies which have their Bronchiolitis Obliterans Syndrome (BOS) drug candidates in the mid to advanced stage, i. e. phase III and Phase II include, Incyte Corporation and others.

Phases

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

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

Bronchiolitis Obliterans Syndrome (BOS) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Inhalation
• Intravenous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Small molecules
• Proteins
• Product Type

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

• Mechanism of action

Products have been categorized under various MOA such as

• Calcineurin inhibitors (CNIs)
• Collagen inhibitors; Cytokine inhibitors
• Fbx3 protein inhibitors
• Interleukin-1 beta receptor antagonists
• JAK1/JAK2 inhibitor
• Janus kinase 1 inhibitors
• Neutrophil elastase inhibitor
• Product Type

Bronchiolitis Obliterans Syndrome (BOS): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Bronchiolitis Obliterans Syndrome (BOS) 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 Bronchiolitis Obliterans Syndrome (BOS) drugs.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Bronchiolitis Obliterans Syndrome R&D. The therapies under development are focused on novel approaches to treat/improve Bronchiolitis Obliterans Syndrome.
• In January 2020, Altavant Sciences acquired Onspira Therapeutics. The Company is intended to develop OSP-101 for the treatment of Bronchiolitis Obliterans Syndrome, the leading cause of morbidity and mortality in post-lung transplant patients.
• In May 2017, PARI Pharma gained Orphan Drug Designation for L CsA i for the treatment of BOS by the European Commission. L-CsA-i has also received Orphan Drug Designation from the FDA for the treatment of bronchiolitis obliterans.
• Breath Therapeutics' drug device platform consists of liposomal drug-aerosol formulations and cutting-edge inhalation technology. The basis for successful inhalation therapy is precise and fast drug delivery into the small airway of the lungs. This requires a uniquely designed drug formulation paired with a high-performance, drug-specific nebulizer.
• In August 2014, Roche and InterMune reach a definitive merger agreement in which Roche acquired InterMune for USD 74.00 per share. This corresponds to a total transaction value of US$ 8.3 billion on a fully diluted basis. This offer represents a premium of 38% to InterMune's closing price on 22 August 2014 and a premium of 63% to InterMune's unaffected closing price on 12 August 2014. The merger agreement has been approved by the boards of InterMune and Roche.
• In October 2017, Mereo BioPharma acquired an exclusive license for MPH-966 from AstraZeneca together with an option to acquire the IP based on certain milestones.

Bronchiolitis Obliterans Syndrome (BOS) Report Insights

• Bronchiolitis Obliterans Syndrome (BOS) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Bronchiolitis Obliterans Syndrome (BOS) Report Assessment

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

Key Questions Answered

Current Treatment Scenario and Emerging Therapies:

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

Key Players

• Breath therapeutics
• Genetech
• Incyte Corporation

Key Products

• Liposomal Cyclosporin A
• Pirfenidone
• Ruxolitinib
• Itacitinib

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