Non-cystic fibrosis bronchiectasis - Pipeline Insight, 2024

This “Non‐cystic fibrosis bronchiectasis - Pipeline Insight, 2024” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Non‐cystic fibrosis bronchiectasis 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

Non‐cystic fibrosis bronchiectasis: Understanding

Non‐cystic fibrosis bronchiectasis: Overview

Non-cystic fibrosis (non-CF) bronchiectasis (henceforth referred to as bronchiectasis) is a progressive respiratory disease characterized by a permanent dilation of bronchi, retention of mucus, and ciliary clearance impairment. Clinical features include chronic daily sputum, cough, shortness of breath, and recurrent respiratory infections, with consequent increased morbidity and worsened quality of life. One of the cornerstones in the management of bronchiectasis is the identification and treatment of underlying causes.

Cole's “vicious cycle” of infection, airway inflammation and lung damage is the most widely accepted mechanism for the development of NCFB. The cycle is triggered when the defense system of the lung is breached and mucociliary clearance is impaired. Potential causes of this breach include severe lower respiratory tract infections, gastric aspiration, and/or inhalation of toxic gases. Other inflammatory processes may be associated with local and systemic inflammation that leads to changes in the architecture of the bronchial airways. However, a clear trigger is not identified in up to 30%‐53% of patients. Regardless of the cause, when mucociliary clearance is impaired, mucous is retained in the airways.

This in turn leads to microbial colonization or infection with a subsequent development of an inflammatory response. As the host fails to eliminate the persistent infection, airway inflammation becomes chronic. Both host inflammatory responses and microbial cytotoxins cause additional structural damage to the lung and further impair mucus clearance; thus, the vicious cycle persists. Some microorganisms, such as Pseudomonas aeruginosa, may form biofilms in the bronchial airways. Biofilms are thin layers that form on colonized surfaces and are typically comprised of bacteria and a matrix of an extracellular polymeric substance that includes polysaccharides, proteins, and DNA.

This may facilitate the persistence of the “vicious cycle” of bronchiectasis because the biofilms protect bacteria from clearance by the host immune system and reduce the effects of antibiotics, further potentiating airway inflammation. Disruption of the biofilms by some antibiotics (i.e., macrolides) is thought to be one of the mechanisms by which chronic antibiotic therapy may improve outcomes in bronchiectasis.

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

Non‐cystic fibrosis bronchiectasis Emerging Drugs Chapters

This segment of the Non‐cystic fibrosis bronchiectasis 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.

Non‐cystic fibrosis bronchiectasis Emerging Drugs

Brensocatib: Insmed Incorporated

Brensocatib (INS1007 or AZD7986) is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation.

Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Insmed acquired the license for the treatment from AstraZeneca in 2016. Currently, the drug is in Phase III stage of its clinical trial evaluation for the treatment of Non‐cystic fibrosis bronchiectasis.

HSK31858: Haisco Pharmaceutical Group Co., Ltd.

HSK31858 tablet is an oral, potent, and highly selective dipeptidyl peptidase 1 (DPP1) small molecule inhibitor independently developed by the Haisco Pharmaceutical. The main mechanism of action is that inhibiting DPP1 can inhibit the activation of neutrophils and the release of neutrophils to the circulatory system by inhibiting the activation of neutrophil NSP enzymes.

It is clinically intended to be used for the treatment of lower respiratory tract diseases caused by bronchiectasis and acute lung injury/acute respiratory distress syndrome. The drug has completed phase I clinical trials in Australia and China, and now the phase II clinical trials of the project have completed the enrollment and administration of the first subject, and the project is progressing smoothly.

CSL 787: CSL Behring

CSL 787, is a human plasma-derived immunoglobulin for administration via a nebulizer for the potential prevention of chronic respiratory tract infections and progression of chronic lung disease such as Non‐cystic fibrosis bronchiectasis (NCFB). Currently, the drug is being developed in the Phase I stage of Clinical trial evaluation for the treatment of Non‐cystic fibrosis bronchiectasis.

Non‐cystic fibrosis bronchiectasis: Therapeutic Assessment

This segment of the report provides insights about the different Non‐cystic fibrosis bronchiectasis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Non‐cystic fibrosis bronchiectasis

There are approx. 15+ key companies which are developing the therapies for Non‐cystic fibrosis bronchiectasis. The companies which have their Non‐cystic fibrosis bronchiectasis drug candidates in the most advanced stage, i.e. phase III include, Insmed Incorporated.

Phases

The 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

Non‐cystic fibrosis bronchiectasis 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
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

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

Non‐cystic fibrosis bronchiectasis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Non‐cystic fibrosis bronchiectasis 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 Non‐cystic fibrosis bronchiectasis drugs.

Non‐cystic fibrosis bronchiectasis Report Insights

• Non‐cystic fibrosis bronchiectasis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Zambon SpA
• Insmed Incorporated
• NovaBiotics
• Haisco Pharmaceutical Group
• Armata Pharmaceuticals
• Chiesi Farmaceutici
• CSL Behring

Key Products

• Colistimethate sodium
• Brensocatib
• HSK31858
• CHF 6333
• CSL 787
• AP-PA02
• ARINA-1

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