Pulmonary Fibrosis - Pipeline Insight, 2024

This “Pulmonary Fibrosis - Pipeline Insight, 2024” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Pulmonary Fibrosis 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

Pulmonary Fibrosis: Understanding

Pulmonary Fibrosis: Overview

Pulmonary Fibrosis is defined as “llifelong serious condition in which lungs become scarred and breathing becomes difficult and affect the respiratory system”. It is mostly seen in people of above age group 50. Due to this disease lung tissues gets thickened. It is usually a progressive disease with a poor long-term prognosis. Idiopathic pulmonary fibrosis is the most common type of interstitial lung disease.

The symptoms of this disease includes shortness of breath, especially during or after physical activity, chronic dry cough, fatigue and weakness, chest discomfort or pain, unexplained weight loss, loss of appetite, clubbing (widening and rounding) of the tips of the fingers or toes, environmental factors like smoking, chronic aspiration, or viral infections.

Pulmonary fibrosis affects approximately 100,000 people in the United States. Pulmonary fibrosis can occur at any age but is most commonly diagnosed in people aged 50 to 70. Environmental and occupational exposures, such as to silica dust or asbestos, can increase the risk of developing pulmonary fibrosis. There is currently no cure for pulmonary fibrosis, but treatments can help manage symptoms and slow disease progression.

The pathogenesis of pulmonary fibrosis involves the abnormal and excessive deposition of collagen and other extracellular matrix components in the lung interstitium. This process is driven by persistent epithelial injury and dysregulated wound healing, leading to the activation of fibroblasts and myofibroblasts. The exact mechanisms are complex and multifactorial, often involving genetic predisposition, environmental factors, and immune system dysregulation.

Diagnosis of pulmonary fibrosis typically involves a combination of clinical evaluation, imaging, and functional tests. High-resolution computed tomography (HRCT) scans of the chest are crucial for identifying the characteristic patterns of lung scarring. Pulmonary function tests assess lung capacity and function. In some cases, a lung biopsy may be needed to confirm the diagnosis and determine the specific type of fibrosis. Blood tests and assessments for underlying conditions or potential causes are also often conducted.

Pulmonary function tests every 3 to 6 months should be performed based on symptoms and the disease's progression. However, serial chest imaging is not always necessary. Tools like GAP (gender, age physiology) score issue points for the male gender, advanced age, forced vital capacity, and diffusing capacity or transfer factor of the lung for carbon monoxide and can be used to assess long-term prognosis, with a high GAP score indicating worse mortality. This is mainly used when considering a patient for a lung transplant referral. It is also important to assess the patient's functional status objectively and screen for hypoxic respiratory failure. Most Interstitial Lung Disease specialty centers use the 6-minute walk test to accomplish both. The treatment includes supportive measures, oxygen supplementation when needed, anti-fibrotic drugs, and lung transplants for severe disease. Pulmonary rehabilitation programs can improve physical conditioning and breathing efficiency. In advanced cases, lung transplantation may be considered.

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

Pulmonary Fibrosis Emerging Drugs Chapters

This segment of the Pulmonary Fibrosis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III 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.

Pulmonary Fibrosis Emerging Drugs

BI 1015550: Boehringer Ingelheim

Nerandomilast (BI 1015550) is an oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being investigated as a potential treatment for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Nerandomilast (BI 1015550) represents the first molecule in a new class of PDE4B inhibitors. The drug candidate has been granted Breakthrough Therapy and Orphan Drug Designations idiopathic pulmonary fibrosis by US FDA. The drug is currently being investigated in the Phase III stage of development for the treatment of Pulmonary Fibrosis.

AK3280: Ark Biosciences Inc

AK3280 is a next-generation broad-spectrum anti-fibrotic drug for the treatment of idiopathic pulmonary fibrosis (IPF) and is undergoing a randomized, double-blind, multicenter phase 2 PoC clinical study. The clinical trial led by Professor Huaping Dai of the China-Japan Friendship Hospital, Beijing, is being conducted across 31 hospitals in China to evaluate the safety, tolerability, and efficacy of AK3280 in IPF patients. The drug is currently being investigated in the Phase II stage of development for the treatment of Pulmonary Fibrosis.

ARO-MMP7: Arrowhead Pharmaceuticals

ARO-MMP7, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce the expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF). AROMMP7-1001 is a Phase I/IIa single ascending dose and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MMP7 in up to 56 healthy volunteers and up to 21 patients with IPF. The drug is currently being investigated in the Phase I/II stage of development for the treatment of Pulmonary Fibrosis.

RSBT 001: RS BioTherapeutics

(RSBT-001) is a first-in-class therapeutic in development as an alternative to corticosteroids for the treatment of respiratory diseases characterized by pulmonary inflammation including COPD, Idiopathic Pulmonary Fibrosis, Pulmonary Arterial Hypertension, and others. RSBT-001 reduces pulmonary inflammation by harnessing the immune modulating power of specific, anti-inflammatory cannabinoids and targeting the inflammatory cascade in the lungs at multiple levels. RS BioTherapeutics is targeting an IND filing for RSBT-001 in 2026. The drug is currently being investigated in the Preclinical stage of development for the treatment of Pulmonary Fibrosis.

Pulmonary Fibrosis: Therapeutic Assessment

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

Major Players in Pulmonary Fibrosis

There are approx. 70+ key companies which are developing the therapies for Pulmonary Fibrosis. The companies which have their Pulmonary Fibrosis drug candidates in the most advanced stage, i.e. Phase III include,

Phases

The report covers around 75+ 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

Pulmonary Fibrosis 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.

Pulmonary Fibrosis: Pipeline Development Activities

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

Pulmonary Fibrosis Report Insights

• Pulmonary Fibrosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Boehringer Ingelheim
• Bristol-Myers Squibb
• Ark Biosciences Inc
• Regend Therapeutics
• Arrowhead Pharmaceuticals
• RS BioTherapeutics
• BreStem Therapeutics
• Foresee Pharmaceuticals
• AnBogen Therapeutics
• Alkermes plc
• InSilico Medicine
• Overseas Pharmaceuticals
• AstraZeneca
• Indalo Therapeutics

Key Products

• BI 1015550
• BMS-986278
• AK3280
• REGEND001
• ARO-MMP7
• RSBT 001
• BRS 302
• FP-020
• ABT 301
• ALKS-8700
• ISM001 055
• Pirfenidone
• Saracatinib
• IDL 2965

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