Nontuberculous Mycobacterial Infections Pipeline Insight

DelveInsight’s, “Nontuberculous mycobacterial (NTM) Infections-Pipeline Insight, 2020,” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Nontuberculous mycobacterial Infections 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

Nontuberculous mycobacterial Infections Understanding

Nontuberculous mycobacterial Infections: Overview

Nontuberculous mycobacterial (NTM) lung disease is a general term for a group of disorders characterized by exposure to specific bacterial germs known as mycobacteria. These germs are found in the water and soil and are common throughout the environment as a whole. They usually do not cause illness. The term ‘nontuberculous’ is used to differentiate these disorders from the mycobacterium that cause tuberculosis (i.e. mycobacterium tuberculosis complex).

Symptoms

The symptoms and severity can vary greatly from one person to another. The reason for this variability is not fully understood. Chronic lung infection is the most common complication affecting approximately 94% of individuals. The symptoms are usually nonspecific and similar to the symptoms seen in other lung or respiratory infections. Such symptoms include cough, fatigue, shortness of breath (dyspnea), coughing up of blood (hemoptysis), excessive mucus (sputum) production, fever, night sweats, loss of appetite, and unintended weight loss. Wheezing and chest pain may also occur. Affected individuals may experience recurrent respiratory infections. In some cases, these infections can cause progressive damage to the lungs and, eventually, the lungs will not function as well as they should (impaired lung function).

Diagnosis

A diagnosis of nontuberculous mycobacterial lung disease is based upon identification of characteristic symptoms, a detailed patient history, a thorough clinical evaluation and a variety of specialized tests. However, the diagnosis can be challenging because the characteristic signs and symptoms are highly variable and nonspecific. A diagnosis of NTM includes ruling out other diseases such as tuberculosis or lung cancer.  

Treatment

Treatment with a combination of antibiotic drugs (drug regimen) is the mainstay of therapy for these diseases. However, these drugs carry certain risks (side effects) and are often poorly tolerated, have a high cost, and require individuals to remain on the medications for a lengthy period of time. These risks must be weighed against the potential benefits for each individual based upon the severity of their disease and specific symptoms that are present. If a decision is made not to treat, then an affected individual should be closely monitored to promptly detect any progression of the infection.

Nontuberculous mycobacterial Infections Emerging Drugs Chapters

This segment of the Nontuberculous mycobacterial Infections 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.

Nontuberculous mycobacterial Infections Emerging Drugs

  • Molgradex: Savara Pharma

Molgradex is an inhaled formulation of recombinant human GM-CSF. The benefit of GM-CSF is that it is not an antibiotic, as many bacterial species are becoming resistant to antibiotics it stimulates the human immune system without targeting the bacteria directly, which bypasses the problem of antibiotic resistance. It is in phase II trials for treating NTM infections along with NTM in cystic fibrosis. The company awaits the trial results from both of these studies.


  • RHB-204: Red Hill BioPharma

RHB-204 is a combination antibiotic therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. If it gets approval then, may be used as a first line of treatment for Pulmonary NTM infections caused by MAC. RedHill is planning, subject to regulatory approvals, to initiate a pivotal Phase 3 study with RHB-204 for a first-line, stand-alone treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC).


  • CYT107: RevImmune

CYT107 is a therapeutic form of the master growth factor for human T cells: Interleukin-7 (IL-7). CYT107 has been administered to over 440 patients in clinical trials and is known to substantially increase the number and diversity of T cells, including in patients in the ICU with low and exhausted T cell levels from overwhelming infections. CYT107 has an excellent safety profile, even in very sick patients.

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

Nontuberculous mycobacterial Infections: Therapeutic Assessment

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


  • Major Players in Nontuberculous mycobacterial Infections

There are approx. 15+ key companies which are developing the therapies for Nontuberculous mycobacterial Infections. The companies which have their Nontuberculous mycobacterial Infections drug candidates in the most advanced stage, i.e. phase II include, Savara Pharma, Red Hill BioPharma, RevImmune.

 Phases

DelveInsight’s 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


Nontuberculous mycobacterial Infections 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
  • Parenteral
  • Inhalation
  • Topical.
  • Molecule Type


Products have been categorized under various Molecule types such as

  • Vaccines
  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy
  • Product Type

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

Nontuberculous mycobacterial Infections: Pipeline Development Activities

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

Report Highlights

  • The companies and academics are working to assess challenges and seek opportunities that could influence Nontuberculous mycobacterial Infections R&D. The therapies under development are focused on novel approaches to treat/improve Nontuberculous mycobacterial Infections.
  • In January 2017, RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of Nontuberculous Mycobacteria (NTM) Infection.
  • In June 2019, RedHill Biopharma announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a new patent covering RHB-104 for Crohn’s disease and RHB-204 for Mycobacterium avium complex (MAC) disease, the most common cause of pulmonary nontuberculous mycobacteria (NTM) infections1. Once granted, the patent is expected to be valid until at least 2029.
  • In June 2016, Savara Pharmaceuticals announced that the company had acquired the assets of Serendex Pharmaceuticals adding two new programs to its pipeline. 

Nontuberculous mycobacterial Infections Report Insights

  • Nontuberculous mycobacterial Infections Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

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

Key Players

  • Savara Pharma
  • Red Hill BioPharma
  • RevImmune
  • Mallinckrodt
  • Insmed Incorporated
  • Novoteris
  • Beyond Air
  • Spero Therapeutics
  • Crestone
  • Qrumpharma

Key Products

  • Molgradex
  • RHB-204
  • CYT107
  • QRM-003
  • CRS400226
  • SPR 720

 

Introduction

Executive Summary

Nontuberculous mycobacterial Infections: Overview

• Causes

• Mechanism of Action

• Signs and Symptoms

• Diagnosis

• Disease Management

Pipeline Therapeutics

• Comparative Analysis

Therapeutic Assessment

• Assessment by Product Type

• Assessment by Stage and Product Type

• Assessment by Route of Administration

• Assessment by Stage and Route of Administration

• Assessment by Molecule Type

• Assessment by Stage and Molecule Type

Nontuberculous mycobacterial Infections – DelveInsight’s Analytical Perspective

In-depth Commercial Assessment

• Nontuberculous mycobacterial Infections companies’ collaborations, Licensing, Acquisition -Deal Value Trends

Nontuberculous mycobacterial Infections Collaboration Deals

• Company-Company Collaborations (Licensing / Partnering) Analysis

• Company-University Collaborations (Licensing / Partnering) Analysis

Mid Stage Products (Phase II)

• Comparative Analysis

Molgradex: Savara Pharma

• Product Description

• Research and Development

• Product Development Activities

RHB 204: RedHill Biopharma

• Product Description

• Research and Development

• Product Development Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

• Comparative Analysis

SPR 720: Spero Therapeutics

• Product Description

• Research and Development

• Product Development Activities

Drug profiles in the detailed report…..

Pre-clinical and Discovery Stage Products

• Comparative Analysis

CRS400226: Crestone

• Product Description

• Research and Development

• Product Development Activities

QRM-003: Qrumpharma

• Product Description

• Research and Development

• Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

• Comparative Analysis

Nontuberculous mycobacterial Infections Key Companies

Nontuberculous mycobacterial Infections Key Products

Nontuberculous mycobacterial Infections- Unmet Needs

Nontuberculous mycobacterial Infections- Market Drivers and Barriers

Nontuberculous mycobacterial Infections- Future Perspectives and Conclusion

Nontuberculous mycobacterial Infections Analyst Views

Nontuberculous mycobacterial Infections Key Companies

Appendix

List of Tables

 Table 1 Total Products for Nontuberculous mycobacterial Infections

Table 2 Late Stage Products

Table 3 Mid Stage Products

Table 4 Early Stage Products

Table 5 Pre-clinical & Discovery Stage Products

Table 6 Assessment by Product Type

Table 7 Assessment by Stage and Product Type

Table 8 Assessment by Route of Administration

Table 9 Assessment by Stage and Route of Administration

Table 10 Assessment by Molecule Type

Table 11 Assessment by Stage and Molecule Type

Table 12 Inactive Products

List of Figures

Figure 1 Total Products for Nontuberculous mycobacterial Infections

Figure 2 Late Stage Products

Figure 3 Mid Stage Products

Figure 4 Early Stage Products

Figure 5 Preclinical and Discovery Stage Products

Figure 6 Assessment by Product Type

Figure 7 Assessment by Stage and Product Type

Figure 8 Assessment by Route of Administration

Figure 9 Assessment by Stage and Route of Administration

Figure 10 Assessment by Molecule Type

Figure 11 Assessment by Stage and Molecule Type

Figure 12 Inactive Products

• Savara Pharma

• Red Hill BioPharma

• RevImmune

• Mallinckrodt

• Insmed Incorporated

• Novoteris

• Beyond Air

• Spero Therapeutics

• Crestone

• Qrumpharma


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