Nontuberculous Mycobacterial Infections - Pipeline Insight, 2024

This “Nontuberculous Mycobacterial Infections- Pipeline Insight, 2024” report provides comprehensive insights about 10+ companies and 10+ 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) infections are caused by mycobacteria that are not part of the Mycobacterium tuberculosis complex or Mycobacterium leprae. These organisms are ubiquitous in the environment, found in soil, water, and dust, and they can cause a wide range of infections, particularly in individuals with compromised immune systems or pre-existing lung conditions. NTM infections are becoming increasingly recognized as a significant health concern, particularly in developed countries.

The symptoms of NTM infections vary depending on the site of infection but commonly include chronic cough, fatigue, weight loss, and hemoptysis (coughing up blood) when the lungs are involved. Other potential symptoms include lymphadenitis (swollen lymph nodes), skin lesions, and soft tissue abscesses. Pulmonary NTM infections are the most common, especially among individuals with chronic lung diseases like chronic obstructive pulmonary disease (COPD), bronchiectasis, or cystic fibrosis.

NTM infections occur when these bacteria are inhaled or enter through broken skin, but unlike tuberculosis, they are not usually spread from person to person. The pathophysiology involves the mycobacteria entering the host and evading the immune system, leading to persistent infection. NTM organisms can form biofilms and persist in macrophages, making them difficult to eradicate. The risk of infection increases in people with weakened immune systems, such as those with HIV/AIDS, or individuals on immunosuppressive therapies.

Diagnosis of NTM infections involves a combination of clinical, radiological, and microbiological assessments. Clinical suspicion is raised based on symptoms and risk factors. Imaging, such as chest X-rays or CT scans, may show characteristic findings like nodules, bronchiectasis, or cavitary lesions. Definitive diagnosis is made by isolating the NTM organism from sputum or other body fluids/tissues through cultures. Molecular methods, like PCR, can also be used for species identification.

Treatment of NTM infections is challenging and often requires prolonged antibiotic therapy, typically spanning 12 months or more. The choice of antibiotics depends on the specific NTM species and the patient's overall health. Commonly used antibiotics include macrolides (such as clarithromycin or azithromycin), rifamycins (such as rifampin), and ethambutol. In some cases, surgical intervention may be necessary to remove infected tissue. Managing NTM infections also involves addressing underlying conditions and improving immune function to enhance the chances of successful treatment.

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

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

MNKD-101: Mannkind Corporation

MNKD-101 (Clofazimine) is being developed as an inhalation treatment option for nontuberculous mycobacterial (NTM) lung disease. NTM lung disease is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life. It is estimated that approximately 86,000 people in the U.S. are living with NTM lung disease. MNKD-101 has been designated by the FDA as both an orphan lung and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. U.S. Food and Drug Administration (FDA) has granted Fast Track designation of Clofazimine Inhalation Suspension (MNKD-101) for the treatment of nontuberculous mycobacterial (NTM) lung disease. Currently, the drug is in Phase III stage of its development for the treatment of Nontuberculous Mycobacterial Infections.

MAT2501: Matinas BioPharma

MAT2501 is an orally-administered Lipid Nano-Crystal formulation of the gram-negative antibiotic agent, amikacin. The drug is in Phase I clinical development for the treatment of Nontuberculous Mycobacteria (NTM) Infections. As a broad-spectrum aminoglycoside, amikacin is highly effective in treating a range of chronic and acute bacterial infections, including Non-Tuberculous Mycobacterium (NTM) infections. FDA designated MAT2501 as a QIDP and Orphan Drug for the treatment of NTM infections. Currently, the drug is in Phase I stage of its development for the treatment of Nontuberculous Mycobacterial Infections.

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. 10+ 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 III include, Mannkind Corporation.

Phases

DelveInsight’s report covers around 10+ 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
• 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.

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.

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

• Mannkind Corporation
• Matinas BioPharma
• Spero Therapeutics
• Crestone, Inc
• Vast Therapeutics

Key Products

• MNKD-101
• MAT2501
• SPR720
• CRS0393
• ALX1

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