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protnveda therapeutics private limited

An enzyme based inhaler formulation for drug resistant TB

Detailed Description of the Enzyme-Based Innovation for Combating Drug-Resistant Mycobacterium tuberculosis

Overview

This innovation introduces a novel enzyme-based approach to address the global challenge of drug-resistant Mycobacterium tuberculosis (Mtb), the causative agent of tuberculosis (TB). The solution encompasses both therapeutic and diagnostic applications, leveraging a unique enzyme formulation that directly targets the robust mycolic acid-containing cell wall of Mtb. By destabilizing this critical barrier, the enzyme facilitates both enhanced drug delivery for treatment and simplified sample preparation for diagnostics, offering a potential breakthrough in combating multi-drug-resistant (MDR) and extensively drug-resistant (XDR) TB strains.

Therapeutic Innovation

Mechanism of Action

The enzyme-based therapy focuses on the direct degradation of the Mtb cell wall, specifically targeting the mycolic acid-containing outer membrane. This membrane, a hallmark of Mycobacterium species, provides a formidable barrier that contributes to the bacterium’s resistance to conventional antibiotics. The enzyme destabilizes this structure by enzymatically removing outer membrane-embedded porins, which are essential for nutrient uptake and bacterial survival. This disruption compromises the integrity of the cell wall, leading to bacterial lysis or increased susceptibility to other drugs.

When used in combination with existing TB drugs, the enzyme enhances drug diffusion into the bacterial cell by weakening the cell wall, allowing approved antibiotics to more effectively target intracellular components. This synergistic approach not only restricts bacterial proliferation but also limits further infection, offering a promising strategy to control drug-resistant TB.

Key Differentiators

The enzyme-based therapy stands out from existing TB treatments in several critical ways:

Target Specificity: Unlike conventional therapies that target bacterial metabolism, DNA synthesis, or ATP production, this enzyme directly attacks the mycolic acid membrane, bypassing common resistance mechanisms driven by genetic mutations.
Resistance Mitigation: By not relying on specific intracellular targets, the enzyme avoids resistance mechanisms that affect traditional drugs, making it particularly effective against MDR and XDR strains.
Delivery Mechanism: The therapy employs a nano-inhaler for targeted lung delivery, ensuring the enzyme reaches the primary site of TB infection efficiently. This contrasts with oral or injectable drugs used in existing treatments, which may face challenges in achieving sufficient concentrations in the lungs.
Reduced Toxicity: Preliminary evaluations suggest the enzyme has lower toxicity compared to the high-toxicity profiles of many existing TB drugs, which often require prolonged treatment durations.
Efficacy Against Resistant Strains: Early results indicate promising efficacy against drug-resistant Mtb strains, addressing a critical gap where current therapies are limited.

Research Objectives

The therapeutic development plan includes:

Characterization of Mechanism and Specificity: Detailed studies to understand the enzyme’s interaction with the Mtb cell wall and its specificity to avoid off-target effects.
Safety and Toxicity Evaluation: In-vitro studies to assess potential toxicity, ensuring the enzyme is safe for therapeutic use.
Efficacy Testing: Comprehensive testing against various Mtb strains, including MDR and XDR variants, to confirm efficacy.
Delivery Optimization: Exploration of nano-inhaler delivery systems and animal studies to validate targeted lung delivery and therapeutic outcomes.

Diagnostic Innovation

Addressing Diagnostic Challenges

Current TB diagnostics, particularly sputum-based molecular tests, face significant barriers, including the inability of some patients to produce sputum and the reliance on equipment-intensive mechanical lysis methods. These limitations restrict access to diagnostics in resource-limited settings. The enzyme-based approach offers a transformative solution by enabling sputum-free diagnostics through the use of tongue swabs and simplifying sample preparation.

Mechanism for Diagnostics

The enzyme disrupts the Mtb cell wall to release intracellular components, such as DNA, for diagnostic detection. This eliminates the need for complex mechanical lysis, reducing assay complexity and cost. The enzyme’s ability to destabilize the mycolic acid membrane ensures efficient sample preparation, making it compatible with molecular diagnostic techniques like PCR.

Research Objectives

The diagnostic development plan includes:

Mechanism and Specificity Characterization: Similar to the therapeutic arm, this objective focuses on understanding the enzyme’s action on the Mtb cell wall for diagnostic purposes.
Sample Preparation Optimization: Development of a DNAse-free sample preparation protocol, including optimization of storage buffer composition or protein engineering to ensure stability at room temperature, enhancing usability in low-resource settings.
Diagnostic PCR Optimization: Refinement of PCR protocols to maximize sensitivity and specificity when using enzyme-processed samples, ensuring reliable detection of Mtb.

Preliminary Results

The enzyme has been successfully tested on Mycobacterium smegmatis, a non-pathogenic model organism for Mtb, demonstrating effective cell wall disruption via spot diffusion assays. Additionally, specificity tests on E. coli strains (including K12 and expression strains) and human cell lines (A549, HEK, and CHO) showed no toxicity, indicating a favorable safety profile for both therapeutic and diagnostic applications.

Market Potential

The innovation targets two critical markets:

Drug-Resistant TB Treatment: With only 2 in 5 people with drug-resistant TB receiving treatment (WHO 2023), there is an urgent need for effective therapies against MDR and XDR strains. The enzyme-based therapy’s ability to bypass resistance mechanisms positions it as a game-changer in this space.
TB Diagnostics: The global TB diagnostics market demands accessible, cost-effective solutions. The enzyme’s compatibility with tongue swabs and simplified sample preparation addresses barriers to molecular diagnostics, particularly in regions with limited medical infrastructure.

Milestones

Expression and Purification: Successful production and purification of the enzyme, already achieved in preliminary studies.
Clinical Development: Ongoing and future studies to validate safety, efficacy, and delivery in preclinical and clinical settings.
Regulatory Approval: Pursuit of regulatory clearance for both therapeutic and diagnostic applications.
Commercialization and Post-Market Surveillance: Development of commercialization strategies and monitoring of real-world performance post-launch.

Conclusion

This enzyme-based innovation represents a dual-purpose breakthrough in TB management, addressing both treatment and diagnostic challenges posed by drug-resistant Mycobacterium tuberculosis. By directly targeting the mycolic acid cell wall, the enzyme offers a novel mechanism to overcome resistance, enhance drug efficacy, and simplify diagnostics. With promising preliminary results and a clear development roadmap, this solution has the potential to transform TB care, particularly for vulnerable populations and in resource-limited settings.

Ostic Pharma Pvt Ltd

Next Generation Rapid TB LAM Test for Mass Screening of TB in Urine and Other Body Fluids.

TB is an infectious airborne disease, whose main etiologic agent is MTb. Although TB is present in every country in the world, this disease mainly affects low-income and vulnerable populations. TB is among the 10 leading causes of death in the world, and the first as an infectious agent in HIV Positive patients. In 2019, TB was responsible for over 1 million deaths. WHO estimates that one-fourth of the world's population is infected with MTb.

Presently existing LAM urine test (Alere, Abbott, USA) has higher sensitivity & specificity, mainly in HIV co-infected TB patients, while its sensitivity and specificity are very less in active TB patients 17-40% average 26 percentage. We propose an improved version of a visual, qualitative, rapid, and affordable test (LAM-Based TB test) for mass screening of TB in urine. Tests are rapid, and results can be interpreted in 10 minutes. The proposed tests are suitable for doctors’ clinics and resource-constrained areas, and no refrigeration is required during storage and transportation. Lipoarabinomannan (LAM) is a potential marker of active tuberculosis (TB). The test is based on the detection of mycobacterial lipoarabinomannan (LAM) antigen in body fluids (blood and sputum etc) that can be used as a potential point of care test for tuberculosis (TB). LAM antigen is a lipopolysaccharide present in mycobacterial cell walls, which is released from metabolically active or degenerating bacterial cells and appears to be present only in people with active TB disease.

Urine-based testing would have advantages over sputum-based testing because urine is easy to collect and store, and lacks the infection control risks associated with sputum collection. This rapid Test is a membrane-based test for the rapid detection of cell wall antigen in urine. Our proposed TB test (detection of antigen in Urine) is rapid (20-25 minutes compared to 8 to 12 weeks for routine culture), low cost and affordable (compared to USD20 for Gene Xpert), do not require equipment, they are point of care easy to use tests and only small amount of sample is needed for the test. The tests can be performed in rural and resource settings where pathology labs or TB labs are not available.

We have completed clinical validation of Rapid Tests in urine samples of TB and HIV co-infected TB patients at one site (Fiocruz, Recife, Brazil) under the BRICS Project. As a result, we found higher accuracy than Alere LAM (Abbott) and FujiLAM (Japan) TB tests. Further, investigations and validation studies are going on in Fiocruz, Rio De Janeiro, Brazil to increase its accuracy and make it suitable for mass screening of TB in adult as well as pediatric TB populations in rural and resource-constrained areas of India, China, Brazil, and South Africa (High Burden Countries).

All India Institute Of Medical Sciences (AIIMS) - Raipur-C.G- India

Highly Oxygenated Aerosol Controlled (HOAC) Combo Device For COVID-19 and Airborne Diseases (TB).

A multifunctional, non-electronic, disposable respiratory device designed for safer TB and airborne disease management through infection control, improved lung therapy, and efficient sputum collection—especially suited for primary care and high-burden settings.

Key Specifications and Functionalities

Non-Electronic: Does not require power; fully mechanical.
Single-Use & Disposable: Designed for infection prevention in resource-limited or high-risk settings.
Closed-System Design: Prevents aerosol escape using smart physics-based airflow control with dry sponge filtration.
Modular 5-in-1 Functionality:
Nebulization – Contained aerosol delivery for pulmonary drugs.
Incentive Spirometry – Supports lung recovery post-infection.
Active Sputum Sampling – Enables safe sputum collection without aerosol spread.
Non-Rebreather Oxygen Mask – Ensures high-concentration oxygen delivery.
Standard Oxygen Face Mask – Basic oxygen therapy function.

Utility for TB Management

Sputum Collection: Enables safe and effective sputum sample collection with aerosol containment—critical for TB diagnosis.
Infection Control: Reduces airborne transmission risk during aerosol-generating procedures like nebulization or spirometry in TB patients.
Pulmonary Recovery: Supports post-treatment lung rehabilitation, especially for patients with pleural effusion or compromised lung function.
Safe Oxygen Therapy: Facilitates safer transport and oxygen delivery for TB patients, minimizing nosocomial infection risks.
Rural and PHC Use: Suitable for field deployment in high-TB-burden and low-infrastructure settings.

Deployment Potential

Use Environments: PHCs, CHCs, TB diagnostic centers, inpatient wards, and home-based care.
Stage of Development: Entering prototype development, clinical validation, and pilot scale-up.

Ruhvenile Biomedical OPC Pvt Ltd.

truGnom™

truGnom™ by Ruhvenile® Biomedical (www.ruhvenile.com) offers a transformative solution in the fight against tuberculosis (TB), addressing critical challenges in molecular diagnostics and research of any specimen.

Overcoming Limitations in TB Diagnostics

Modern molecular diagnostics, such as PCR, RT-PCR, NGS, and WGS, require high-quality, stable genetic material from diverse sample types. However, conventional transport and preservation media often face challenges, including microbial revival, cold chain dependency, and sample degradation, leading to unreliable results.

How truGnom™ Addresses These Challenges

Immediate Microbial Inactivation: truGnom™ neutralizes and lyses microbes upon collection, ensuring no further lysis is required for preserved samples. This immediate action prevents microbial revival and maintains sample integrity.
Enhanced Nucleic Acid Yield: The medium achieves a 2.5–3X increase in nucleic acid isolation from any specimen, compatible with a diverse range of commercially available DNA and RNA extraction kits.
Cold Chain Independence: truGnom™ eliminates the need for cold chain logistics for the first 72 hours post-collection, facilitating sample transport in resource-limited settings.
Long-Term Stability: It ensures long-term DNA/RNA stability for up to five years at -80°C, preserving the integrity of genetic materials for extended periods.

Impact on TB Research and Public Health

By providing a reliable and efficient medium for specimen transportation and preservation, truGnom™ enhances the accuracy of molecular diagnostics and research reproducibility. Its adoption can significantly improve diagnostic accuracy and research outcomes, contributing to global efforts to end TB.

Currently, all the above-mentioned 11 hospitals across India are using truGnom™ for immediate analysis and also genetic material preservation, followed by analysis of gallbladder tissue and associated specimens for deep and accurate analysis.

Dr LalPath lab also tested truGnom for their daily work and found it superior in terms of sample transportation, microbes’ inactivation, removing lyses step, accurate, reproducible, and reliable data. We are working with them to make a business deal.

We are ready to serve our indigenous patented product truGnom of any quantity if you want to adapt new technologies!

For more information on truGnom™ and its applications in TB diagnostics and research, please visit www.ruhvenile.com | info@ruhvenile.com | +91 8587033367 | +91 11 3501 7209

Fujifilm India Pvt Ltd

Low Xray Dose with excellent Diagnostic Image Quality

As a part of continuous innovation Fujifilm is pleased to introduce its state-of-the-art portable digital radiography solution FDR Xair. In combination with High sensitivity detector it ensures high image quality, low patient dose & ensures accurate diagnosis. FDR Xair supports vender neutral AI applications. FDR Xair is ideally suitable for radiology applications. This product meets all regulatory & quality norms which includes WHO guideline, AERB, CE, FDA etc. On top of this Fujifilm has the widest Global experience of handling TB Screening programs including India. In India we are proud to be a partner with NTEP initiative. In India we have participated in many TB screening programs & our screening model has been well appreciated & recommended at various level. Xair is handheld portable Xray approx. weight 3.5kg. Unique design like camera. Exclusive ISS Technology in the Detector to get high DQE & MTF with low Xray dose to patient. Own software with Dynamic Visualization II & Virtual grid further reduces the Xray dose and provide excellent Diagnostics Image quality.

SD BIOSENSOR HEALTHCARE PVT LTD

M10 MTB Diagnosis Platform

M10 MTB NTM is a cartridge based POC system for the differential detection MTB and NTM

AAGCC8708G

Enabling Technology for Bovine TB Control by BCG Vaccination and Point-of-Care LFA Kit for Herd Screening.

This study investigates methyl-beta-cyclodextrin (M-beta-CD) microparticles as a novel trans-nasal drug delivery platform for CNS-TB therapy. M-beta-CD enhances mucosal permeability and drug absorption by forming inclusion complexes with ATDs. We developed ATD-loaded M-beta-CD microparticles via spray drying technology and evaluated their physicochemical properties, in-vitro transport, and in-vivo therapeutic efficacy. The results demonstrated significantly improved CNS drug bioavailability, reduced neuroinflammation, and enhanced bacterial clearance in a murine CNS-TB model.Novelty and Advantages: The ATD-MP formulation enables efficient drug delivery to the brain while reducing systemic side effects. The optimized 5-6 micron microparticles ensure efficient nasal deposition (more than 80 percent emitted dose), biphasic drug release, and sustained therapeutic action.

Jubilant Bhartia Foundation

TB IVRS Model

To contribute towards the national goal of TB Free India through technological intervention, Jubilant Bhartia Foundation has developed a TB monitoring software system. The technology is developed in partnership with Indev Consultancy a software company.

The system allows

Effective Monitoring on daily basis
Daily record of patients who received calls or did not receive calls
Automated daily calls to patients for taking medicine
Patient details of those whose medicines have run out
Location data of patients for proper mapping to deliver nutrition kits
Regular engagement with such patients for awareness session

Mylab Discovery Solutions

PathoDetect PCR Kits with Resistance Detection

PathoDetect PCR Kits with Resistance Detection: The PathoDetecte2201ea2 kit, combined with the Mylab Compact device platform, addresses gaps in tuberculosis testing. The PathoDetect MTB RIF & INH Resistance Detection Kit provides comprehensive testing by detecting MTB, INH, and RIF resistance in a single test, ensuring efficient patient diagnosis. Endorsed by CDSCO, National TB Expert Committee, and ICMR: Ensuring Reliability and Improved Healthcare Outcomes

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