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Accelerating Acute Lung Injury Drug Development

Acute lung injury (ALI) presents a significant therapeutic challenge, characterized by rapid-onset respiratory failure and high morbidity. Protheragen is a specialized partner in the development of novel therapeutics targeting ALI, offering integrated preclinical solutions that span target validation, lead optimization, pharmacology, toxicology, and IND-enabling studies. Leveraging deep scientific expertise and advanced technology platforms, Protheragen delivers robust data packages that support the progression of promising candidates through the drug development pipeline. Our multidisciplinary team ensures that every stage of preclinical research meets the highest standards of scientific rigor and regulatory compliance, facilitating a seamless transition to clinical development. With a proven track record in respiratory disease research and a commitment to innovation, Protheragen accelerates the discovery and advancement of effective therapies for acute lung injury, empowering partners to address urgent unmet medical needs.

What is Acute Lung InjuryTargets for Acute Lung InjuryDrug Discovery and Development ServicesWhy Choose Us

What is Acute Lung Injury

Acute Lung Injury (ALI) is a severe, rapidly developing syndrome marked by acute hypoxemia, non-cardiogenic pulmonary edema, and widespread inflammation within the lungs. The condition arises from direct insults to lung tissue, such as pneumonia or aspiration, or indirect systemic causes like sepsis, trauma, or pancreatitis. Pathophysiologically, ALI involves disruption of the alveolar-capillary barrier, leading to increased vascular permeability and accumulation of protein-rich fluid in the alveoli. This process is driven by an exaggerated inflammatory response, with neutrophil activation and release of pro-inflammatory cytokines contributing to endothelial and epithelial cell injury, compromised gas exchange, and reduced lung compliance. Clinically, ALI presents with acute respiratory distress, hypoxemia, and bilateral infiltrates on chest imaging that cannot be attributed to cardiac failure or fluid overload. Diagnosis relies on a combination of clinical assessment, radiological findings, and laboratory criteria, notably a reduced PaO2/FiO2 ratio below 300 mmHg. Early identification and exclusion of alternative causes are essential for management. Treatment is primarily supportive, focusing on optimizing oxygenation and ventilation, while addressing the underlying cause. Pharmacologic options include sivelestat sodium hydrate, which targets the inflammatory cascade to mitigate lung damage and improve respiratory outcomes. Despite advances, ALI remains associated with significant morbidity and mortality.

Launched Drugs

Structure Generic Name CAS Registry Number Molecular Formula Molecular Weight
img-201677-61-4-sivelestat-sodium-hydrate-prop-innm-usan sivelestat sodium hydrate (Prop INNM; USAN) 201677-61-4 C20 H21 N2 O7 S . Na . 4 H2 O 528.506

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Targets for Acute Lung Injury

Targets in Clinical or Later Phases of Development

Target Name Gene Symbol
elastase, neutrophil expressed ELANE
3-hydroxy-3-methylglutaryl-CoA reductase HMGCR
nitric oxide synthase 2 NOS2
coagulation factor III, tissue factor F3
Trypsin (nonspecified subtype)
Serine protease (nonspecified subtype)
BCR activator of RhoGEF and GTPase BCR
colony stimulating factor 1 receptor CSF1R
mitogen-activated protein kinase kinase kinase 2 MAP3K2
mitogen-activated protein kinase kinase kinase 3 MAP3K3

Acute lung injury (ALI) is driven by a complex interplay of inflammatory, immune, and coagulation pathways, with several molecular targets playing pivotal roles in disease progression. Key targets include neutrophil-derived proteases such as elastase (ELANE) and myeloperoxidase (MPO), which mediate tissue damage by degrading extracellular matrix components and generating reactive oxygen species. The colony stimulating factor 1 receptor (CSF1R) regulates monocyte and macrophage activation, further amplifying inflammation. Pro-inflammatory cytokine signaling is orchestrated by the Janus kinase (JAK) family—JAK1, JAK2, and JAK3—which transduce signals from cytokines like IL-6 and IFN-γ, promoting leukocyte recruitment and endothelial dysfunction. Additionally, coagulation factor III (F3) initiates the extrinsic coagulation cascade, leading to microthrombi formation and impaired gas exchange, while inducible nitric oxide synthase (NOS2) contributes to nitrosative stress and vascular permeability. Therapeutically, these targets offer multiple intervention points for mitigating lung injury. ELANE and MPO inhibitors, such as sivelestat and experimental MPO antagonists, aim to reduce protease-mediated and oxidative tissue damage. JAK inhibitors (e.g., baricitinib) are being evaluated in clinical trials for their ability to dampen cytokine-driven inflammation. CSF1R antagonists are explored for immunomodulation, and F3 inhibitors are considered to address coagulopathy. NOS2 inhibition has shown promise in preclinical studies for reducing nitrosative injury. While several of these approaches are in early clinical or preclinical stages, they collectively represent promising strategies for targeted therapy in ALI, aiming to limit injury, improve outcomes, and guide biomarker-driven treatment.

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Drug Discovery and Development Services

In Vitro Efficacy Testing ServicesIn Vivo Model DevelopmentPK/PD Study ServicesIn Vivo Toxicity Assessment ServicesBiomarker Analysis Services
In Vitro Efficacy Testing Services

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Our In Vitro Efficacy Testing Service accelerates Acute Lung Injury (ALI) drug discovery by offering robust biochemical and cell-based assays targeting key ALI pathways. We evaluate drug candidates against critical proteins such as neutrophil elastase, Janus kinases, myeloperoxidase, and nitric oxide synthase 2. Utilizing advanced methodologies including luminescent, fluorescent, FRET, and substrate-specific enzymatic assays, we deliver precise quantification of potency, efficacy, and selectivity. Key pharmacological parameters such as IC-50, pKi, MEC, and MIC guide lead optimization. Our comprehensive, sensitive platforms enable informed therapeutic development and prioritization of promising ALI drug candidates.

Abl Proto-Oncogene 1, Non-Receptor Tyrosine Kinase Elastase, Neutrophil Expressed
Janus Kinase 1 Janus Kinase 2
Janus Kinase 3 Myeloperoxidase
Nitric Oxide Synthase 2

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Why Choose Us

Choosing Protheragen for your Acute lung injury drug development needs means partnering with a team that possesses deep expertise and a proven track record in this challenging therapeutic area. At Protheragen, we have assembled a group of dedicated professionals with extensive experience in Acute lung injury research, ensuring that every project benefits from the latest scientific insights and a thorough understanding of disease mechanisms. Our advanced technology platforms enable us to deliver innovative and efficient solutions throughout the preclinical development process, from target validation to lead optimization and beyond. Protheragen’s history of reliability is built on years of successful collaborations and the consistent delivery of high-quality preclinical services. We adhere to the highest quality standards and maintain rigorous compliance with all relevant regulatory requirements, providing our clients with confidence and peace of mind. Above all, Protheragen is committed to advancing the field of Acute lung injury therapeutics, working tirelessly to translate scientific discoveries into new treatment options that can make a real difference in patients’ lives.

FAQs for Our Services

Q: What are the main preclinical research challenges specific to developing drugs for Acute Lung Injury (ALI)?

A: Preclinical research for ALI faces several unique challenges, including the need for robust and predictive animal models that accurately recapitulate the complex pathophysiology of human ALI. Variability in disease induction methods, such as LPS or ventilator-induced lung injury, can impact data reproducibility and translational relevance. Additionally, assessing endpoints like lung edema, inflammation, and gas exchange requires specialized expertise and equipment. Our company addresses these challenges by employing validated animal models, standardized protocols, and advanced imaging and biomarker analysis to ensure high-quality, translatable data.

Q: What regulatory considerations should be taken into account during preclinical development of ALI therapeutics?

A: Regulatory agencies such as the FDA and EMA require comprehensive preclinical data to support the safety and efficacy of new ALI therapeutics. This includes pharmacokinetics, pharmacodynamics, toxicology, and proof-of-concept efficacy studies in relevant models. For ALI, demonstrating both short-term and long-term effects, as well as safety in the context of lung injury, is critical. Our team is experienced in designing studies that meet regulatory expectations, including GLP-compliant toxicology and efficacy studies, and can assist with preparing regulatory submissions and addressing agency feedback.

Q: What technical aspects are important to consider in preclinical ALI research?

A: Technical aspects crucial to ALI research include the selection of appropriate animal models (e.g., mice, rats, or larger mammals), induction methods (chemical, mechanical, or infectious), and the use of advanced endpoints such as lung histopathology, bronchoalveolar lavage analysis, and pulmonary function testing. Accurate dosing and administration routes, as well as the timing of therapeutic intervention relative to lung injury induction, are also essential for meaningful results. Our facilities are equipped with state-of-the-art instrumentation and staffed by experienced scientists to ensure technical excellence throughout the study.

Q: What are the typical timeline and cost considerations for preclinical development of ALI drugs?

A: The preclinical phase for ALI drug development typically spans 12 to 24 months, depending on the complexity of the program and regulatory requirements. Costs can vary widely based on the number and type of studies required, with comprehensive efficacy and safety packages often ranging from several hundred thousand to over a million USD. Our company offers tailored project management and budgeting services to optimize timelines and costs, leveraging our expertise and infrastructure to deliver high-quality data efficiently.

Q: What are the key success factors in preclinical drug development for Acute Lung Injury?

A: Key success factors include selecting predictive and validated animal models, employing robust study designs, and utilizing clinically relevant endpoints. Early and ongoing engagement with regulatory agencies, as well as interdisciplinary collaboration among pharmacologists, toxicologists, and clinicians, are also critical. Our company’s integrated approach, combining scientific rigor, regulatory insight, and technical expertise, maximizes the likelihood of successful translation from preclinical research to clinical development for ALI therapeutics.

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