The burden of respiratory diseases, from asthma and COPD to pulmonary fibrosis, keeps pressure on the development of more effective and better targeted therapies. A critical step in that process is preclinical evaluation in translational animal models that reflect human disease rather than approximating it. Prisys Biotech works on this problem with an integrated platform of non-human primate (NHP) models, drug delivery systems, and assessment technologies that sponsors use to test respiratory candidates before the clinic.
Precision Pulmonary Drug Delivery: Reaching the Target
Delivering therapeutics directly to the lungs raises local efficacy while limiting systemic exposure. Prisys Biotech has established several administration routes, each supported by dedicated equipment, so that the delivery method can be matched to the modality and the question being asked.
Administration Routes:
- Inhalation via Atomization: A non-invasive and clinically relevant route, well suited to chronic therapies. It delivers aerosolized drugs directly to the airways and deep lung tissue.
- Intrabronchial Administration: A targeted approach that delivers therapeutics locally to the bronchi, raising drug concentration at the site of inflammation or disease.
- Endotracheal Administration: Rapid and direct delivery to the trachea, often using a high-pressure spray needle. This method is used for acute models and for certain therapeutic interventions.
Core Technology: The Aerogen Atomization System
The inhalation work is built around the Aerogen atomization system. Integrated with an animal ventilator, it produces consistent deep lung deposition of aerosolized agents such as lipopolysaccharide (LPS) for acute lung inflammation models, or house dust mite (HDM) and ovalbumin for asthma and allergic airway models. Deposition that varies between animals turns into variability in the disease itself, so particle delivery has to be controlled before any efficacy comparison means much.
Prisys Biotech also offers the Nasal-to-Brain (N2B) delivery system, which uses devices such as the DriDose® for dry powder delivery, extending the range of administration routes available for programs that need to bypass the blood-brain barrier.
Pulmonary Assessment: A Window into Lung Health
Evaluating a drug's effect requires methods that measure physiological change and biological response inside the lungs. Prisys Biotech uses a set of established assessment techniques.
Bronchoalveolar Lavage Fluid (BALF) Analysis
BALF collection samples the lung's cellular and molecular environment. It provides data on:
- Target Engagement: Baseline expression of drug targets, and the knockdown efficiency of nucleic acid therapies.
- Inflammatory Response: Key inflammatory cytokines such as IL-6, IL-8, IL-1β, and TNF-α, quantified by ELISA.
- Cellular Infiltration: Differential cell counts that identify and quantify immune cell infiltration. A clear rise in eosinophils, for example, is a classic hallmark of asthmatic inflammation and is reliably captured in these models.
The procedure is performed on anesthetized, intubated animals, which keeps sample quality high enough for downstream analysis. Because BALF sits close to the drug's site of action, the readouts map naturally onto Pharmacodynamics (PD) endpoints rather than serving only as descriptive pathology.
Pulmonary Function Testing (PFTs)
Direct measurement of lung mechanics is what makes bronchodilator and anti-inflammatory efficacy visible. Prisys Biotech is equipped with large-animal pulmonary function testing systems, bronchoscopes, and physiological monitors for these assessments.
A key test is the Acetylcholine (ACh) Challenge, used to measure airway hyperresponsiveness (AHR), a cardinal feature of asthma. Anesthetized and ventilated animals are exposed to escalating concentrations of ACh, and the resulting increase in lung resistance (RL) is measured. Calculating PC50, the provocative concentration that causes a 50% increase in baseline RL, gives an objective and quantitative measure of how far a drug mitigates AHR.
A Suite of Validated Respiratory Disease Models
These delivery and assessment technologies feed into a portfolio of validated and developing NHP respiratory disease models. By reproducing human pathophysiology, the models give partners a platform for efficacy work that small-animal studies cannot fully provide. Established expertise at Prisys Biotech covers:
- Acute Lung Inflammation / Acute Respiratory Distress Syndrome (ARDS)
- Asthma (Allergic and Non-allergic)
- Chronic Obstructive Pulmonary Disease (COPD)
- Pulmonary Embolism
- Pulmonary Arterial Hypertension (PAH)
- Pulmonary Fibrosis
- Allergic Rhinitis
Acute lung inflammation, asthma and fibrosis differ in time course as much as in mechanism, and the readouts differ with them. An LPS-driven acute model is usually scored over hours to days on BALF cytokines and cellular influx, while a fibrosis model is followed over weeks on imaging and histology. Matching the model to the stage of the program is part of the design work, since a readout that suits one question often says little about another.
Integrating Delivery, Readout And Model Choice
Success in respiratory drug development depends on predictive preclinical models and on measurement techniques that resolve the effect being claimed. Prisys Biotech combines NHP models with pulmonary drug delivery and functional and biomarker analyses, so that mechanism of action, efficacy and exposure can be examined in one study rather than in disconnected batches of data.
Programs usually arrive with one of three questions: whether the compound reaches the lung compartment, whether it changes lung function, or whether it alters the inflammatory picture. The platform is organized so that all three can be answered for the same animal where the design allows it.
To discuss a respiratory program, contact us and describe the model, route and endpoints you have in mind.
