Breakthrough Clinical Results
IMVARIA Inc. announced the presentation of multi-site clinical experience results with its FDA-authorized AI diagnostic service, Fibresolve, at the ATS 2025 International Conference. Fibresolve assists in the assessment of suspected Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF). The data showcases real-world use of Fibresolve by pulmonologists across the U.S. IMVARIA also presented data on its other AI solutions, ScreenDx (FDA-cleared) and the investigational Bronchosolve. Fibresolve is the first FDA-authorized AI adjunctive diagnostic service for lung fibrosis and has adopted CPT billing codes.
Key Highlights
- Presentation of multi-site clinical experience data on Fibresolve at ATS 2025.
- Fibresolve is the first FDA-authorized AI adjunctive diagnostic service for lung fibrosis.
- Data showcases real-world use of Fibresolve by pulmonologists in the U.S.
- IMVARIA also presented data on ScreenDx and the investigational Bronchosolve.
Incidence and Prevalence
Idiopathic Pulmonary Fibrosis (IPF) is a chronic, progressive, and ultimately fatal lung disease. Pinpointing exact global incidence and prevalence is challenging due to variations in study methodologies, diagnostic criteria, and data collection methods across different countries and regions. However, several studies provide estimates, and trends suggest a rising global burden of IPF.
Incidence:
- A 2024 meta-analysis estimated that 21% of IPF cases could be attributed to occupational exposures, with a pooled odds ratio of 1.8. This study also found that 44% of patients with IPF reported occupational exposure to vapors, gas, dust, and fumes.
- A 2021 study found adjusted incidence estimates ranging from 0.35 to 1.30 per 10,000 population in Asia-Pacific countries, 0.09 to 0.49 in Europe, and 0.75 to 0.93 in North America. South Korea had the highest reported incidence.
- A 2018 study in England reported an increase in incidence over time, with the best estimate ranging from 8,000 to 9,000 new cases per year.
- A 2015 study estimated a conservative incidence range of 3-9 cases per 100,000 per year for Europe and North America, with lower rates in East Asia and South America.
- Studies from the early 2010s reported incidence rates ranging from 6.8-8.8 per 100,000 in the US (using narrow case definitions) and 0.22 to 7.4 per 100,000 in Europe. These older studies likely underestimate the true incidence due to limitations in diagnostic capabilities and awareness.
Prevalence:
- A 2021 study found adjusted prevalence estimates ranging from 0.57 to 4.51 per 10,000 population in Asia-Pacific countries, 0.33 to 2.51 in Europe, and 2.40 to 2.98 in North America. South Korea had the highest reported prevalence.
- A 2018 study in England estimated that IPF prevalence was higher than previously reported.
- A 2015 study found that the incidence of IPF is increasing worldwide, with rates converging across countries.
- A 2014 study in Taiwan found that IPF prevalence more than doubled between 2000 and 2007, rising from 2.8 to 6.4 cases per 100,000 persons (broad definition) and from 2.0 to 4.9 cases per 100,000 persons (narrow definition).
- Studies from the early 2010s reported prevalence estimates in the US varying between 14 and 27.9 cases per 100,000 population (narrow case definitions) and 42.7 and 63 per 100,000 population (broad case definitions). In Europe, prevalence ranged from 1.25 to 23.4 cases per 100,000 population.
Overall:
While older studies suggest IPF is a rare disease, more recent data indicate a rising incidence and prevalence globally, possibly due to increased awareness, improved diagnostics, and an aging population. There's a clear need for standardized methodologies and ongoing epidemiological research to better characterize the true global burden of IPF. It's important to note that IPF prevalence and incidence increase with age and are generally higher among males.
Unmet Needs and Target Populations in Idiopathic Pulmonary Fibrosis (IPF) Research (Based on PubMed Publications from 2021-2024):
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and ultimately fatal lung disease characterized by scarring and stiffening of the lung tissue. Despite the approval of two antifibrotic drugs, pirfenidone and nintedanib, which can slow disease progression, there remains a significant unmet need for more effective therapies and improved understanding of the disease. Recent research, as reflected in PubMed publications from the past three years (2021-2024), has highlighted several key unmet needs and target populations in IPF:
1. Early Diagnosis and Prediction of Disease Progression:
- Need: Earlier diagnosis of IPF is crucial for timely intervention and improved patient outcomes. Current diagnostic methods often involve a lengthy process of exclusion and can delay treatment initiation. There is also a need for better prediction tools to identify individuals at high risk of rapid disease progression or acute exacerbations.
- Target Population: Individuals with early or preclinical IPF, those with suspected IPF, and patients with established IPF at risk of rapid decline.
- Research Focus: Development of non-invasive diagnostic biomarkers, improved imaging techniques, and prognostic models incorporating clinical, genetic, and molecular data.
2. Addressing the Heterogeneity of IPF:
- Need: IPF is a heterogeneous disease, with patients experiencing varying disease trajectories and responses to treatment. This heterogeneity makes it challenging to develop and evaluate new therapies.
- Target Population: Identifying distinct IPF subtypes based on clinical, genetic, or molecular characteristics.
- Research Focus: Investigating the underlying mechanisms driving different IPF phenotypes, developing personalized treatment strategies, and identifying biomarkers that predict treatment response.
3. Targeting Specific Pathogenic Pathways:
- Need: While antifibrotic therapies can slow disease progression, they do not address the underlying causes of IPF. There is a need for therapies that target specific pathogenic pathways involved in fibrosis, inflammation, and epithelial cell dysfunction.
- Target Population: Patients with progressive IPF, those with specific genetic or molecular profiles, and individuals with acute exacerbations.
- Research Focus: Development of novel therapies targeting pathways such as TGF-β, LPA, integrins, and other key mediators of fibrosis. Investigating the role of cellular senescence, telomere dysfunction, and other age-related processes in IPF pathogenesis.
4. Improving Symptom Management and Quality of Life:
- Need: IPF is associated with debilitating symptoms such as cough, dyspnea, and fatigue, which significantly impact patients' quality of life. Current therapies often provide limited relief from these symptoms.
- Target Population: Patients with symptomatic IPF, those experiencing significant functional limitations, and individuals with advanced disease.
- Research Focus: Development of effective therapies for cough, dyspnea, and fatigue in IPF. Investigating the role of non-pharmacological interventions such as pulmonary rehabilitation and palliative care in improving quality of life.
5. Addressing Comorbidities:
- Need: IPF patients often have other medical conditions (comorbidities) that can complicate disease management and contribute to worse outcomes. There is a need for better strategies to manage these comorbidities and their impact on IPF.
- Target Population: IPF patients with comorbidities such as pulmonary hypertension, gastroesophageal reflux disease, coronary artery disease, and lung cancer.
- Research Focus: Investigating the interplay between IPF and comorbidities, developing integrated care pathways, and optimizing treatment strategies for patients with multiple conditions.
6. Enhancing Patient and Caregiver Support:
- Need: IPF has a profound impact on patients and their caregivers, both physically and emotionally. There is a need for better support services, educational resources, and psychosocial interventions to help patients and caregivers cope with the challenges of living with IPF.
- Target Population: IPF patients, their families, and caregivers.
- Research Focus: Evaluating the effectiveness of different support programs, developing patient-centered educational materials, and investigating the role of psychological interventions in improving patient and caregiver well-being.
In summary, recent research in IPF has identified several key unmet needs and target populations. Addressing these needs through continued research and development of new therapies and diagnostic tools is essential for improving the lives of individuals affected by this devastating disease.
Drug used in other indications
Fibresolve, a machine learning system, is primarily designed and validated for use as an adjunct to non-invasive diagnosis of Idiopathic Pulmonary Fibrosis (IPF). While it has shown promise in predicting mortality in Interstitial Lung Diseases (ILDs), including IPF and non-IPF ILDs, there is no explicit mention in the provided text of it being trialled for other specific indications beyond ILDs.
The studies mentioned focus on its use in classifying IPF, particularly in cases with non-definite Usual Interstitial Pneumonia (UIP) patterns on HRCT scans, and in predicting mortality across ILD subtypes. The provided abstracts detail studies assessing Fibresolve's performance in:
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Classifying IPF:
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In patients with non-definite UIP patterns, Fibresolve demonstrated a sensitivity of 76.5% (95% CI 66.5-83.7) for IPF classification. In a subgroup requiring surgical biopsy, sensitivity was 74.5% (60.5-84.7).
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Fibresolve was able to classify IPF cases even without radiological UIP or probable UIP patterns, with estimated sensitivity of 56-65% and specificity of 92-94%.
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Predicting mortality in ILD:
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Fibresolve scores, categorized by tertile, were significantly associated with mortality in ILD (Tertile 2 HR 1.47, p=0.11; Tertile 3 HR 3.12, p<0.001) after adjusting for tobacco use and modified GAP score.
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Significant associations were found in non-IPF ILDs (Tertile 2 HR 1.95; Tertile 3 HR 4.66) and severe disease (FVC ≤75%) subgroups (Tertile 2 HR 2.29; Tertile 3 HR 4.80).
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In another study, Fibresolve independently predicted mortality risk (HR: 7.14, p=0.02) after adjusting for GAP score and other risk factors. When split into tertiles and adjusted for GAP stages, it also significantly predicted mortality (p=0.027 for the model; HR 1.37 for 2nd tertile; HR 2.19 for 3rd tertile).
The studies primarily employ retrospective analyses of existing patient data from prospective clinical trials, applying Fibresolve to chest CT scans. No intervention models, in the traditional sense of administering a treatment, are described for Fibresolve itself, as it is a diagnostic and prognostic tool. The interventions studied relate to the underlying ILD treatments, such as pirfenidone and nintedanib, while Fibresolve is used to assess their impact or predict outcomes.