Savara Presented New Data on Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2024
Savara (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented significant data at the American Thoracic Society (ATS) 2024 International Conference. The event, taking place from May 17-22, 2024, in San Diego, CA, featured two important posters.
Poster Board 701, sponsored by Savara, detailed a cohort study revealing that pulmonary alveolar proteinosis (PAP) patients face a substantial healthcare burden. This includes a 4-fold increase in hospital admissions and costs compared to non-PAP controls.
Poster Board 702, presented by Trillium Health , showcased a novel laboratory test for diagnosing autoimmune pulmonary alveolar proteinosis (aPAP) with 100% clinical accuracy. This test detects GM-CSF antibodies in human serum, offering a precise and sensitive diagnostic tool.
- Savara presented data on the high healthcare burden of PAP, highlighting the significant unmet need in this patient population.
- The novel laboratory test for diagnosing aPAP, developed by Trillium Health , showed 100% clinical accuracy.
- The data presented at a reputable conference (ATS 2024) enhances Savara's visibility and credibility in the medical community.
- The reported high healthcare burden of PAP could imply increased costs and resource allocation for treatment, impacting long-term financial sustainability.
- The novel test for aPAP diagnosis, while accurate, still needs broader validation and regulatory approval, posing potential future hurdles.
Savara’s Partner, Trillium Health LLC, Presented Data on the Laboratory Blood Test for Diagnosing aPAP
Below are summaries of the posters presented:
Poster Board 701: “Healthcare Burden of Pulmonary Alveolar Proteinosis” presented by E. Lee, M.D., Ph.D.; sponsored by Savara Inc.
- Presented data from a retrospective cohort analysis using a longitudinal claims database (IPM.ai) comparing the clinical and economic burden of a sample of 2,312 pulmonary alveolar proteinosis (PAP) patients to 9,247 non-PAP matched controls.
- Data demonstrated PAP patients experience higher healthcare resource utilization and higher pharmaceutical and non-pharmaceutical costs as evidenced by a 4-fold increase in hospital admissions, 6-fold increase in in-patient visits, and a 4-fold increase in cost of care, as well as higher rates of comorbidities, procedures, and therapy use (all parameters p<0.001), thereby highlighting a significant unmet need in this rare disease patient population.
- Click here to view the abstract.
- Lee E, Ataya A, McCarthy C, Cosenza J, Bielecki S, Wang TS. Healthcare burden of pulmonary alveolar proteinosis. Am J Respir Crit Care Med 2024;209:A1173.
Poster Board 702: “Development of a Novel Laboratory Test for the Detection of GM-CSF Antibodies to Aid in the Diagnosis of Individuals At-risk for Autoimmune Pulmonary Alveolar Proteinosis (aPAP)” presented by A. Ali and J. Kim of Trillium Health LLC
- Presented data on the development and performance characteristics of a novel laboratory test for the detection of granulocyte-macrophage colony-stimulating factor (GM-CSF) antibodies in human serum to aid in the diagnosis of aPAP.
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Clinical accuracy of
100% was achieved in a cohort of 40 subjects (negative cohort n=20, positive cohort n=20), demonstrating Trillium’s particle-based flow cytometry immunoassay test offers a highly precise and sensitive laboratory test for the determination of GM-CSF antibody levels in human serum and, thus, can successfully be used as a tool to definitively diagnose aPAP. - Click here to view the abstract.
- Kim J, Cornish D, Ali A. Development of a novel laboratory test for the detection of GM-CSF antibodies to aid in the diagnosis of individuals at-risk for autoimmune pulmonary alveolar proteinosis (aPAP). Am J Respir Crit Care Med 2024;209:A1174.
The full content of these posters is available in the Articles and Publications page of the Savara corporate website. Additionally, the abstracts are published in a supplement of the American Journal of Respiratory and Critical Care Medicine (AJRCCM). For more details about the ATS International Conference please visit https://conference.thoracic.org/index.php.
About aPAP
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant sediment in the alveoli (or air sacs) of the lungs. The surfactant consists of proteins and lipids and is an important physiological substance that lines the inside of the alveoli to prevent the lungs from collapsing. In a healthy lung, the old and inactivated surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering the macrophages unable to perform their tasks. As a result, an excess of surfactant accumulates in the alveoli, causing obstruction of gas exchange, and patients start to experience shortness of breath, often with cough and frequent fatigue. Patients may also experience chronic cough, as well as episodes of fever, chest pain, or coughing blood, especially if secondary lung infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH). Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com. (X, formerly known as Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the outcome of our ongoing and planned clinical trials for our product candidate, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs, the ability to successfully develop our product candidate, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as molgramostim that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
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Savara Inc. IR & PR
Anne Erickson (anne.erickson@savarapharma.com)
(512) 851-1366
Source: Savara Inc.
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