Savara Introduces aPAP ClearPath™, a GM-CSF Autoantibody Blood Test to Detect Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
December 21 2023 - 8:05AM
Business Wire
- The simple, no-cost, and noninvasive test is now available to
physicians in the U.S.
- Company launches campaign in the U.S. to raise awareness of the
rare autoimmune lung disease and need for early testing
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage
biopharmaceutical company focused on rare respiratory diseases,
recently launched aPAP ClearPath™, a new serum-based blood test
that can be used by physicians in the U.S. to obtain a definitive
diagnosis of aPAP, a rare autoimmune lung disease mediated by
autoantibodies targeting GM-CSF. Autoimmune PAP accounts for
approximately 90% of all patients with PAP and has an estimated
diagnosed prevalence of seven cases per million in the U.S. and
similar or higher prevalence reported elsewhere in the world.
The aPAP ClearPath™ test is a highly sensitive and specific
quantitative immunoassay designed to detect aPAP GM-CSF
autoantibodies in human serum. The Company partnered with Trillium
Health (trillium-health.com), a modern health solutions provider
and a Clinical Laboratory Improvement Amendments (CLIA)-certified
lab, to develop the simple, no-cost, and noninvasive test. A
supporting disease awareness campaign was also launched to improve
understanding of aPAP, highlight the hallmark signs and symptoms of
the disease, and educate physicians about the need for early
testing.
“Our strong operational focus continues as we deliver on our
goal of introducing a laboratory-based GM-CSF autoantibody blood
test in the U.S. by the end of the year,” said Matt Pauls, Chair
and CEO, Savara. “Our commitment to the patient community is
underscored by the introduction of this simple, no-cost blood test
that U.S. physicians can use to confirm or rule out aPAP. With a
few thousand diagnosed patients in the U.S., we suspect the true
prevalence of aPAP may be underestimated and, similar to other rare
diseases, the introduction of a diagnostic could help decrease the
time to diagnosis and increase diagnosed prevalence.”
“Education and widespread blood testing for aPAP is a critical
step in shortening the time to diagnosis for patients with aPAP,
helping to avoid misdiagnoses and more costly and invasive
diagnostic procedures,” said Ali Ataya, M.D., Associate Professor
of Medicine, University of Florida, Division of Pulmonary and
Critical Care Medicine. “I congratulate Savara for making this
simple test broadly available for physicians in the U.S.”
Only a physician or healthcare provider can make a diagnosis of
aPAP. To learn more about aPAP ClearPath™, the importance of early
testing for aPAP, and to order a test kit, please visit
www.apapclearpath.com.
The Company expects to roll out a healthcare provider disease
awareness campaign and GM-CSF autoantibody blood test in Europe
next year.
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. Such statements include, but are not limited to,
statements related to the estimated prevalence of aPAP and the
suspicion it may be underestimated, the potential benefits and
impact of aPAP ClearPath™ and aPAP education, including on the time
to diagnosis and diagnosed prevalence, and the expected timing of
the disease awareness campaign and autoantibody blood test in
Europe. 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 degree to
which aPAP ClearPath™ is accepted and used by healthcare providers,
disruptions or inefficiencies in the supply chain and geopolitical
conditions on our business and operations, 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
Savara (NASDAQ:SVRA)
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