Attralus Receives Breakthrough Therapy Designation for its Pan-Amyloid Diagnostic PET Imaging Candidate 124I-evuzamitide (AT-01) for Cardiac Amyloidosis
05 Agosto 2024 - 6:00AM
Attralus, Inc., a clinical stage biopharmaceutical company
developing transformative products to improve the lives of patients
with systemic amyloidosis, today announced that its investigational
diagnostic imaging agent drug, 124I-evuzamitide (AT-01), has been
granted Breakthrough Therapy Designation (BTD) by the U.S.
Food and Drug Administration (FDA) for positron emission
tomography (PET) imaging in patients with suspected or known
cardiac amyloidosis. FDA granted BTD for 124I-evuzamitide (AT-01)
based on clinical data from Attralus-sponsored and
investigator-initiated studies evaluating the use of
124I-evuzamitide in patients with cardiac amyloidosis, representing
experience in more than 200 trial participants.
BTD is a program used by the FDA to expedite the development and
review of a product when: (1) intended to treat or diagnose a
serious or a life-threatening condition; and (2) when preliminary
clinical evidence indicates that the drug may demonstrate
substantial improvement over available therapies on one or more
clinically significant endpoints. BTD products are eligible for
more intensive guidance from FDA to expedite development, including
an organizational commitment by FDA and eligibility for Biologics
License Application (BLA) rolling and priority review.
“We are highly encouraged by FDA’s decision to grant
Breakthrough Therapy Designation to 124I-evuzamitide (AT-01),
recognizing its potential as an innovative diagnostic agent for
patients with systemic amyloidosis” said Gregory Bell, M.D., Chief
Medical Officer, Attralus. “There are no FDA approved diagnostic
imaging agents for cardiac amyloidosis. The diagnosis of cardiac
amyloidosis is a challenging and time-consuming process for
patients, with many going years without an accurate diagnosis, and
losing critical time in the process. We remain committed to
bringing 124I-evuzamitide to the market as quickly as possible and
look forward to working more closely with FDA to bring
124I-evuzamitide to patients.”
About Systemic Amyloidosis Systemic
amyloidosis encompasses a diverse group of rare diseases that occur
due to accumulation of toxic amyloid deposits in tissues and
organs, a consequence of aberrant protein misfolding events. These
diseases are progressive, debilitating and often fatal. The
majority of systemic amyloidosis patients have cardiac involvement,
including the two most common forms, with ~95% of ATTR and 75% of
AL patients having cardiac involvement. Other rare types of
systemic amyloidosis such as AA, AApoAI, AApoAIV also have cardiac
involvement. Cardiac amyloidosis is significantly underdiagnosed
due to low awareness, non- specific symptoms, and lack of
disease-specific diagnostics. There remains a significant unmet
need for better diagnostics that may be able to more accurately
diagnose patients earlier in the disease process.
About
124I-evuzamitide (AT-01) Pan-Amyloid
Diagnostic124I-evuzamitide (AT-01) is the first
non-invasive pan-amyloid PET imaging agent specifically designed
for systemic amyloidosis. 124I-evuzamitide utilizes the company’s
pan-amyloid binding peptide labeled with iodine-124 as an
amyloid-specific imaging agent to image all types of systemic
amyloidosis by PET/CT imaging. In clinical trials, 124I-evuzamitide
has been shown to detect multiple types of amyloid deposits,
including ATTR and AL, in major organs such as the heart, kidney,
liver, and spleen. Orphan drug designations have been granted to
124I-evuzamitide as a diagnostic for the management of ATTR and AL
amyloidosis by both the Food and Drug Administration (FDA) and the
European Commission.
About Attralus Attralus
is a clinical stage biopharmaceutical company focused on creating
transformative products to improve the lives of patients with
systemic amyloidosis. The company’s proprietary pan-amyloid removal
(PAR) therapeutics are designed to directly bind to and remove
toxic amyloid in organs and tissues. By targeting the
disease-causing pathology in systemic amyloidosis diseases, PAR
therapeutics have the potential to treat and reverse disease in
patients with all types and stages of systemic amyloidosis.
Attralus was founded by scientific experts in the field of
amyloidosis and the company is headquartered in Burlingame, CA.
Forward-Looking Statements This press
release contains forward-looking statements, including statements
related to the efficacy, continued development, and potential of
AT-01. Words such as “developing,” “potential,” “shown” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Attralus’ current
expectations. Forward-looking statements involve risks and
uncertainties. Attralus’ actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties. Attralus expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in Attralus’ expectations with regard thereto or any change in
events, conditions, or circumstances on which any such statements
are based.
Contact:Krishna Gorti, M.D. FRCSCorporate
Developmentkgorti@attralus.com