Eidos Therapeutics to Present Interim Analysis of the Ongoing Phase 2 Open-Label Extension Study of AG10 in Patients with TTR...
September 30 2019 - 7:00AM
Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), a clinical stage
biopharmaceutical company focused on addressing the large and
growing unmet need in transthyretin (TTR) amyloidosis (ATTR), today
announced that an interim analysis of its ongoing Phase 2
open-label extension (OLE) study of AG10 in subjects with
symptomatic ATTR cardiomyopathy will be presented in a
late-breaking featured science oral presentation at this year’s
American Heart Association (AHA) Scientific Sessions.
Daniel Judge, M.D., professor in the division of cardiology at
the Medical University of South Carolina, will discuss the data in
a presentation entitled “Long-term Safety and Efficacy of AG10 in
Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM):
Interim Analysis of the Ongoing Phase 2 Open-Label Extension Study”
at 5:30 PM ET on November 16, 2019 as part of the Early Phase
Science oral session.
In addition, Eidos will present several posters at AHA. The
following summarizes Eidos’ presentations at the conference:
- Long-term Safety and Efficacy of AG10 in Patients with
Transthyretin Amyloid Cardiomyopathy (ATTR-CM): Interim Analysis of
the Ongoing Phase 2 Open-Label Extension Study
(Dr. Daniel Judge; Saturday, November 16, Oral Presentation:
5:30-5:38 PM)
- ATTRibute-CM: A Randomized, Double-Blind,
Placebo-Controlled, Multi-Center, Global Phase 3 Study of AG10 in
Patients with Transthyretin Amyloid Cardiomyopathy
(ATTR-CM) (Dr. Daniel Judge; Monday, November
18; Poster Display: 11:30-12:00 PM)
- Differential Transthyretin Binding, Kinetic Stability
and Additive Ex Vivo Stabilization by AG10 Compared to
Tafamidis (Dr. Uma Sinha; Monday, November 18;
Poster Display: 1:30-2:00 PM)
- Differential Ex Vivo Stabilization of Transthyretin by
AG10 and Tafamidis in Samples from Patients with Moderate or
Severely Destabilizing Mutations (Dr. Uma
Sinha; Monday, November 18; Poster Display: 1:30-2:00
PM)
About AG10
AG10 is an investigational, orally-administered small molecule
designed to potently stabilize tetrameric transthyretin, or TTR,
thereby halting at its outset the series of molecular events that
give rise to TTR amyloidosis, or ATTR. In a Phase 2 clinical trial
in patients with symptomatic ATTR-CM, AG10 was generally well
tolerated, demonstrated greater than 90 percent average TTR
stabilization at Day 28, and increased serum TTR concentrations, a
prognostic indicator of survival in a retrospective study of
ATTR-CM patients, in a dose-dependent manner.
AG10 was designed to mimic a naturally-occurring variant of the
TTR gene (T119M) that is considered a rescue mutation because
co-inheritance has been shown to prevent or ameliorate ATTR in
individuals also inheriting a pathogenic, or disease-causing,
mutation in the TTR gene. To our knowledge, AG10 is the only TTR
stabilizer in development that has been observed to mimic the
stabilizing structure of this rescue mutation.
The Phase 3 ATTRibute-CM study of AG10 in patients with ATTR-CM
is underway. Part A of the study will assess the change from
baseline in 6-minute walk distance (6MWD) at 12 months. Part B of
the study will evaluate reduction in all-cause mortality and
frequency of cardiovascular-related hospitalizations at 30 months.
In addition, Eidos plans to initiate a Phase 3 study of AG10 in
ATTR polyneuropathy (ATTR-PN) by the end of 2019.
About transthyretin amyloidosis (ATTR)
There is significant medical need in transthyretin amyloidosis
(ATTR) given the large patient population and limited current
standard of care. ATTR is caused by the destabilization of TTR due
to inherited mutations or aging and is commonly divided into three
distinct categories: wild-type ATTR cardiomyopathy (ATTRwt-CM),
mutant ATTR cardiomyopathy (ATTRm-CM), and ATTR polyneuropathy
(ATTR-PN). The worldwide prevalence of each disease is
approximately 400,000 patients, 40,000 patients and 10,000
patients, respectively.
All three forms of ATTR are progressive and fatal. For patients
with untreated ATTRwt-CM and ATTRm-CM, symptoms usually manifest
later in life (age 50+), with median survival of three to five
years from diagnosis. ATTR-PN either presents in a patient's early
30s or later (age 50+), and results in a median life expectancy of
five to ten years from diagnosis for untreated patients.
Progression of all forms of ATTR causes significant morbidity,
impacts productivity and quality of life, and creates a significant
economic burden due to the costs associated with progressively
greater patient needs for supportive care.
About Eidos Therapeutics
Eidos is a BridgeBio Pharma subsidiary focused on addressing the
large and growing unmet need caused by transthyretin (TTR)
amyloidosis (ATTR). Eidos is developing AG10, a potentially
disease-modifying therapy for the treatment of ATTR. For more
information, please visit www.eidostx.com.
Forward-Looking Statements
This release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act. All statements other than
statements of historical facts, including the statements about the
potential therapeutic and clinical benefits of AG10, the potential
for AG10 to be a safe and effective treatment for all forms of
ATTR-CM, the potential registrational endpoints in the ATTRibute-CM
trial, our ability to enroll patients in and conduct the
ATTRibute-CM trial and our planned Phase 3 clinical trial of AG10
in ATTR-PN in accordance with our plans, the timing of these
events, the indications we intend to pursue and our possible
clinical or other business strategies, are forward-looking
statements. Forward-looking statements can be identified by terms
such as “believes,” “expects,” “plans,” “potential,” “would” or
similar expressions and the negative of those terms. These
forward-looking statements are based on our management’s current
beliefs and assumptions about future events and on information
currently available to management. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
that may cause our actual results, performance or achievements to
be materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. These risks include, but are not limited to, risks and
uncertainties related to: our limited operating history and
historical losses, our liquidity to fund the development of AG10
through current and future milestones, our ability to raise
additional funding to complete the development of AG10, our
dependence on the success of AG10, our ability to enroll patients
in the ATTRibute-CM trial and our planned Phase 3 clinical trial of
AG10 in ATTR-PN, results from our clinical trials
and pre-clinical studies and those of third parties
working in the same area as our product candidate, our ability to
advance AG10 in clinical development in accordance with our plans,
and our dependence on third parties in connection with our
manufacturing, clinical trials and pre-clinical studies.
Additional risks and uncertainties that could affect our future
results are included in the section titled “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” in our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2019, which is available on the SEC’s
website at www.sec.gov and our website at eidostx.com.
Additional information on potential risks will be made available in
other filings that we make from time to time with the SEC. In
addition, any forward-looking statements contained in this press
release are based on assumptions that we believe to be reasonable
as of this date. Except as required by law, we assume no obligation
to update these forward-looking statements, or to update the
reasons if actual results differ materially from those anticipated
in the forward-looking statements.
Media Contact:Carolyn Hawley Canale
Communications619-849-5382Carolyn@canalecomm.com
Investor Contact:John GrimaldiBurns
McClellan212-213-0006jgrimaldi@burnsmc.com
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