Eidos Therapeutics Presents Data from its Phase 1 Clinical Trial of AG10 at the 22nd Annual Scientific Meeting of the Heart F...
September 17 2018 - 8:00AM
Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX) announced the
presentation of results from its Phase 1 clinical trial of AG10
during a poster session at the 22nd Annual Scientific Meeting of
the Heart Failure Society of America (HFSA). The poster, entitled
“AG10, A Novel, Potent, and Selective Transthyretin Stabilizer, Is
Well-Tolerated at Doses Resulting in Target Therapeutic Blood
Levels, and Demonstrates Clinical Proof-of-Concept in Healthy
Volunteers,” was presented on Saturday, September 15, and is
accessible through the science section of the company’s website.
In this initial Phase 1 study in healthy adult volunteers, AG10
was well-tolerated with no safety signals of potential clinical
concern identified. At the highest tested dose, AG10 achieved 100%
transthyretin (TTR) stabilization at peak concentration and over
95% TTR stabilization on average at steady state. Serum TTR
concentrations, an in vivo indicator of TTR stability, were
increased to a greater degree in AG10-treated patients than
placebo-treated patients from baseline to Day 12.
“We believe that maximizing the level of TTR stabilization will
lead to optimal clinical benefit for TTR Amyloidosis (ATTR)
patients. This initial human trial demonstrated that AG10
stabilized TTR in established ex vivo assays and increased
circulating TTR concentrations,” noted Jonathan C. Fox, M.D.,
Ph.D., president and chief medical officer of Eidos. “Given that
below normal levels of serum TTR are associated with poorer
prognosis in ATTR patients, and stabilization of TTR by protective
mutations or small molecule stabilizers increase serum TTR
concentrations, we believe that these data provide clinical proof
of concept. We are rapidly moving forward with additional studies
of AG10 and have already completed enrollment in our Phase 2 trial
in patients with symptomatic ATTR cardiomyopathy (ATTR-CM).”
TTR normally circulates in the blood as a four-part molecule, or
tetramer. In ATTR, the tetramer is destabilized by inherited
mutation or age-related factors and dissociates into individual
monomers, which can aggregate and are deposited as amyloid fibrils
in various tissues. AG10, Eidos’ lead product candidate, is
designed to target ATTR at its source by stabilizing tetrameric TTR
in the blood. Eidos is pursuing AG10 for the treatment of ATTR-CM
and ATTR polyneuropathy (ATTR-PN), both of which are progressive,
fatal diseases. The company plans to initiate Phase 3 studies in
each indication in the first half of 2019.
About AG10
AG10 is an 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 transthyretin amyloidosis, or ATTR. AG10 is currently being
tested in a Phase 2 clinical trial in patients with symptomatic
ATTR cardiomyopathy. Top-line results from this trial are expected
to be reported in the fourth quarter of 2018.
AG10 was designed to mimic a naturally-occurring variant of the
TTR gene (T119M) that is considered a “rescue mutation” because it
has been shown to prevent ATTR in individuals carrying pathogenic,
or disease-causing, mutations in the TTR gene. To our knowledge,
AG10 is the only TTR stabilizer in development that has been
observed to mimic the “super-stabilizing” properties of this rescue
mutation.
About Eidos Therapeutics
Eidos Therapeutics is a clinical stage biopharmaceutical company
focused on addressing the large and growing unmet need in diseases
caused by transthyretin (TTR) amyloidosis (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
future clinical milestones of AG10, including the completion of our
ongoing Phase 2 clinical trial and availability of top-line data
therefrom, the initiation of Phase 3 clinical trials, 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 our other product candidates through current and
future milestones, our ability to raise additional funding to
complete the development and any commercialization of our product
candidates, our dependence on the success of our lead product
candidate, AG10, results from our clinical trials
and pre-clinical studies and those of third parties
working in the same area as our product candidate 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 the final prospectus for our initial public offering
filed with the SEC on June 21, 2018, and our Quarterly Report
on Form 10-Q for the quarter ended June 30, 2018, which are
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 Communications, (619) 849-5382,
carolyn@canalecomm.com
For Investors
Alex Gray, Burns McClellan, (212) 213-0006,
agray@burnsmc.com
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