Mineralys Therapeutics Selected for Oral Poster Presentation of Target-HTN Phase 2 Trial Results at 2023 AHA Hypertension Scientific Sessions
05 Settembre 2023 - 10:05PM
Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage
biopharmaceutical company focused on developing medicines to target
hypertension, chronic kidney disease and other diseases driven by
abnormally elevated aldosterone, today announced it has been
selected to present the full results from the Target-HTN Phase 2
trial of lorundrostat in individuals with uncontrolled hypertension
(uHTN) or resistant hypertension (rHTN) in an oral poster
presentation at the 2023 American Heart Association (AHA)
Hypertension Scientific Sessions, which is being held in Boston
from September 7–10.
Oral Poster Presentation
Details: |
Poster Title: |
Aldosterone Synthase Inhibition with Lorundrostat for the Treatment
of Uncontrolled Hypertension: The Target-HTN Randomized Clinical
Trial |
Presenter Name: |
Luke Laffin, M.D., cardiologist,
Cleveland Clinic's Heart, Vascular & Thoracic Institute, and
lead investigator of the Target-HTN trial |
Presentation Number: |
113 |
Date/Time: |
Sunday, September 10 at 7:45 a.m.
ET |
Session Title: |
19.C Insight from the Late
Breaking Clinical Trials |
|
|
About HypertensionHaving
sustained, elevated blood pressure (or hypertension) increases the
risk of heart disease, heart attack and stroke, which are leading
causes of death in the U.S. In 2020, more than 670,000 deaths in
the U.S. included hypertension as a primary or contributing cause.
Hypertension and related health issues resulted in an average
annual economic burden of about $130 billion each year in the U.S.,
averaged over 12 years from 2003 to 2014.
Less than 50 percent of hypertension patients
achieve their blood pressure goal with currently available
medications. Abnormally elevated aldosterone levels are a key
factor in driving hypertension in approximately 25 percent of all
hypertensive patients.
About LorundrostatLorundrostat is
a proprietary, orally administered, highly selective aldosterone
synthase inhibitor being developed for the treatment of
uncontrolled hypertension and CKD. Lorundrostat was designed to
reduce aldosterone levels by inhibiting CYP11B2, the enzyme
responsible for its production. Lorundrostat has 374-fold
selectivity for aldosterone-synthase inhibition versus
cortisol-synthase inhibition in vitro, an observed half-life of
10-12 hours and demonstrated approximately a 70% reduction in
plasma aldosterone concentration in hypertensive subjects.
About Mineralys
TherapeuticsMineralys Therapeutics is a clinical-stage
biopharmaceutical company focused on developing medicines to target
hypertension, chronic kidney disease and other diseases driven by
abnormally elevated aldosterone. Its initial product candidate,
lorundrostat, is a proprietary, orally administered, highly
selective aldosterone synthase inhibitor that Mineralys
Therapeutics is developing for cardiorenal conditions affected by
abnormally elevated aldosterone, including hypertension and CKD.
Mineralys is based in Radnor, Pennsylvania, and was founded by
Catalys Pacific. For more information, please visit
https://mineralystx.com. Follow Mineralys on LinkedIn and
Twitter.
Forward-Looking
StatementsMineralys Therapeutics cautions you that
statements contained in this press release regarding matters that
are not historical facts are forward-looking statements. The
forward-looking statements are based on our current beliefs and
expectations and include, but are not limited to, statements
regarding: the potential therapeutic benefits of lorundrostat; the
Company’s expectation that aldosterone synthase inhibitors (ASIs)
with an SGLT2 inhibitor may provide additive clinical benefits to
patients; the Company’s expectation that the Advance-HTN and the
planned Phase 3 clinical trial of lorundrostat may serve as pivotal
trials in any submission of a new drug application (NDA) to the
United States Food and Drug Administration (FDA); the Company’s
ability to evaluate lorundrostat as a potential treatment for CKD;
the planned future clinical development of lorundrostat and the
timing thereof; and the expected timing of commencement and
enrollment of patients in clinical trials and topline results from
clinical trials. Actual results may differ from those set forth in
this press release due to the risks and uncertainties inherent in
our business, including, without limitation: our future performance
is dependent entirely on the success of lorundrostat; potential
delays in the commencement, enrollment and completion of clinical
trials and nonclinical studies; later developments with the FDA may
be inconsistent with the feedback from the completed end of Phase 2
meeting, including whether the proposed pivotal program will
support registration of lorundrostat which is a review issue with
the FDA upon submission of an NDA; our dependence on third parties
in connection with manufacturing, research and clinical and
nonclinical testing; unexpected adverse side effects or inadequate
efficacy of lorundrostat that may limit its development, regulatory
approval and/or commercialization; unfavorable results from
clinical trials and nonclinical studies; results of prior clinical
trials and studies of lorundrostat are not necessarily predictive
of future results; our ability to maintain undisrupted business
operations due to any pandemic or future public health concerns;
regulatory developments in the United States and foreign countries;
our reliance on our exclusive license with Mitsubishi Tanabe Pharma
to provide us with intellectual property rights to develop and
commercialize lorundrostat; and other risks described in our
filings with the Securities and Exchange Commission (SEC),
including under the heading “Risk Factors” in our annual report on
Form 10-K, and any subsequent filings with the SEC. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof, and we
undertake no obligation to update such statements to reflect events
that occur or circumstances that exist after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
Contact:Investor
Relationsinvestorrelations@mineralystx.com
Media RelationsTom WeibleElixir
Health Public RelationsPhone: (1) 515-707-9678Email:
tweible@elixirhealthpr.com
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