Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage
biopharmaceutical company focused on developing medicines to target
hypertension, chronic kidney disease (CKD) and other diseases
driven by abnormally elevated aldosterone, today presented data
from the Target-HTN Phase 2 trial that further defines an
endotype-specific targeted approach for treating uncontrolled or
resistant hypertension with lorundrostat, a highly selective
aldosterone synthase inhibitor. The data were presented in a poster
at the American Heart Association (AHA) Scientific Sessions 2023,
which is being held in Philadelphia from November 11th –13th.
Data previously presented from Target-HTN showed that elevated
body mass index (BMI) was predictive of an enhanced reduction in
systolic blood pressure (BP) from lorundrostat treatment. The
poster presented at the AHA Scientific Sessions 2023 included a new
analysis of serum leptin levels among subjects in the trial, which
showed that increased BMI was correlated with increased leptin
circulation. This is consistent with emerging evidence of a
leptin-driven, positive feedback loop between obesity, aldosterone
and hypertension.1
“Through our ongoing analyses of data from the Target-HTN trial,
a profile of which patients can benefit the most from lorundrostat
is emerging. After examining serum leptin levels across
participants, we now have evidence that this hormone, along with
elevated BMI, could be a biomarker for patients who may experience
a meaningful blood pressure reduction from lorundrostat treatment,”
stated David Rodman, M.D., Chief Medical Officer for Mineralys.
“Obesity is an epidemic and is one of the strongest risk factors
for developing hypertension, which results in subsequent poor
outcomes if uncontrolled. Being able to identify a hypertensive
endotype, and intervene early with aldosterone-targeted therapy,
would change the way clinicians currently treat the condition in
practice by introducing a precision approach to care.”
A pre-specified analysis from Target-HTN showed that subjects
with a BMI >30kg/m2 experienced placebo-adjusted reductions in
systolic BP of 16.7mmHg (p=0.002) and 12.3mmHg (p=0.03) with
lorundrostat 50mg and 100mg once-daily (QD) doses, respectively.
Findings from the new analysis showed that the same BMI range was
associated with a 75% increase in mean serum leptin (21.6 ±1.9ng/mL
in subjects with a BMI ≤30kg/m2 compared to 37.8 ±2.4ng/mL in
subjects with a BMI >30kg/m2; p<0.001), indicating that
increased circulating leptin may be a useful biomarker to identify
lorundrostat-responsive individuals.
The Target-HTN trial demonstrated that treatment with
lorundrostat at doses of 50mg and 100mg QD led to a statistically
and clinically significant reduction of systolic BP in uncontrolled
hypertensive individuals on at least two background
antihypertensive medications. Full results from the trial were
published in the Journal of the American Medical Association (JAMA)
and simultaneously presented during a late-breaking science session
at the 2023 AHA Hypertension Scientific Sessions in September.
Target-HTN trial results support the transition to late-stage
development of lorundrostat as a treatment for uncontrolled or
resistant hypertension. The Company’s ongoing pivotal development
program for lorundrostat to treat uncontrolled or resistant
hypertension is currently enrolling subjects in the pivotal
Advance-HTN trial, and the second pivotal trial, Launch-HTN, trial
is expected to be initiated in the second half of 2023.
The poster at AHA Scientific Sessions 2023 titled, “Lorundrostat
for Treatment of Obesity-Related, Aldosterone-Dependent
Hypertension - An Endotype-Specific, Targeted Approach to the
Treatment of Uncontrolled Hypertension,” can be accessed on the
publications page of the Mineralys corporate website.
About Target-HTNThe Target-HTN (NCT05001945)
Phase 2 proof-of-concept trial was a randomized, double-blind,
placebo-controlled, dose-ranging, multicenter trial conducted in
the U.S. The trial was designed to evaluate the safety, efficacy,
tolerability and dose response of orally administered lorundrostat
on BP for the treatment of uncontrolled or resistant hypertension
when used as add-on therapy to stable background treatment of two
or more antihypertensive agents in 200 male and female subjects 18
years of age or older. Five active doses of lorundrostat (12.5mg
QD, 50mg QD, 100mg QD, 12.5mg twice daily (BID), and 25mg BID) were
compared to placebo in hypertensive subjects. Adverse events
observed were a modest increase in serum potassium, decrease in
estimated glomerular filtration rate, urinary tract infection and
hypertension with one serious adverse event possibly related to
study drug being hyponatremia.
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, CKD 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 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 or uncontrolled
hypertension; 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.
References:1 Faulkner JL, et al. Curr Opin
Nephrol Hypertens. 2081;27(2):63-69.
Contact:Investor
Relationsinvestorrelations@mineralystx.com
Media RelationsTom WeibleElixir
Health Public RelationsPhone: (1) 515-707-9678Email:
tweible@elixirhealthpr.com
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