Mineralys Therapeutics Presents Target-HTN Phase 2 Trial Results in Late-Breaking Science Session at 2023 AHA Hypertension Scientific Sessions
10 Setembro 2023 - 8:45AM
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 presented final results from
the Target-HTN Phase 2 trial of lorundrostat, a highly selective
aldosterone synthase inhibitor, in individuals with uncontrolled
hypertension (uHTN) and resistant hypertension (rHTN). The data
were presented during a late-breaking science session at the 2023
American Heart Association (AHA) Hypertension Scientific Sessions,
which is being held in Boston from September 7–10, and
simultaneously published in the Journal of the American Medical
Association (JAMA).
Target-HTN trial results demonstrate treatment with lorundrostat
at doses of 50mg and 100mg once daily (QD) led to a statistically
and clinically significant reduction of systolic blood pressure
(BP) in inadequately controlled hypertensive individuals on at
least two background antihypertensive medications. The reduction in
BP was particularly evident among participants with hypertension
and concomitant obesity.
“The final results from our Target-HTN trial demonstrate
lorundrostat had a robust, double-digit reduction in systolic blood
pressure with a well-tolerated profile in the intention-to-treat
population of individuals with uncontrolled hypertension and
resistant hypertension. In support of our targeted development
strategy for lorundrostat, a pre-specified sub-analysis of
subjects with elevated BMI demonstrated enhanced reduction in
systolic blood pressure that is likely due, in part, to visceral
fat driving abnormal aldosterone levels,” stated Jon Congleton,
Chief Executive Officer of Mineralys Therapeutics. “Results from
the Target-HTN trial were instrumental in our decision to advance
the ongoing pivotal program and we look forward to announcing the
results from our initial pivotal study expected in the first half
of 2024.”
Key clinical data from Target-HTN suggest robust BP
reductions in the treatment of patients with uHTN and
rHTN:
- Target-HTN successfully met its primary endpoint, demonstrating
a statistically significant change from baseline in systolic
automated office BP (AOBP) with lorundrostat 50mg (n=28) and 100mg
(n=25) QD doses versus placebo (n=29):
- -13.7 mmHg systolic AOBP change at 50mg QD, or -9.6 mmHg
placebo-adjusted change (p=0.01)
- -11.9 mmHg systolic AOBP change at 100mg QD, or -7.8 mmHg
placebo-adjusted change (p=0.04)
- Key secondary endpoint results demonstrated a change in
diastolic AOBP of -7.1 mmHg with 50mg QD (or -5.5 mmHg
placebo-adjusted change; p=0.02) and -5.8 mmHg with 100mg QD (or
-4.1 mmHg placebo-adjusted change; p=0.09)
- Other secondary endpoints, including assessment of 24-hour
average BP, supported the efficacy of the QD dosing regimen.
- A pre-specified analysis examined the impact of body mass index
(BMI) on the degree of BP lowering with lorundrostat, testing the
hypothesis that aldosterone-dependent hypertension may be more
significant in obese individuals:
- With 50mg QD, changes in systolic AOBP were 2.2 mmHg in
subjects with a BMI 25-30 kg/m2, versus -16.7 in subjects with a
BMI ≥30 kg/m2 (placebo-adjusted; p<0.01)
- With 100mg QD, changes in systolic AOBP were -4.5 mmHg in
subjects with a BMI 25-30 kg/m2, versus -12.3 in subjects with a
BMI ≥30 kg/m2 (placebo-adjusted; p=0.03)
Key safety and tolerability findings from Target-HTN
suggest lorundrostat was well‐tolerated with a favorable safety
profile, particularly with 50mg lorundrostat QD:
- Lorundrostat was well tolerated at all dose levels
- There was a modest, dose-dependent increase in mean serum
potassium (0.25-0.29 mmol/L) and low incidence of elevated serum
potassium (3.6% subjects with serum potassium levels above 6.0
mmol/L)
- Three serious adverse events occurred, only one (worsening of
pre-existing hyponatremia with 100mg lorundrostat QD) was deemed
treatment-related
Target-HTN trial results support the transition to late-stage
development of lorundrostat as a treatment for inadequately
controlled hypertension. The Company’s ongoing pivotal development
program for lorundrostat to treat uHTN and rHTN is currently
enrolling subjects in the Advance-HTN trial, and the Phase 3
Launch-HTN trial is expected to be initiated in the second half of
the year, with topline data expected in the first half of 2024 and
mid-2025, respectively.
The presentation at the 2023 AHA Hypertension Scientific
Sessions, titled, “Aldosterone Synthase Inhibition with
Lorundrostat for Uncontrolled Hypertension: The Target‐HTN Phase 2
Randomized Clinical Trial,” 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 and 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 up to 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 chronic kidney disease (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 percent 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 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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