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 that full results
from the Target-HTN Phase 2 trial of lorundrostat, a highly
selective aldosterone synthase inhibitor, in individuals with
uncontrolled hypertension (uHTN) and treatment-resistant
hypertension (rHTN) were published in the Journal of the American
Medical Association (JAMA).
“Despite the multitude of currently available treatments, half
of all patients treated for hypertension are not able to reach
their blood pressure goal. Up to 25 percent of all people with
hypertension exhibit abnormal aldosterone levels,” said Luke
Laffin, M.D., lead investigator and co-director of the Center for
Blood Pressure Disorders in the Heart, Vascular & Thoracic
Institute at Cleveland Clinic. “Importantly, the Target-HTN study
of lorundrostat demonstrated data compelling enough to warrant its
advancement into late-stage clinical trials, representing a
first-in-class milestone that will further the goal of
understanding a new way of treating uncontrolled and
treatment-resistant hypertension that takes the underlying causes
into account.”
In the Target-HTN Phase 2 trial, lorundrostat demonstrated a
significant, double-digit reduction in SBP with a well-tolerated
profile in the intent-to-treat population of uHTN and rHTN.
Subjects with an elevated BMI, and participants taking a
thiazide-type diuretic, demonstrated an enhanced reduction in
SBP.
The publication notes that blood pressure guidelines recommend
similar medication combinations for most patients, regardless of
underlying comorbidities or the dominant underlying contributor to
hypertension, and that new treatments are needed as management of
blood pressure in the U.S. is relatively poor, and hypertension
remains a major cause of excess morbidity and mortality.
“We are gratified that JAMA chose to highlight our Target-HTN
Phase 2 trial results. These results demonstrated potentially
transformative blood pressure reduction in difficult-to-treat
hypertension, particularly so in obese individuals, who are known
to have elevated aldosterone and suffer from excess cardiovascular
morbidity and mortality,” stated David Rodman, M.D., Chief Medical
Officer for Mineralys. "We believe this trial confirms the link
between obesity, excess aldosterone production and hypertension.
Based on the beneficial response observed in Target-HTN, our
recently initiated pivotal program lays the groundwork to
facilitate identification of patients who may benefit from an
aldosterone-targeted therapy like lorundrostat.”
The trial results support further study of lorundrostat as a
treatment for uHTN, including the Company’s ongoing pivotal
development program for lorundrostat to treat uHTN and rHTN. Under
this program, the Company is currently enrolling subjects in the
pivotal Advance-HTN trial and expects to initiate the pivotal
Launch-HTN trial in the second half of the year, with topline data
expected in the first half of 2024 and mid-2025, respectively.
The 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 for the treatment of uHTN and rHTN
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
once daily QD, 50mg QD, 100mg QD, 12.5mg twice daily [BID], and
25mg BID) were compared to placebo in hypertensive subjects.
Pharmacokinetic, pharmacodynamic and response data established that
a once-daily dosing regimen was optimal. 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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