Mineralys Therapeutics Announces First Subject Dosed in Launch-HTN, the Second Pivotal Trial of Lorundrostat for the Treatment of Hypertension
December 21 2023 - 4:05PM
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 announced that the
first subject has been dosed in the Launch-HTN (NCT06153693)
pivotal trial to evaluate the safety and efficacy of lorundrostat
for the treatment of uncontrolled hypertension (uHTN) or resistant
hypertension (rHTN), when used as an add-on therapy to prescribed
background treatment.
“Initiating this second pivotal trial demonstrates the continued
progress we’re making towards introducing a targeted approach to
care in hypertension by identifying and profiling potential
responders to lorundrostat,” stated Jon Congleton, Chief Executive
Officer of Mineralys. “In parallel with our development of
lorundrostat, we have been pleased to see accumulating evidence
generated by the medical community highlighting aldosterone as a
key driver in cardiorenal disease.”
Launch-HTN is the second of two clinical trials under the
planned pivotal program to evaluate the safety and efficacy of
lorundrostat when added to subjects’ existing background
hypertension treatment. This trial is designed to model real world
treatment of uHTN and rHTN in the primary care setting. Launch-HTN
is a global, randomized, double-blinded, placebo-controlled Phase 3
trial that is designed to enroll up to approximately 1,000 eligible
adult participants who are failing to achieve their blood pressure
goal on two to five background antihypertensive medications.
Eligible subjects will be randomized to one of three arms: placebo,
lorundrostat 50 mg once daily (QD), and lorundrostat 50 mg QD and
then titrated to 100 mg QD, as needed, at week six. The primary
endpoint of the trial is change from baseline in systolic blood
pressure versus placebo after 12 weeks of treatment, as measured by
automated office blood pressure monitoring.
Previously, in May 2023, the Company announced the first subject
dosed in the first pivotal trial, Advance-HTN. The Company expects
to announce topline data from the Advance-HTN trial in the second
half of 2024. Subjects in both the Advance-HTN and Launch-HTN
trials are provided the opportunity to participate in the
open-label extension trial, Transform-HTN.
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% 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% of all hypertensive patients.
About LorundrostatLorundrostat is a
proprietary, orally administered, highly selective aldosterone
synthase inhibitor being developed for the treatment of
uncontrolled and resistant 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.
Contact:Investor
Relationsinvestorrelations@mineralystx.com
Media RelationsTom WeibleElixir
Health Public RelationsPhone: (1)
515-707-9678Email: tweible@elixirhealthpr.com
Mineralys Therapeutics (NASDAQ:MLYS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Mineralys Therapeutics (NASDAQ:MLYS)
Historical Stock Chart
From Jul 2023 to Jul 2024