– Analysis further supports obesity-associated dysregulated aldosterone as an endotype predictive of enhanced response to lorundrostat treatment in patients with uncontrolled or treatment-resistant hypertension –
–Endotype identification from Target-HTN may represent a shift towards targeted, precision-directed therapy for hypertension management in future treatment paradigm –
– Ongoing Advance-HTN trial, first of two pivotal studies, will further characterize hypertensive endotype for enhanced response to lorundrostat treatment –
In this new analysis, investigators identified a population of responders to lorundrostat who experienced a median reduction in systolic blood pressure (BP) of 32 millimeters of mercury (mmHg). The enhanced response was proportional to the elevation in body mass index (BMI) and may indicate an obesity-related, aldosterone-dependent hypertensive endotype.
“We were able to show in this post-hoc analysis additional evidence corroborating the association between BMI and blood pressure reduction with lorundrostat. Individuals trying to manage obesity and hypertension in tandem are at an increased risk for poor outcomes, and a treatment that can provide an enhanced response to this population holds great promise,” stated
Consistent with the pre-specified categorical analysis from Target-HTN that demonstrated an enhanced treatment response in individuals with an elevated BMI, a post-hoc linear regression analysis demonstrated a statistically significant association between BMI and reduction in systolic BP in subjects with a BMI ranging from 22.5 to 40kg/m2. The modeled reduction in observed systolic BP was approximately 12mmHg at a BMI of 30kg/m2, and 19mmHg at a BMI of 40kg/m2. The distribution of responses was substantially left-skewed, with the upper quartile of subjects having a median reduction in systolic BP of approximately 32mmHg.
The Target-HTN trial demonstrated that treatment with lorundrostat at doses of 50mg and 100mg once daily (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
Target-HTN trial results support the transition to late-stage development of lorundrostat as a treatment for uncontrolled and resistant 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 before the end of the year.
The late-breaking poster at ASN Kidney Week 2023, titled, “Identification of a Hypertensive Endotype with a Median Treatment Effect of -32 mmHg in Response to the Novel Aldosterone Synthase Inhibitor Lorundrostat,” can be accessed on the publications page of the Mineralys corporate website.
About Target-HTN
The Target-HTN (NCT05001945) Phase 2 proof-of-concept trial was a randomized, double-blind, placebo-controlled, dose-ranging, multicenter trial conducted in the
About Hypertension
Having sustained, elevated blood pressure (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the
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 Lorundrostat
Lorundrostat 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 Therapeutics
Mineralys 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
Forward-Looking Statements
Mineralys 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
Contact:
Investor Relations
investorrelations@mineralystx.com
Media Relations
Elixir Health Public Relations
Phone: (1) 515-707-9678
Email: tweible@elixirhealthpr.com
Source:
2023 GlobeNewswire, Inc., source