Latest news with #lorundrostat
Medical News Today
4 days ago
- Business
- Medical News Today
Hypertension: New drug shows strong results in managing blood pressure
A clinical trial has seen promising results from a new class of medication to treat hypertension. Design by MNT; Photography by Peca King/500px/Getty Images & MementoJpeg/Getty Images A novel treatment for hard-to-control high blood pressure has shown strong results in a major global clinical trial. The Phase 3 Launch-HTN study found that lorundrostat, an aldosterone synthase inhibitor, safely and consistently lowered blood pressure in a large, diverse group of patients who had not responded to other medications. These findings mark a significant step forward in the development of the first targeted aldosterone synthase inhibitor for these conditions. Blood pressure refers to the force exerted by blood against the walls of the arteries. Hypertension, or high blood pressure, happens when this force is consistently higher than normal. Hypertension impacts one in three adults globally and significantly raises the risk of heart disease, heart attacks, and strokes. Resistant hypertension is a form of high blood pressure that remains elevated despite a person taking three different blood pressure medications at their maximum recommended doses. Up to 15% of individuals with hypertension have abnormal regulation of aldosterone, a hormone that helps control blood pressure. When aldosterone levels are elevated due to this dysregulation, it can lead to hypertension. A new study, presented at the 34th European Meeting on Hypertension and Cardiovascular Protection, shows that lorundrostat — a drug that inhibits aldosterone synthase — is both safe and effective for treating individuals with uncontrolled or resistant hypertension. The findings are yet to be published in a peer-reviewed journal. Lorundrostat is specifically designed to lower aldosterone levels by targeting and inhibiting CYP11B2, the enzyme that drives its production. The study demonstrated consistent reductions in blood pressure across a large and diverse group of patients and represents the largest phase three trial to date for this class of treatment. Manish Saxena, MD, Clinical Co-Director of the William Harvey Heart Centre at Queen Mary University of London and Hypertension Specialist from Barts Health NHS Trust and the study's lead Investigator, spoke to Medical News Today . 'Despite available treatments, more than 40% of adults with hypertension worldwide are not reaching their blood pressure goal. Aldosterone pathway plays important role in blood pressure regulation, and leads to blood pressure related complications such as heart failure and kidney problems. In the Launch-HTN trial we explored the safety and effectiveness of lorundostat, which belongs to a new class of drugs called aldosterone synthase inhibitors that block production of hormone aldosterone from the adrenal glands.' — Manish Saxena, MD 'The Launch-HTN trial is the largest phase 3 hypertension study with a novel drug,' Saxena explained. 'We tested lorundostat in a large, diverse patient population recruited globally and found that it has good safety profile and lowered blood pressure consistently in all of our patient groups.' How lorundrostat works 'Hormone aldosterone secreted from adrenal glands in the body plays an important role in driving blood pressure. Now there is more awareness of dysregulated aldosterone secretion in patients with difficult to treat blood pressure. Lorundrostat blocks biosynthesis of hormone aldosterone in the body and helps reduce blood pressure.' — Manish Saxena, MD The Launch-HTN trial was a global, Phase 3 study that was randomized, double-blind, and placebo-controlled. It included adult participants whose blood pressure remained uncontrolled despite taking two to five antihypertensive medications. Designed to reflect real-world clinical practice, the trial used automated office blood pressure (AOBP) measurements and allowed participants to continue their existing treatments. Lorundrostat, administered once daily at a 50 mg dose, showed meaningful and sustained reductions in systolic blood pressure — dropping by 16.9 mmHg at Week 6 (a 9.1 mmHg reduction compared to placebo) and by 19 mmHg at Week 12 (an 11.7 mmHg reduction versus placebo). 'The LAUNCH-HTN trial demonstrated blood pressure lowering efficacy and safety of lorundrostat in a very diverse patient group with uncontrolled and difficult to treat hypertension that were on background 2-5 blood pressure lowering medication. The blood pressure reduction observed was consistent across key sub-groups, significant and clinically meaningful.' — Manish Saxena, MD Two experts, not involved in the study, also spoke to MNT . Cheng-Han Chen, MD, board certified interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, CA, noted that 'aldosterone synthase inhibitors are a new class of drugs being studied for the treatment of hypertension.' 'This trial found that lorundrostat, one of these new types of drugs, was safe and effective for patients with uncontrolled or resistant hypertension. This puts us one step closer to having another tool in our arsenal for patients with difficult to control blood pressure despite being on multiple medications,' Chen explained. 'Many patients have high blood pressure that are not under control with multiple classes of medications. By having another class of blood pressure medications at our disposal, we will better be able to reduce rates of hypertension in our population and improve health outcomes.' — Cheng-Han Chen, MD Rigved Tadwalkar, MD, FACC, consultative cardiologist and director of Digital Transformation Pacific Heart Institute in Santa Monica, CA told MNT that 'this is a meaningful step forward.' 'We still see far too many patients with uncontrolled or resistant hypertension, even when they're on three, four, sometimes five medications. The reality is that for a significant subset of these patients, aldosterone is driving the problem and until now, we haven't had a way to target that mechanism directly in a safe, practical way,' Tadwalkar explained. 'Lorundrostat appears to change that. It inhibits aldosterone synthesis at the enzymatic level, and based on this trial, it does so with a good safety profile and consistent efficacy across a diverse population. The blood pressure reductions– nearly 17 mmHg at 6 weeks and close to 19 mmHg at 12– are significant, especially when you consider that these were already heavily treated patients. That kind of additional drop is not something we usually see at this stage of therapy.' — Rigved Tadwalkar, MD, FACC 'Since patients stayed on their background medications, these results feel more clinically relevant than more tightly controlled washout studies,' Tadwalkar added. 'It's a welcome addition to the field, even as we continue to see the limitations of existing therapies, including newer device-based approaches like renal denervation.' Tadwalkar said that lorundrostat had potential to make a real difference in patients' lives. 'If lorundrostat becomes widely available, it could offer a new option for patients who've exhausted standard pathways. For people living with resistant hypertension, many of whom are already dealing with co-morbidities like kidney disease or heart failure, having another tool, especially one that targets the underlying hormonal dysregulation, could make a real difference in long-term outcomes,' he said. Saxena said that once lorundostat becomes commercially available, it could become a novel treatment option for hypertension for many patients. Tadwalkar continued by noting that 'at the population level, we're still facing a huge burden from poorly controlled blood pressure.' He said untreated hypertension was a major contributor to chronic diseases and cardiovascular problems. 'A drug like this, if used properly, could help narrow that treatment gap. It's certainly not a silver bullet, but it's a step toward more personalized, mechanism-specific care. This is something the hypertension field has needed for a long time.' — Rigved Tadwalkar, MD, FACC Hypertension Clinical Trials / Drug Trials Drugs
Yahoo
24-05-2025
- Business
- Yahoo
Mineralys Therapeutics Announces Late-Breaking Presentation of Data from the Launch-HTN Pivotal Trial of Lorundrostat in Uncontrolled or Resistant Hypertension at 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025)
– Largest hypertension trial of an aldosterone synthase inhibitor to date demonstrated the efficacy of lorundrostat in over 1,000 participants with uncontrolled or resistant hypertension in a real-world setting – – Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted) and a 19.0 mmHg reduction at Week 12 (-11.7mm placebo adjusted) – – Lorundrostat demonstrated a favorable safety and tolerability profile – RADNOR, Pa., May 24, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced detailed results from the pivotal Phase 3 Launch-HTN trial in over 1,000 participants with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) who were taking two to five antihypertensive medications. When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in automatized office systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) and a 19 mmHg reduction at Week 12 (-11.7mm placebo adjusted; p-value < 0.0001). Additionally, lorundrostat demonstrated a favorable safety and tolerability profile. 'The detailed results from Launch-HTN, which was designed to reflect treatment in the real-world setting, mark a pivotal milestone in our mission to deliver the first targeted aldosterone synthase inhibitor to the millions of people suffering from uncontrolled or resistant hypertension,' stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. 'With these findings in hand, we now have data from two pivotal trials in distinct-but-complementary populations that reinforce the promise of a new treatment approach for hypertension that directly addresses the dysregulated aldosterone pathway – a key driver of the condition in many patients.' 'The Launch-HTN trial provides substantial evidence supporting lorundrostat's potential as a well-tolerated, effective treatment for patients with uncontrolled or resistant hypertension, with consistent blood pressure reductions across a large and diverse patient population,' stated Manish Saxena MBBS, Deputy Clinical Co-Director of Queen Mary University of London's William Harvey Research Institute and Hypertension Specialist at Barts Health NHS Trust. 'The clinically meaningful and sustained reductions in systolic blood pressure observed with lorundrostat are especially important, as long-term control is key to lowering the risk of serious cardiovascular, renal, and metabolic complications. The consistency of results seen in the lorundrostat development program – which includes multiple trials across differentiated patient populations – supports its potential to have a broad role in future hypertension care.' Results from Launch-HTN were presented in a late-breaking session at the 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025) on Saturday, May 24, 2025, at 10:00am CEST. Efficacy Results from Launch-HTN The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their blood pressure goal despite being on two to five antihypertensive medications. Launch-HTN reflects the real-world setting for clinicians by utilizing automated office blood pressure (AOBP) measurement and allowing participants to stay on their existing medications. The trial met its endpoints demonstrating clinically meaningful, statistically significant mean reduction from baseline in placebo-adjusted systolic blood pressure at week six and the benefit was sustained with potential further reduction through week 12. Primary Endpoint 50 mg(n=808) Change in AOBP at Week 6 -16.9 mmHg absolute change -9.1 mmHg placebo-adjusted change(p < 0.0001) Pre-Defined Endpoint 50 mg(n=538) 50 to 100 mg(n=270) Change in AOBP at Week 12 -19.0 mmHg absolute change -15.7 mmHg absolute change -11.7 mmHg placebo-adjusted change(p < 0.0001) -8.4 mmHg placebo-adjusted change(p = 0.0016) Safety and Tolerability Results Lorundrostat demonstrated a favorable safety and tolerability profile in the Launch-HTN trial. The anticipated on-target effects on serum electrolytes, increased serum potassium and reduced serum sodium were modest and rapidly reversible upon discontinuation of lorundrostat. Suppression of cortisol production was not observed and there was a very low incidence of drug-related serious adverse events resulting in discontinuation or dose-adjustment of study medication. Treatment-emergent serious adverse events (SAEs) occurred in 12 participants (2.2%) and two participants (0.7%) in the 50 mg and 50 mg with optional dose escalation to 100 mg arms, respectively, compared with eight participants (3.0%) in the placebo arm. There was only one participant (0.1%) in the trial with treatment-related SAE that occurred in the 50 mg arm. The incidence of hyperkalemia (serum potassium >6.0 mmol/L) at the scheduled study visit was 1.1% and 1.5% in the 50 mg and 50 to 100 mg arms, respectively. After per-protocol exclusion of factitious results, the values for confirmed hyperkalemia were 0.6% and 1.1%, respectively. Launch-HTN was the second of two pivotal trials evaluating lorundrostat in participants with uHTN or rHTN. Detailed results from the first pivotal trial (Advance-HTN) in participants who would normally be treated by specialists were recently published in The New England Journal of Medicine (NEJM). Advance-HTN results were first presented at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25) in March 2025. 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 U.S. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the U.S. in 2019. Less than 50% of hypertension patients achieve their blood pressure goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN or rHTN, as well as CKD and OSA. 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 a 40-70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive participants, once-daily lorundrostat demonstrated statistically significant and clinically meaningful systolic blood pressure reduction in both AOBP and 24-hour ambulatory systolic blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one SAE possibly related to study drug being hyponatremia. About Launch-HTN The Launch-HTN trial (NCT06153693) was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their blood pressure goal despite being on two to five background antihypertensive medications. Eligible participants were 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 was the change from baseline in systolic blood pressure versus placebo after six weeks of treatment, as measured by AOBP monitoring. About Advance-HTN The Advance-HTN trial (NCT05769608) was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult participants. Participants who meet screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Participants who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg QD, lorundrostat 50 mg QD and an option to titrate to 100 mg QD at week four based on defined criteria or placebo. The trial's primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo. About Mineralys Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit Follow Mineralys on LinkedIn and Twitter. 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 Advance-HTN and Launch-HTN may serve as pivotal trials in any submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the Company's ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; 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: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; 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; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; 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; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; 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@ Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@
Yahoo
24-05-2025
- Business
- Yahoo
Mineralys Therapeutics Announces Late-Breaking Presentation of Data from the Launch-HTN Pivotal Trial of Lorundrostat in Uncontrolled or Resistant Hypertension at 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025)
– Largest hypertension trial of an aldosterone synthase inhibitor to date demonstrated the efficacy of lorundrostat in over 1,000 participants with uncontrolled or resistant hypertension in a real-world setting – – Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted) and a 19.0 mmHg reduction at Week 12 (-11.7mm placebo adjusted) – – Lorundrostat demonstrated a favorable safety and tolerability profile – RADNOR, Pa., May 24, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced detailed results from the pivotal Phase 3 Launch-HTN trial in over 1,000 participants with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) who were taking two to five antihypertensive medications. When added to existing background treatment, lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in automatized office systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value < 0.0001) and a 19 mmHg reduction at Week 12 (-11.7mm placebo adjusted; p-value < 0.0001). Additionally, lorundrostat demonstrated a favorable safety and tolerability profile. 'The detailed results from Launch-HTN, which was designed to reflect treatment in the real-world setting, mark a pivotal milestone in our mission to deliver the first targeted aldosterone synthase inhibitor to the millions of people suffering from uncontrolled or resistant hypertension,' stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. 'With these findings in hand, we now have data from two pivotal trials in distinct-but-complementary populations that reinforce the promise of a new treatment approach for hypertension that directly addresses the dysregulated aldosterone pathway – a key driver of the condition in many patients.' 'The Launch-HTN trial provides substantial evidence supporting lorundrostat's potential as a well-tolerated, effective treatment for patients with uncontrolled or resistant hypertension, with consistent blood pressure reductions across a large and diverse patient population,' stated Manish Saxena MBBS, Deputy Clinical Co-Director of Queen Mary University of London's William Harvey Research Institute and Hypertension Specialist at Barts Health NHS Trust. 'The clinically meaningful and sustained reductions in systolic blood pressure observed with lorundrostat are especially important, as long-term control is key to lowering the risk of serious cardiovascular, renal, and metabolic complications. The consistency of results seen in the lorundrostat development program – which includes multiple trials across differentiated patient populations – supports its potential to have a broad role in future hypertension care.' Results from Launch-HTN were presented in a late-breaking session at the 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025) on Saturday, May 24, 2025, at 10:00am CEST. Efficacy Results from Launch-HTN The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their blood pressure goal despite being on two to five antihypertensive medications. Launch-HTN reflects the real-world setting for clinicians by utilizing automated office blood pressure (AOBP) measurement and allowing participants to stay on their existing medications. The trial met its endpoints demonstrating clinically meaningful, statistically significant mean reduction from baseline in placebo-adjusted systolic blood pressure at week six and the benefit was sustained with potential further reduction through week 12. Primary Endpoint 50 mg(n=808) Change in AOBP at Week 6 -16.9 mmHg absolute change -9.1 mmHg placebo-adjusted change(p < 0.0001) Pre-Defined Endpoint 50 mg(n=538) 50 to 100 mg(n=270) Change in AOBP at Week 12 -19.0 mmHg absolute change -15.7 mmHg absolute change -11.7 mmHg placebo-adjusted change(p < 0.0001) -8.4 mmHg placebo-adjusted change(p = 0.0016) Safety and Tolerability Results Lorundrostat demonstrated a favorable safety and tolerability profile in the Launch-HTN trial. The anticipated on-target effects on serum electrolytes, increased serum potassium and reduced serum sodium were modest and rapidly reversible upon discontinuation of lorundrostat. Suppression of cortisol production was not observed and there was a very low incidence of drug-related serious adverse events resulting in discontinuation or dose-adjustment of study medication. Treatment-emergent serious adverse events (SAEs) occurred in 12 participants (2.2%) and two participants (0.7%) in the 50 mg and 50 mg with optional dose escalation to 100 mg arms, respectively, compared with eight participants (3.0%) in the placebo arm. There was only one participant (0.1%) in the trial with treatment-related SAE that occurred in the 50 mg arm. The incidence of hyperkalemia (serum potassium >6.0 mmol/L) at the scheduled study visit was 1.1% and 1.5% in the 50 mg and 50 to 100 mg arms, respectively. After per-protocol exclusion of factitious results, the values for confirmed hyperkalemia were 0.6% and 1.1%, respectively. Launch-HTN was the second of two pivotal trials evaluating lorundrostat in participants with uHTN or rHTN. Detailed results from the first pivotal trial (Advance-HTN) in participants who would normally be treated by specialists were recently published in The New England Journal of Medicine (NEJM). Advance-HTN results were first presented at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25) in March 2025. 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 U.S. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the U.S. in 2019. Less than 50% of hypertension patients achieve their blood pressure goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN or rHTN, as well as CKD and OSA. 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 a 40-70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive participants, once-daily lorundrostat demonstrated statistically significant and clinically meaningful systolic blood pressure reduction in both AOBP and 24-hour ambulatory systolic blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one SAE possibly related to study drug being hyponatremia. About Launch-HTN The Launch-HTN trial (NCT06153693) was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their blood pressure goal despite being on two to five background antihypertensive medications. Eligible participants were 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 was the change from baseline in systolic blood pressure versus placebo after six weeks of treatment, as measured by AOBP monitoring. About Advance-HTN The Advance-HTN trial (NCT05769608) was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult participants. Participants who meet screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Participants who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg QD, lorundrostat 50 mg QD and an option to titrate to 100 mg QD at week four based on defined criteria or placebo. The trial's primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo. About Mineralys Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit Follow Mineralys on LinkedIn and Twitter. 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 Advance-HTN and Launch-HTN may serve as pivotal trials in any submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the Company's ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; 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: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; 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; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; 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; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; 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@ Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@
The Independent
12-05-2025
- Health
- The Independent
Groundbreaking drug could cut uncontrolled blood pressure in weeks, scientists say
A potential new treatment could cut high blood pressure by 15 points within days, a new clinical trial suggests. The drug, named lorundrostat, could treat uncontrolled or treatment-resistant hypertension, say researchers from the University of California, San Diego. In the trial, scientists found that participants who received lorundrostat experienced an average 15-point reduction in systolic blood pressure – the upper number in a blood pressure reading – compared to a 7-point reduction in those given a placebo. The trial enrolled 285 participants, including UC San Diego Health patients, and was carried out in collaboration with the Cleveland Clinic Coordinating Center for Clinical Research. Hypertension is one of the leading causes of heart disease and related deaths across the world, but high blood pressure usually does not show any signs or symptoms. Previous studies have shown that the hormone aldosterone plays a crucial role in regulating the body's blood pressure, and when it is dysregulated, it can contribute to hypertension. 'We were specifically studying a new approach to addressing imbalanced aldosterone, which is an often under-recognized cause for treatment-resistant hypertension,' said Michael Wilkinson, an author of the study. Over 12 weeks, all participants received a standard antihypertensive medication, while additionally, 190 received a measured amount of lorundrostat, which stops aldosterone production. The other 95 participants received a placebo. 'All participants used the same standardised medications for their blood pressure for the first three weeks of the trial before beginning the drug or placebo, which allowed us the opportunity for a baseline and to truly understand the effectiveness of the treatment,' Dr Wilkinson explained. Researchers found that treatment lowered participants' systolic blood pressure compared to placebo. Those who received lorundrostat saw their systolic blood pressure levels drop, on average, by around 15 units. 'While blood pressure readings remained elevated at the end of this trial in some participants treated with lorundrostat, we find these results promising because almost all participants involved in the study were not able to sufficiently lower their blood pressure with medication before,' Dr Wilkinson said. 'As we learn more about the safety and efficacy of this treatment, I'm hopeful we will identify a useful tool in addressing high blood pressure for patients in need,' he said. In subsequent trials, researchers hope to assess the drug's efficiency in lowering blood pressure in a more diverse patient population and find if it could lead to a better treatment for hypertension.
