Latest news with #Lorundrostat
Yahoo
26-05-2025
- Health
- Yahoo
Mineralys reports outcomes from trial of lorundrostat for hypertension
Mineralys Therapeutics has reported outcomes from its pivotal randomised, placebo-controlled Phase III Launch-HTN trial assessing lorundrostat for controlling hypertension. This global, double-blinded trial involved more than 1,000 subjects having uncontrolled or resistant hypertension (uHTN or rHTN), who were on two to five antihypertensive medications. Subjects were randomised and given either a placebo, lorundrostat 50mg once daily, or a dose of lorundrostat 50mg and titrated to 100mg at week six. Change from baseline in systolic blood pressure against placebo post six weeks of treatment is the primary endpoint of the trial. It was met showing a decrease in placebo-adjusted systolic blood pressure from baseline at week six. Lorundrostat dosed at 50mg once a day minimised automatised office systolic blood pressure. At week six, subjects experienced a 16.9 mmHg reduction, with a further decrease to 19 mmHg by week 12, compared to placebo. The trial's design reflected real-world clinical settings, using automated office blood pressure (AOBP) measurement and enabling subjects to maintain their current medication regimens. According to the company, lorundrostat's tolerability and safety profile was favourable, with modest on-target effects on serum electrolytes, which were quickly reversible upon discontinuation. Notably, cortisol production suppression was not observed, and there were very few serious adverse events related to the drug that required discontinuation or adjustments of dosage. Lorundrostat is an oral aldosterone synthase inhibitor targeting the treatment of hypertension, obstructive sleep apnoea, and chronic kidney disease. Mineralys Therapeutics CEO Jon Congleton said: '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. '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.' In March this year, lorundrostat met the primary endpoint in two pivotal trials. "Mineralys reports outcomes from trial of lorundrostat for hypertension" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Upturn
24-05-2025
- Business
- Business Upturn
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 Relations [email protected] Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678 Email: t [email protected]
NDTV
13-05-2025
- Health
- NDTV
Promising New Drug Could Cut Blood Pressure In Weeks, Scientists Find
Scientists have discovered a promising new drug that could cut high blood pressure by 15 points in patients within a few days of its administration. As per researchers at the University of California, San Diego, the wonder drug, named lorundrostat, could treat uncontrolled or treatment-resistant hypertension. The researchers enrolled 285 participants, including patients from UC San Diego Health, for the Phase II, multicentre clinical trial, conducted across the US. The findings showed that those who received lorundrostat experienced a 15-point reduction in systolic blood pressure, compared to a seven-point drop in those given a placebo. "At four weeks, 42 per cent of those taking lorundrostat had their blood pressure under control, compared with 19 per cent in the placebo group," the study highlighted. Luke Laffin, MD, cardiologist at Cleveland Clinic and the study's first author, said lorundrostat managed to effectively lower the blood pressure with an "acceptable side effect profile". "This drug could be another tool in our armamentarium to reduce blood pressure and, ultimately, reduce the risk from uncontrolled hypertension in terms of outcomes like strokes, heart attacks and heart failure," said Mr Laffin. Lorundrostat's success The researchers stated that the side effects experienced by patients were consistent with other drugs that work using a similar mechanism. "Some participants saw an increase in potassium in the blood and some experienced a decrease in glomerular filtration rate, a measure of kidney functioning." High blood pressure, or hypertension, is one of the leading causes of heart disease and related deaths across the globe. Lorundrostat is a new class of blood pressure medication called aldosterone synthase inhibitor (ASI) that is designed to work by disrupting the production of aldosterone -- a hormone that can contribute to hypertension. While scientists are building on the success of the study, another pivotal lorundrostat trial is currently underway with results expected later this year.
Yahoo
23-04-2025
- Business
- Yahoo
Mineralys Therapeutics Announces Publication of Pivotal Phase 2 Advance-HTN Results in the New England Journal of Medicine (NEJM)
– Significant blood pressure reductions among patients with uncontrolled or resistant hypertension treated with lorundrostat reinforce key role of dysregulated aldosterone in disease onset and progression – – Detailed results from the second pivotal Phase 3 Launch-HTN trial to be presented at an upcoming medical conference and published in a peer-reviewed publication – RADNOR, Pa., April 23, 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 that the New England Journal of Medicine (NEJM) published the detailed results from the Company's pivotal Phase 2 Advance-HTN trial, the first of two pivotal trials evaluating lorundrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The full manuscript is titled, 'Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension,' and is featured in the April 23, 2025 issue of NEJM. The key data from the publication showed that lorundrostat 50 mg demonstrated a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction (p=0.001), in 24-hour ambulatory blood pressure at week 12. Lorundrostat worked equally well in those taking two baseline medications and those taking three or more, and in both men and women as well as in white and black patients. Lorundrostat demonstrated a favorable safety and tolerability profile, with modest changes in potassium, sodium and eGFR. 'The publication of our Advance-HTN trial results in the New England Journal of Medicine is a significant milestone that underscores both the strength of our clinical data and the potentially transformative nature of this new class of medicines that could help address dysregulated aldosterone, an unaddressed, key driver of hypertension,' stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. 'Prior studies have shown that even modest reductions in systolic blood pressure can lead to a substantial decrease in the incidence of major cardiovascular events. The blood pressure reductions with lorundrostat observed in the Advance-HTN trial are particularly meaningful given the well-established correlation between elevated blood pressure, dysregulated aldosterone production and cardiovascular risk.' 'The significant blood pressure lowering with lorundrostat 50 mg in the Advance-HTN trial was seen in patients treated by specialists who were taking an optimized standardized antihypertensive regimen – those patients with true uncontrolled or resistant hypertension that desperately need new options to lower their blood pressure,' stated Luke Laffin, M.D., co-director of the Center for Blood Pressure Disorders in the Heart, Vascular & Thoracic Institute at Cleveland Clinic and the study's lead author. 'Currently available therapies to treat hypertension do not decrease aldosterone production in the body, and we know aldosterone dysregulation is a driving factor in the blood pressure elevation of many of our patients. The findings reinforce the critical role of aldosterone in the pathogenesis of hypertension and the potential of lorundrostat to address unmet medical needs facing patients with uncontrolled or treatment-resistant disease.' The NEJM publication of the detailed Advance-HTN results follows a late-breaking presentation of the data at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25) in Chicago on March 29, 2025, and the announcement of positive topline results from both Advance-HTN and Launch-HTN earlier in March. Mineralys plans to provide additional data from the pivotal Phase 3 Launch-HTN at an upcoming medical conference and in a peer-reviewed publication. Additionally, the ongoing Transform-HTN open-label extension trial allows subjects to continue to receive lorundrostat and obtain additional safety and efficacy data. 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 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 $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 approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated statistically significant and clinically meaningful blood pressure reduction in both automated office blood pressure measurement and 24-hour ambulatory 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 serious adverse event possibly related to study drug being hyponatremia. 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 subjects. Subjects who met 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. Subjects who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg once-daily (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 Advance-HTN and Launch-HTN 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, OSA, uHTN or rHTN; and the planned future clinical development of lorundrostat and the timing thereof. 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; 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@ in to access your portfolio
Yahoo
29-03-2025
- Health
- Yahoo
New blood pressure drug helps people with uncontrolled hypertension in trial
A new type of medication may help lower blood pressure in people with uncontrolled hypertension, researchers reported Saturday at the annual meeting of American College of Cardiology in Chicago. In a pivotal Phase 2b clinical trial, patients who took the experimental medication lorundrostat along with two or three currently available hypertension drugs saw a decrease in systolic blood pressure (the upper number) that was 8 points greater than what was seen in patients who got a placebo. The study will be published in The New England Journal of Medicine. 'This new potential therapy for hypertension is exciting,' said the study's lead author, Dr. Luke Laffin, co-director of the Center for Blood Pressure Disorders at the Cleveland Clinic's Heart, Vascular and Thoracic Institute. 'We do a poor job controlling blood pressure in the U.S.' According to the Centers for Disease Control and Prevention, nearly half of adults in the U.S. have hypertension; among them, less than 1 in 4 have their blood pressure under control. Hypertension is diagnosed when a person has a blood pressure of 130/80 mm Hg or higher. A systolic measurement between 120 and 129 mm Hg is considered to be elevated. A normal measurement is 120/80 mm Hg or below. Uncontrolled hypertension — which Laffin defined as a measurement of 130/80 mm Hg or higher even with medication — is linked to a higher risk of heart attacks, strokes, heart failure and kidney failure. Among patients taking medication for hypertension, the rate of control is 60% to 70%, said Dr. Ajay Kirtane, a cardiologist and professor of medicine at the Columbia University Vagelos College of Physicians and Surgeons in New York City, who wasn't involved with the research. That leaves 30% to 40% of patients who need another option. Lorundrostat is meant for this group of patients. The drug, part of a class called aldosterone synthase inhibitors, works by blocking the adrenal glands' synthesis of a hormone called aldosterone, which controls the amount of salt retained by the body. When aldosterone is reduced, so are salt levels and therefore blood pressure. To test the safety and efficacy of lorundrostat, Laffin and his colleagues recruited 285 adults with uncontrolled hypertension whose average age was 60. More than half (53%) of the participants were Black. Black patients are among those most at risk, Laffin said. About 55% of Black adults have high blood pressure, according to the American Heart Association. Dr. Oscar Cingolani, director of the hypertension program at Johns Hopkins Medicine, said the inclusion of so many Black patients is 'a big, big thing,' noting that 'African Americans … tend to be more responsive to this pathway.' All of the patients in the trial were already taking a mix of blood pressure drugs. When the trial began, the researchers standardized those treatments by putting all of the patients on two or three specific medications. Three weeks later, they randomly assigned the participants to get either a placebo or one of two doses of lorundrostat for the next 12 weeks. At three points, the participants wore a blood pressure cuff for a 24-hour period: at the beginning, four weeks after treatment started and then again at 12 weeks. Participants taking the lower dose of lorundrostat, 50 milligrams, plus standard medications saw an average systolic blood pressure decrease of 15.4 points, while the group receiving the placebo plus standard drugs saw a decrease of 7.4 points — so the drug-related decrease in blood pressure after accounting for the placebo response was 8 points. Increasing the dose of the drug didn't improve the results. While the placebo response may seem high, it's most likely due to people being in a study and having the attention of health professionals, making them more scrupulous about taking their medications, experts said. With a decrease of 8 points, say from 170 to 162, 'that is the range where you would in a longer-term study see reductions in heart attacks and strokes,' said Dr. Deepak Bhatt, director of the Mount Sinai Fuster Heart Hospital in New York City. Aldosterone synthase inhibitors are a new class of drugs, some of which are closer to being considered for approval by the Food and Drug Administration than others, Bhatt said. One other, baxdrostat, is currently in Phase 3 trials. Lorundrostat has shown promise in the three levels of clinical trials needed for approval. The last one, the Phase 3 trial, is completed, though the results haven't been published yet, Laffin said. The researchers are working on the trials with drugmaker Mineralys Therapeutics, which funded the trials. The drug could potentially be available within 12 to 18 months, Laffin said. Patients in the trial who got lorundrostat were more likely than those who got the placebo to develop high potassium levels. That's something patients' doctors would need to keep an eye out for, Bhatt said, because it can lead to abnormal heart rhythms. Cingolani, of Johns Hopkins, said he would like to see long-term studies on the new medication and also ones that could compare lorundrostat to an older medication that works by blocking the receptor for aldosterone. This article was originally published on
