Mineralys Therapeutics Announces Positive Topline Results from Launch-HTN and Advance-HTN Pivotal Trials of Lorundrostat for the Treatment of Uncontrolled or Resistant Hypertension
Mineralys Therapeutics (NASDAQ: MLYS) announced positive topline results from two pivotal trials evaluating lorundrostat for uncontrolled or resistant hypertension treatment. The Launch-HTN Phase 3 trial met its primary endpoint, with the 50mg dose achieving a 9.1 mmHg placebo-adjusted reduction in systolic blood pressure at week 6 (p<0.0001), and an 11.7 mmHg reduction at week 12.
The Advance-HTN Phase 2 trial also succeeded, showing a significant 7.9 mmHg placebo-adjusted reduction in 24-hour blood pressure monitoring at week 12. Both trials demonstrated favorable safety profiles, with low rates of serious adverse events. Hyperkalemia incidence was 1.1-1.5% in Launch-HTN and 5.3-7.4% in Advance-HTN.
This development targets approximately 15-20 million patients with uncontrolled hypertension in the United States. Full results from Advance-HTN will be presented at the American College of Cardiology Scientific Sessions on March 29, 2025.
Mineralys Therapeutics (NASDAQ: MLYS) ha annunciato risultati positivi preliminari da due studi clinici fondamentali che valutano lorundrostat per il trattamento dell'ipertensione non controllata o resistente. Il trial di fase 3 Launch-HTN ha raggiunto il suo obiettivo primario, con la dose di 50 mg che ha ottenuto una riduzione di 9,1 mmHg della pressione sanguigna sistolica corretta per il placebo alla settimana 6 (p<0.0001), e una riduzione di 11,7 mmHg alla settimana 12.
Il trial di fase 2 Advance-HTN ha anch'esso avuto successo, mostrando una significativa riduzione di 7,9 mmHg della pressione sanguigna monitorata per 24 ore corretta per il placebo alla settimana 12. Entrambi gli studi hanno dimostrato profili di sicurezza favorevoli, con basse percentuali di eventi avversi gravi. L'incidenza di iperkaliemia è stata dell'1,1-1,5% in Launch-HTN e del 5,3-7,4% in Advance-HTN.
Questo sviluppo si rivolge a circa 15-20 milioni di pazienti con ipertensione non controllata negli Stati Uniti. I risultati completi di Advance-HTN saranno presentati alle American College of Cardiology Scientific Sessions il 29 marzo 2025.
Mineralys Therapeutics (NASDAQ: MLYS) anunció resultados positivos preliminares de dos ensayos clínicos clave que evalúan lorundrostat para el tratamiento de la hipertensión no controlada o resistente. El ensayo de fase 3 Launch-HTN cumplió con su objetivo primario, con la dosis de 50 mg logrando una reducción ajustada por placebo de 9.1 mmHg en la presión arterial sistólica en la semana 6 (p<0.0001), y una reducción de 11.7 mmHg en la semana 12.
El ensayo de fase 2 Advance-HTN también tuvo éxito, mostrando una reducción significativa ajustada por placebo de 7.9 mmHg en el monitoreo de presión arterial de 24 horas en la semana 12. Ambos ensayos demostraron perfiles de seguridad favorables, con bajas tasas de eventos adversos graves. La incidencia de hiperpotasemia fue del 1.1-1.5% en Launch-HTN y del 5.3-7.4% en Advance-HTN.
Este desarrollo está dirigido a aproximadamente 15-20 millones de pacientes con hipertensión no controlada en los Estados Unidos. Los resultados completos de Advance-HTN se presentarán en las American College of Cardiology Scientific Sessions el 29 de marzo de 2025.
미네랄리스 테라퓨틱스 (NASDAQ: MLYS)는 조절되지 않거나 내성 고혈압 치료를 위한 로룬드로스타트 평가에 대한 두 가지 주요 시험에서 긍정적인 초기 결과를 발표했습니다. Launch-HTN 3상 시험은 주요 목표를 달성했으며, 50mg 용량이 6주차에 위약 조정된 수축기 혈압을 9.1 mmHg 감소시켰고(p<0.0001), 12주차에는 11.7 mmHg 감소했습니다.
Advance-HTN 2상 시험도 성공적으로 진행되어, 12주차에 24시간 혈압 모니터링에서 위약 조정된 7.9 mmHg의 유의미한 감소를 보여주었습니다. 두 시험 모두 심각한 부작용의 비율이 낮은 안전성 프로필을 나타냈습니다. 고칼륨혈증 발생률은 Launch-HTN에서 1.1-1.5%, Advance-HTN에서 5.3-7.4%였습니다.
이 개발은 미국에서 조절되지 않는 고혈압 환자 약 1500-2000만 명을 대상으로 하고 있습니다. Advance-HTN의 전체 결과는 2025년 3월 29일 미국 심장학회 과학 세션에서 발표될 예정입니다.
Mineralys Therapeutics (NASDAQ: MLYS) a annoncé des résultats préliminaires positifs de deux essais cliniques majeurs évaluant le lorundrostat pour le traitement de l'hypertension non contrôlée ou résistante. L'
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Ce développement cible environ 15-20 millions de patients souffrant d'hypertension non contrôlée aux États-Unis. Les résultats complets de l'Advance-HTN seront présentés lors des American College of Cardiology Scientific Sessions le 29 mars 2025.
Mineralys Therapeutics (NASDAQ: MLYS) hat positive vorläufige Ergebnisse aus zwei wichtigen Studien zur Bewertung von Lorundrostat zur Behandlung von unkontrollierter oder resistenter Hypertonie bekannt gegeben. Die Launch-HTN Phase-3-Studie erreichte ihr primäres Ziel, wobei die 50 mg-Dosis eine placebo-adjustierte Reduktion des systolischen Blutdrucks um 9,1 mmHg in Woche 6 (p<0.0001) und eine Reduktion um 11,7 mmHg in Woche 12 erzielte.
Die Advance-HTN Phase-2-Studie war ebenfalls erfolgreich und zeigte eine signifikante placebo-adjustierte Reduktion des Blutdrucks um 7,9 mmHg bei der 24-Stunden-Blutdrucküberwachung in Woche 12. Beide Studien wiesen günstige Sicherheitsprofile mit niedrigen Raten schwerer unerwünschter Ereignisse auf. Die Inzidenz von Hyperkaliämie lag bei 1,1-1,5% in der Launch-HTN und bei 5,3-7,4% in der Advance-HTN.
Diese Entwicklung richtet sich an etwa 15-20 Millionen Patienten mit unkontrollierter Hypertonie in den Vereinigten Staaten. Die vollständigen Ergebnisse der Advance-HTN werden am 29. März 2025 bei den American College of Cardiology Scientific Sessions präsentiert.
- Both pivotal trials met primary endpoints with statistically significant blood pressure reductions
- Launch-HTN showed sustained benefit through week 12 with potential further reduction
- Favorable safety profile with low rates of serious adverse events
- Large addressable market of 15-20 million patients in the US
- Results support potential regulatory approval and commercial value
- Higher hyperkalemia rates in Advance-HTN trial (up to 7.4%) compared to Launch-HTN
- Some patients required dose escalation to 100mg for optimal effect
Insights
Mineralys Therapeutics' pivotal trial results for lorundrostat represent a significant clinical achievement in hypertension management. The drug demonstrated impressive efficacy with the 50mg dose achieving a 9.1 mmHg placebo-adjusted systolic blood pressure reduction at 6 weeks and 11.7 mmHg reduction at 12 weeks in Launch-HTN. The Advance-HTN trial confirmed these findings with a 7.9 mmHg placebo-adjusted reduction by 24-hour ambulatory blood pressure monitoring.
These reductions are clinically meaningful in cardiovascular risk management - a sustained 10 mmHg systolic reduction typically translates to approximately 20% lower risk of major cardiovascular events. The magnitude of effect positions lorundrostat favorably among antihypertensive therapies, particularly for the resistant hypertension population where additional options are desperately needed.
The safety profile appears favorable with serious adverse events comparable to placebo. Hyperkalemia rates varied between trials (1.1-1.5% in Launch-HTN vs 5.3-7.4% in Advance-HTN), which warrants attention but remains manageable with monitoring. By targeting aldosterone synthesis - a hormone pathway implicated in resistant hypertension - lorundrostat addresses a distinct mechanism complementary to existing therapies.
With approximately 15-20 million Americans having uncontrolled hypertension despite multiple medications, lorundrostat fills a important therapeutic gap. The consistency of results across three clinical trials creates a compelling regulatory package that substantially derisks the development program.
These pivotal trial results transform Mineralys Therapeutics' commercial outlook. Successfully hitting primary endpoints in both studies establishes lorundrostat as a potential first-in-class aldosterone synthase inhibitor for resistant hypertension - a condition with significant unmet need and commercial opportunity.
The addressable market of 15-20 million patients in the US alone represents substantial revenue potential. Resistant hypertension patients typically fail multiple generic medications, making this a premium-priced segment where payers recognize the economic burden of uncontrolled cardiovascular disease.
Lorundrostat's clinical profile offers several commercial advantages: once-daily oral dosing, placebo-like tolerability, and efficacy demonstrated as add-on to existing regimens. This positions it ideally for adoption in real-world clinical settings where physicians seek effective add-on therapies for difficult-to-treat patients.
The robust data package now includes three successful trials, meaningfully derisking regulatory approval prospects. While specific timeline for filing wasn't disclosed, the comprehensive dataset suggests a straightforward path to submission.
For Mineralys as a single-asset company with ~$525M market cap, this positive data fundamentally enhances corporate valuation by reducing development risk for its lead program. The company has now delivered on a critical milestone that validates its development strategy and enhances partnership potential as they advance toward commercialization in a valuable cardiovascular market segment.
– Launch-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at week 6 –
– Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure, and an 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at end of treatment, week 12 –
– Advance-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a highly statistically significant 7.9 mmHg placebo-adjusted reduction assessed by 24hr ABPM at end of treatment, week 12 –
– Lorundrostat demonstrated a favorable safety and tolerability profile in both pivotal trials –
– Full results from Advance-HTN to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions –
– Conference call today at 8:00 a.m. ET –
RADNOR, Pa., March 10, 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 positive topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). Both trials successfully achieved statistical significance and were clinically meaningful in their pre-specified primary efficacy endpoints and demonstrated a favorable safety and tolerability profile.
“The positive results and clinically meaningful reduction in blood pressure observed in the Launch-HTN and Advance-HTN trials show us that lorundrostat has the potential to be a transformative new therapy for the approximately 15 to 20 million patients with uncontrolled hypertension in the United States,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We have now completed three successful clinical trials demonstrating the efficacy, safety and tolerability of lorundrostat and the importance of targeting dysregulated aldosterone. We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value. We appreciate the commitment and hard work of the clinical investigators, site staff, the Mineralys and Cleveland Clinic research teams, and especially the trial subjects who volunteered to participate in our program.”
Efficacy Results
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.
| Launch-HTN Phase 3 Trial (automated office systolic blood pressure measure, n=1,083) | ||||
| Week 6 (50 mg pooled) | Week 12 | |||
| Absolute Reduction | Placebo-Adjusted Reduction | Absolute Reduction | Placebo-Adjusted Reduction | |
| 50 mg | -16.9 mmHg | -9.1 mmHg (p<0.0001)* | -19.0 mmHg | -11.7 mmHg (p<0.0001) |
| 50 to100 mg | -15.7 mmHg | -8.4 mmHg (p=0.0016) | ||
| * Primary endpoint | ||||
- The change in blood pressure in response to lorundrostat in subjects using two background antihypertensives (uncontrolled) or three to five (resistant) were similar, and both were statistically significantly different from the response in those taking placebo.
The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 pivotal trial that evaluated the efficacy and safety of lorundrostat for the treatment of confirmed uHTN or rHTN, when used as add-on therapy to an optimized background treatment of two or three antihypertensive medications in adult subjects. The trial met its primary endpoint, with placebo-adjusted reduction from baseline in systolic blood pressure assessed with 24-hour average blood pressure measurement at week 12 of -7.9 mmHg in subjects treated with 50 mg of lorundrostat. Other prespecified outcome measures, including measures of efficacy in the dose-escalation cohort, safety and tolerability, were consistent with those observed in the Launch-HTN trial.
Additional details regarding the results from Advance-HTN are embargoed until presentation on March 29, 2025, at the American College of Cardiology Scientific Sessions.
Safety and Tolerability Results
We believe clinical safety findings, including hypotension, serum potassium, eGFR and serum cortisol, from both pivotal trials, support a favorable benefit-risk profile.
- In the Launch-HTN trial there were 12 subjects (
2.2% ) and two subjects (0.7% ) with treatment-emergent serious adverse events (SAEs) in the 50 mg and 50 mg with optional dose escalation to 100 mg arms, respectively, compared with eight subjects (3.0% ) in the placebo arm. There was only one subject (0.1% ) in the trial with treatment-related SAEs that occurred in the 50 mg arm. - The incidence of hyperkalemia (serum potassium above 6.0 mmol/L) in the 50 mg and 50mg to 100mg arms, respectively, was
1.1% and1.5% in the Launch-HTN trial and5.3% and7.4% in the Advance-HTN trial.
“The Launch-HTN study evaluating novel drug lorundrostat is one of the largest blood pressure studies in recent times and demonstrates its benefit in lowering blood pressure and its safety in a diverse group of patients whose hypertension is not well controlled,” stated Manish Saxena MBBS, Hypertension Specialist from Barts Health NHS Trust. “Uncontrolled and resistant hypertension remains a global health concern as it continues to be the leading cause of cardiovascular deaths, heart attacks and strokes. Given today’s announcement, lorundrostat could be a good treatment option for millions of patients with high blood pressure."
Mineralys plans to provide additional data from these two pivotal trials at upcoming medical conferences and in peer-reviewed publications.
The ongoing Transform-HTN open-label extension trial allows subjects to continue to receive lorundrostat and generate additional safety and efficacy data.
Conference Call
The Company’s management team will host a conference call today, March 10, 2025, at 8:00 a.m. ET. To access the call, please dial 1-877-704-4453 in the U.S. or 1-201-389-0920 outside the U.S. A live webcast of the conference call may be found here. A replay of the call will be available on the “News & Events” page in the Investor Relations section of the Mineralys Therapeutics website (click here).
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 estimated annual economic burden of about
Less than 50 percent 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 percent of all hypertensive patients.
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN and 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
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 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 subjects 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 automated office blood pressure 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 subjects. Subjects who meet screening criteria had their existing hypertension medications discontinued and start 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 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 https://mineralystx.com. 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, 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 Relations
investorrelations@mineralystx.com
Media Relations
Tom Weible
Elixir Health Public Relations
Phone: (1) 515-707-9678
Email: tweible@elixirhealthpr.com
FAQ
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