Mineralys Therapeutics Completes Target Enrollment in Pivotal Advance-HTN Trial of Lorundrostat for the Treatment of Hypertension
Mineralys Therapeutics (Nasdaq: MLYS) has achieved the target enrollment of 261 subjects in its pivotal Advance-HTN trial, evaluating lorundrostat for uncontrolled or resistant hypertension. The trial tests lorundrostat as an add-on therapy to standardized background treatment of two or three antihypertensive medications. Topline data is expected in Q1 2025.
The Advance-HTN trial is a randomized, double-blind, placebo-controlled Phase 2 study. Subjects are treated for twelve weeks in three cohorts: lorundrostat 50 mg QD, lorundrostat 50 mg QD with option to titrate to 100 mg QD at week four, or placebo.
Mineralys will host a virtual KOL event for investors on October 30, 2024, discussing the unmet need in hypertension and reviewing the ongoing pivotal clinical program for lorundrostat.
Mineralys Therapeutics (Nasdaq: MLYS) ha raggiunto l'obiettivo di arruolare 261 soggetti nel suo trial fondamentale Advance-HTN, che valuta lorundrostat per l'ipertensione non controllata o resistente. Lo studio verifica lorundrostat come terapia aggiuntiva al trattamento standard di due o tre farmaci antipertensivi. I dati preliminari sono attesi nel primo trimestre del 2025.
Il trial Advance-HTN è uno studio di fase 2, randomizzato, in doppio cieco e controllato con placebo. I soggetti sono trattati per dodici settimane in tre coorti: lorundrostat 50 mg QD, lorundrostat 50 mg QD con opzione di titolazione a 100 mg QD alla settimana quattro, oppure placebo.
Mineralys ospiterà un evento KOL virtuale per investitori il 30 ottobre 2024, discutendo del bisogno non soddisfatto nell'ipertensione e rivedendo il programma clinico fondamentale in corso per lorundrostat.
Mineralys Therapeutics (Nasdaq: MLYS) ha logrado el objetivo de inscribir a 261 sujetos en su ensayo pivotal Advance-HTN, que evalúa lorundrostat para la hipertensión no controlada o resistente. El ensayo prueba lorundrostat como terapia complementaria al tratamiento estándar de dos o tres medicamentos antihipertensivos. Se esperan datos preliminares en el primer trimestre de 2025.
El ensayo Advance-HTN es un estudio de fase 2, aleatorizado, doble ciego y controlado con placebo. Los sujetos reciben tratamiento durante doce semanas en tres cohortes: lorundrostat 50 mg QD, lorundrostat 50 mg QD con opción de aumentar a 100 mg QD en la semana cuatro, o placebo.
Mineralys organizará un evento KOL virtual para inversores el 30 de octubre de 2024, discutiendo la necesidad no satisfecha en hipertensión y revisando el programa clínico pivotal en curso para lorundrostat.
미네랄리스 테라퓨틱스(Minéralys Therapeutics)(Nasdaq: MLYS)는 261명의 피험자를 목표로 한 등록을 달성했습니다. 이 주요 임상시험인 Advance-HTN은 통제되지 않거나 저항성 고혈압에 대한 로룬드로스탯을 평가합니다. 이 시험은 로룬드로스탯을 두 가지 또는 세 가지 고혈압 약물의 표준 배경 치료에 추가 요법으로 시험합니다. 최종 데이터는 2025년 1분기에 예상됩니다.
Advance-HTN 시험은 무작위, 이중 맹검, 위약 대조의 2상 연구입니다. 피험자들은 12주 동안 세 그룹으로 치료를 받습니다: 로룬드로스탯 50mg QD, 로룬드로스탯 50mg QD에서 4주차에 100mg QD로 증량할 옵션이 있는 그룹, 또는 위약 그룹입니다.
미네랄리스는 2024년 10월 30일 투자자를 위한 가상 KOL 이벤트를 개최할 예정입니다, 이는 고혈압의 충족되지 않은 필요성에 대해 논의하고 로룬드로스탯에 대한 진행 중인 주요 임상 프로그램을 검토할 것입니다.
Mineralys Therapeutics (Nasdaq: MLYS) a atteint l'objectif d'inscrire 261 sujets dans son essai clinique pivotal Advance-HTN, qui évalue le lorundrostat pour traiter l'hypertension incontrôlée ou résistante. L'essai teste le lorundrostat en tant que thérapie ajoutée à un traitement standard de deux ou trois médicaments antihypertenseurs. Les données préliminaires sont attendues au premier trimestre 2025.
L'essai Advance-HTN est une étude de phase 2, randomisée, en double aveugle et contrôlée par placebo. Les sujets sont traités pendant douze semaines dans trois groupes : lorundrostat 50 mg QD, lorundrostat 50 mg QD avec possibilité de titration à 100 mg QD à la quatrième semaine, ou placebo.
Mineralys organisera un événement KOL virtuel pour les investisseurs le 30 octobre 2024, discutant du besoin non satisfait en matière d'hypertension et examinant le programme clinique pivot en cours pour le lorundrostat.
Mineralys Therapeutics (Nasdaq: MLYS) hat das Ziel von 261 Probanden erreicht in seiner wegweisenden Advance-HTN-Studie, die Lorundrostat bei unkontrollierter oder resistenter Hypertonie bewertet. Die Studie prüft Lorundrostat als Zusatztherapie zu einer standardisierten Grundbehandlung mit zwei oder drei blutdrucksenkenden Medikamenten. Die ersten Ergebnisse werden im ersten Quartal 2025 erwartet.
Die Advance-HTN-Studie ist eine randomisierte, doppelblinde, placebo-kontrollierte Phase-2-Studie. Die Probanden werden zwölf Wochen in drei Gruppen behandelt: Lorundrostat 50 mg QD, Lorundrostat 50 mg QD mit der Option, in der vierten Woche auf 100 mg QD zu titrieren, oder Placebo.
Mineralys wird am 30. Oktober 2024 eine virtuelle KOL-Veranstaltung für Investoren ausrichten, in der der unerfüllte Bedarf bei Hypertonie und das laufende wesentliche klinische Programm für Lorundrostat diskutiert werden.
- Achieved target enrollment of 261 subjects in pivotal Advance-HTN trial
- On track to announce topline data in Q1 2025
- Potential to provide meaningful improvement in cardiovascular risk for hypertension patients
- None.
Insights
The completion of target enrollment in the pivotal Advance-HTN trial for lorundrostat is a significant milestone for Mineralys Therapeutics. This Phase 2 study, evaluating lorundrostat as an add-on therapy for uncontrolled or resistant hypertension, has reached its goal of 261 subjects. The trial's design, using a standardized background treatment and allowing for dose titration, is robust and clinically relevant.
Key points to consider:
- Topline data expected in Q1 2025, which could be a major catalyst for the company
- Focus on uncontrolled and resistant hypertension, addressing a significant unmet medical need
- Potential to improve cardiovascular risk management in a difficult-to-treat population
The upcoming KOL event on October 30th may provide valuable insights into the clinical landscape and lorundrostat's potential market positioning. Investors should closely monitor the trial's progress and upcoming data readouts, as positive results could significantly impact Mineralys' market value and future prospects in the cardiovascular disease space.
This clinical trial milestone is a positive development for Mineralys Therapeutics (NASDAQ: MLYS), a small-cap biopharmaceutical company with a market capitalization of
Key financial implications:
- Reduced enrollment risk, potentially improving investor confidence
- On track for Q1 2025 topline data, which could be a significant value inflection point
- Potential to address a large market, as hypertension affects millions globally
However, investors should note that as a clinical-stage company, Mineralys likely has no current revenue and is burning cash to fund R&D. The success of lorundrostat is critical for the company's valuation. While this news is positive, the true value impact will depend on the trial's results in 2025. Investors should carefully consider the risk-reward profile, as clinical-stage biotech stocks can be volatile, especially around key data readouts.
– On track to announce topline data in Q1 2025 –
– Virtual KOL event scheduled on October 30th to discuss the unmet need in hypertension, as well as a review of the ongoing pivotal clinical program for lorundrostat in hypertension –
RADNOR, Pa., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other prevalent cardiovascular diseases driven by dysregulated aldosterone, today announced that it has achieved the enrollment target of 261 subjects in the pivotal Advance-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications. Additional subjects currently in the screening or the run-in phase for Advance-HTN may be enrolled over the next several weeks. The Company continues to expect to announce topline data in the first quarter of 2025.
“We are excited to achieve target enrollment in our pivotal Advance-HTN trial. It is our goal to provide meaningful improvement in cardiovascular risk for people struggling to achieve their optimal blood pressure level,” stated David Rodman, MD, Chief Medical Officer of Mineralys Therapeutics. “We are hopeful that lorundrostat will continue to show promise for the treatment of hypertension as observed in our previous trial. We wish to thank the participating trial investigators and subjects for their enthusiasm and commitment to the development program for lorundrostat.”
The Advance-HTN trial (NCT05769608) is a randomized, double-blind, placebo-controlled Phase 2 clinical trial to evaluate 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 will have 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 remain hypertensive despite the standardized regimen are 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.
KOL Event Details
The Company will host a virtual KOL event for investors on Wednesday, October 30, 2024 at 10:00 am ET. To register for the event, click here. This event will provide expert perspectives on the currently available treatment options for uHTN and rHTN, as well as a review of the ongoing pivotal clinical program for lorundrostat.
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
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 25 percent of all hypertensive patients.
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN and CKD. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a
In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in individuals with uHTN, 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 Mineralys
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD 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 cardiorenal conditions affected by dysregulated aldosterone, including hypertension and CKD. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter.
Forward Looking 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 United States Food and Drug Administration (FDA); the Company’s ability to evaluate lorundrostat as a potential treatment for CKD or uHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of patients in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Investor 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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