Aldosterone

Mineralys Therapeutics Announces Expansion of Planned Phase 2 Trial of Lorundrostat Alone and in Combination with SGLT2 Inhibitor to Treat Patients with Chronic Kidney Disease (CKD)

Retrieved on: 
Monday, July 17, 2023
Enzyme inhibitor, ARB, Optimism, Chronic kidney disease, Terminal, EGFR, Part, SGLT2, Alveolar soft part sarcoma, ASI, Hypertension, Proteinuria, Aldosterone, Patient, FAHA, Risk, ACE, Therapy, CKD, Safety, Pharmaceutical industry

RADNOR, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced details of an expanded two-part Phase 2 clinical trial for lorundrostat as a potential therapy to treat patients with Stage 2 to 4 chronic kidney disease (CKD), which is expected to start enrolling patients in the second half of 2023.

Key Points: 
  • “We are excited to move ahead with this trial to evaluate lorundrostat as a treatment for CKD.
  • This trial builds upon the amelioration of aldosterone-mediated uncontrolled hypertension we observed in our Target-HTN trial of lorundrostat.
  • “There is a growing consensus for the use of an SGLT2 inhibitor as a component of CKD treatment.
  • Subjects will receive either once daily combination treatment of lorundrostat 50 mg plus dapagliflozin 10 mg or placebo for 12 weeks.

EQS-News: Eckert & Ziegler: Recognized Australian Endocrine & Hypertension Center Joins International Groups with a Clinical Trial of PentixaPharm’s Primary Aldosteronism Lead Candidate

Retrieved on: 
Tuesday, May 9, 2023
Blood pressure, Primary aldosteronism, CT, CXCR4, Heart failure, Gland, Hypertension, Stroke, APA, TecDAX, BAH, Nuclear medicine, File association, Trial of the century, Investigator, Aldosterone, Patient, Risk, Hyperplasia, Adenoma, Chief medical informatics officer, Surgeon, Hudson Institute, ISIN, Principal, Monash, AVS, Eckert, Pharmaceutical industry, Medical imaging, Gallium

Primary Aldosteronism (PA) refers to the hypersecretion of aldosterone, a hormone that increases blood pressure and consequently leads to high vascular morbidity including stroke and heart failure.

Key Points: 
  • Primary Aldosteronism (PA) refers to the hypersecretion of aldosterone, a hormone that increases blood pressure and consequently leads to high vascular morbidity including stroke and heart failure.
  • It would most likely have a large impact on clinical practice and enable a large number of hypertension patients to be cured.
  • The study in Australia is in line with clinical activities in Europe and in the USA, which are supported by PentixaPharm.
  • [68Ga]Ga-PentixaFor is being developed by Eckert & Ziegler's subsidiary PentixaPharm GmbH also as a superiorly sensitive diagnostic for a portfolio of hematooncological malignancies.

Mineralys Therapeutics Announces First Patient Dosed in the ADVANCE-HTN Pivotal Trial of Lorundrostat for the Treatment of Uncontrolled and Resistant Hypertension

Retrieved on: 
Tuesday, May 2, 2023
Obesity, Chronic kidney disease, Hypertension, Aldosterone, Patient, Disease, Therapy, CKD, Safety, Pharmaceutical industry

RADNOR, Pa., May 02, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced the first patient dosed in the ADVANCE-HTN pivotal trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN) when used as an add-on therapy to standardized background treatment of two or three antihypertensive medications. The topline data from this trial are expected in the first half of 2024.

Key Points: 
  • “The ADVANCE-HTN trial marks an important milestone for Mineralys as we initiate our pivotal program for lorundrostat.
  • Over half of all treated hypertension patients fail to achieve their goal blood pressure and many continue to experience increased cardiorenal morbidity and mortality risk.
  • Abnormal aldosterone production is considered a key driver in uncontrolled and resistant hypertension,” stated Jon Congleton, Chief Executive Officer of Mineralys.
  • Uncontrolled and resistant hypertension represent a significant unmet need within the approximately 115 million patients in the U.S. who have high blood pressure.

EQS-News: PAION IS HOSTING A SPONSORED ANGIOTENSIN II SYMPOSIUM AT ISICEM IN BRUSSELS

Retrieved on: 
Thursday, March 16, 2023
Hypotension, Learning, Mortality, Acute kidney injury, Blood pressure, International Symposium on Endovascular Therapy, Frankfurt Stock Exchange, Phosphorylation, ISIN, Patient, Angiotensin, III, Shock, Vasoconstriction, Septic, European Commission, FDA, Catecholamine, Septic shock, Distributive shock, Emergency medicine, Intensive care medicine, II, Aldosterone, Anesthesia, Civil service commission, Pharmaceutical industry

One abstract about angiotensin II has been accepted for a presentation.

Key Points: 
  • One abstract about angiotensin II has been accepted for a presentation.
  • In addition, PAION has organised a Sponsored Symposium.
  • Poster number P219
    This post hoc analysis helps to understand which group of patients might be further studied to determine benefits from treatment with angiotensin II.
  • Angiotensin II mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure.

Mineralys Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 15, 2023
Target, Research, Conference, Therapy, IPO, Blood pressure, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Congress, Research and development, Administration, Patient, American College, Hypertension, BMI, Chronic kidney disease, FDA, Mitsubishi Tanabe Pharma, G&A, Public, Safety, ID, Body mass index, Conference call, Food, Pharmacokinetics, Aldosterone, R, Pharmaceutical industry, Cryptocurrency

RADNOR, Pa., March 15, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2022, and provided a corporate update.

Key Points: 
  • ET –
    RADNOR, Pa., March 15, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2022, and provided a corporate update.
  • “Uncontrolled and resistant hypertension continue to impact individual patient’s lives and the healthcare system at large.
  • G&A expenses were $2.2 million for the three months ended December 31, 2022, compared to $0.5 million for the three months ended December 31, 2021.
  • A replay of the call will be available on the “ News & Events ” page in the Investor Relations section of the Mineralys Therapeutics website.

Mineralys Therapeutics Presents Positive Lorundrostat Results from the Phase 2 Target-HTN Trial at ACC.23/WCC

Retrieved on: 
Saturday, March 4, 2023
BID, Blood pressure, Hyponatremia, Mortality, Plasma protein binding, Cleveland Clinic, Incidence, Prevalence, Obesity, Hypertension, Thought, BP, Therapy, Patient, Risk, Urinary tract infection, Congress, Target, Male, Poster, American College, Female, BMI, Aldosterone, Disease, RAAS, Safety, Glomerular filtration rate, Pharmaceutical industry

RADNOR, Pa., March 04, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced positive data from the Target-HTN Phase 2 study that demonstrated clinically meaningful blood pressure reduction with once-daily dosing of lorundrostat at the American College of Cardiology’s 72nd Annual Scientific Session together with the World Congress of Cardiology (ACC.23/WCC) going on now in New Orleans, LA. In a pre-specified analysis, hypertensive subjects with a BMI ≥30 kg/m2, demonstrated a statistically significant reduction of placebo-adjusted change in systolic blood pressure (BP) of 16.7 mmHg (p=0.002) with 50mg QD and a reduction of 12.3 mmHg (p=0.030) with 100 mg QD in Part 1 of the study.

Key Points: 
  • “We continue to be excited by the compelling data from our Target-HTN trial.
  • As rates of hypertension and obesity continue to evolve, so must our approach to treatment,” said David Rodman, M.D., Chief Medical Officer of Mineralys.
  • During ACC.23/WCC, the Company will also present Phase 1 data for lorundrostat that is included in a poster titled, “First-In-Human Study of lorundrostat, a Potent and Highly Selective Aldosterone Synthase Inhibitor”.
  • The poster will be made available on the Company’s website here on March 5, 2023.

Successful IPO of HBM portfolio company Mineralys Therapeutics

Retrieved on: 
Wednesday, February 22, 2023
ASI, HBM, CHF, Therapy, USD, IPO, Hypertension, Patient, NAV, Aldosterone, Pharmaceutical industry

Mineralys Therapeutics (Nasdaq: MLYS), a previously private company in the portfolio of HBM Healthcare Investments, successfully completed its IPO last Friday.

Key Points: 
  • Mineralys Therapeutics (Nasdaq: MLYS), a previously private company in the portfolio of HBM Healthcare Investments, successfully completed its IPO last Friday.
  • The company placed 12 million new shares at a price of USD 16.00 per share, raising USD 192 million in new capital.
  • HBM Healthcare Investments has invested a total of USD 19 million in the company in two private financing rounds since February 2021.
  • Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone.

EQS-News: Andera Partners Portfolio Company Mineralys Therapeutics Successfully Completes Upsized $192 Million Nasdaq IPO

Retrieved on: 
Wednesday, February 22, 2023
Therapy, Investment, Andera-ye Olya, Patient, IPO, Hypertension, Growth, Aldosterone, Security (finance), Pharmaceutical industry

PARIS, FRANCE – FEBRUARY 14, 2023 – Andera Partners, a leading European private equity player, through its practice Andera Life Sciences, focused on investments in companies developing breakthrough therapeutics and medical technologies, announces that its portfolio company Mineralys Therapeutics completed last Friday an oversubscribed and upsized $192 million initial public offering (IPO) on the Nasdaq Global Select Market at $16.00 per share.

Key Points: 
  • PARIS, FRANCE – FEBRUARY 14, 2023 – Andera Partners, a leading European private equity player, through its practice Andera Life Sciences, focused on investments in companies developing breakthrough therapeutics and medical technologies, announces that its portfolio company Mineralys Therapeutics completed last Friday an oversubscribed and upsized $192 million initial public offering (IPO) on the Nasdaq Global Select Market at $16.00 per share.
  • Andera co-led the company’s $118 million Series B financing in June 2022 and re-invested into the oversubscribed IPO financing.
  • The IPO financing will support the company to advance its pivotal program in uncontrolled hypertension in the United States.
  • Through this IPO on Nasdaq, Andera Partners supported again the growth of its portfolio companies through public market financing.

Idorsia submits a New Drug Application to the US FDA for aprocitentan for the treatment of patients with difficult-to-control hypertension

Retrieved on: 
Tuesday, December 20, 2022
ETA, Fibrosis, IDIA, ETB, Randomized controlled trial, Moyamoya disease, Food, End organ damage, MD, American Heart Association, BP, Endothelin 1, Death, NDA, Risk, Johnson & Johnson, Patient, Science, Janssen Biotech, Aldosterone, Vascular remodelling in the embryo, US Foods, Safety, Heart failure, FDA, Hypertension, Janssen Pharmaceuticals, Obesity, Chronic kidney disease, Lancet, AHA, Blood pressure, Diabetes, Endothelial dysfunction, Hypertrophy, Kidney, Pharmaceutical industry

In the Phase 3 registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to combination background antihypertensive therapy in patients with resistant hypertension.

Key Points: 
  • In the Phase 3 registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to combination background antihypertensive therapy in patients with resistant hypertension.
  • In PRECISION, aprocitentan was generally well tolerated with no major safety concerns.
  • By targeting a currently unopposed pathophysiologic pathway, aprocitentan represents a potential novel, effective, and well-tolerated treatment for difficult-to-control hypertension.
  • Idorsia is developing aprocitentan together with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

CinCor Pharma Announces Topline Data for Phase 2 HALO Trial Evaluating Selective Aldosterone Synthase Inhibitor Baxdrostat in Uncontrolled Hypertension

Retrieved on: 
Monday, November 28, 2022
SAE, COVID-19, Hypertension, American Heart Association, Stroke, Cardiology, Kidney disease, American College of Cardiology, American College, Risk, Degenerative disease, Safety, Plasma protein binding, Patient, HALO, Aldosterone, Annual report, Primary aldosteronism, FDA, Death, Security (finance), SBP, ID, CKD, Clinical trial, Pharmaceutical industry, Collection

The primary endpoint of the trial was the change in SBP after eight weeks of treatment.

Key Points: 
  • The primary endpoint of the trial was the change in SBP after eight weeks of treatment.
  • CinCor management will hold a conference call and live webcast today at 8:00 AM Eastern Time to provide an update on the Phase 2 HALO trial.
  • Its lead asset, baxdrostat, a highly selective, oral small molecule inhibitor of aldosterone synthase, is in clinical development for the treatment of hypertension and primary aldosteronism.
  • Though often asymptomatic, hypertension significantly increases the risk of heart disease, stroke, and kidney disease, amongst other diseases.