Aldosterone

BridgeBio Pharma Announces Dosing of First Patient in Phase 1/2 Trial of Investigational Gene Therapy for Congenital Adrenal Hyperplasia (CAH)

Retrieved on: 
Thursday, January 27, 2022
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PALO ALTO, Calif., Jan. 27, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the first patient has been dosed in ADventure, its Phase 1/2 clinical trial of BBP-631, an investigational adeno-associated virus (AAV) 5 gene therapy for the treatment of classic congenital adrenal hyperplasia (CAH). CAH is one of the most prevalent genetic diseases, with more than 75,000 cases estimated in the United States and European Union.

Key Points: 
  • Our investigational gene therapy offers patients a potential single-dose intervention designed to restore their bodys hormone and steroid balance by making their own cortisol and aldosterone, said Eric David, M.D., J.D., CEO at BridgeBio Gene Therapy.
  • This is the second gene therapy trial we have initiated in less than four months, and we are excited to advance this trial and our other gene therapy programs in the hope of improving patients lives.
  • As an endocrinologist, its incredibly exciting to reimagine a new approach to treating this disease, added Adam Shaywitz, M.D., Ph.D., chief medical officer at BridgeBio Gene Therapy.
  • Adrenas Therapeutics, the affiliate company of BridgeBio focused on developing BBP-631 for CAH, is part of BridgeBio Gene Therapys portfolio.

CinCor Pharma Appoints June Lee to Its Board of Directors

Retrieved on: 
Thursday, January 13, 2022
Coronavirus Scientific Advisory Board (Turkey), Board, Primary aldosteronism, American Heart Association, Chemistry, Internal medicine, Patient, UCSF School of Medicine, Aldosterone, Stroke, Biotechnology, Hypertension, Genentech, Johns Hopkins University, Degenerative disease, Population, Adult, NASDAQ, CEO, American College of Cardiology, UCSF, GLOBE, Advisory board, School, Cardiology, CINC, Kidney disease, Infection, Therapy, Company, Lists of diseases, Mike Hopkins (basketball), Risk, Translational research, American College, Collection, Bristol Myers Squibb, UCLA, Death, Director, University, Pharmaceutical industry, Medicine

BOSTON, Jan. 13, 2022 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (NASDAQ: CINC) today announced the appointment of the independent member June Lee, M.D.

Key Points: 
  • BOSTON, Jan. 13, 2022 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (NASDAQ: CINC) today announced the appointment of the independent member June Lee, M.D.
  • Dr. Lee brings decades of leadership experience in the biotechnology and pharmaceutical industry and has served in numerous executive and board roles.
  • We are very pleased to welcome June to the CinCor Board, said James Healy, M.D., Ph.D., Chairman of CinCors Board of Directors.
  • As the Companys clinical programs advance, we are continuing to bolster our organizational expertise in areas of strategic organizational leadership and clinical development.

CinCor Pharma, Inc., Doses First Patient in HALO, a Phase 2 Clinical Trial Evaluating CIN-107, a Selective Aldosterone Synthase Inhibitor, in Patients with Uncontrolled Hypertension and High Plasma Aldosterone

Retrieved on: 
Thursday, December 9, 2021
Death, Risk, Collection, Drug, Blood pressure, Population, GLOBE, Patient, Hypertension, Cardiology, American Heart Association, HALO, Safety, Plasma, Degenerative disease, American College, Diabetes, Aldosterone, High, Kidney disease, Adult, Clinical trial, SBP, Stroke, American College of Cardiology, Primary aldosteronism, Pharmaceutical industry

The HALO trial is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, clinical trial designed to assess the safety and efficacy of CIN-107.

Key Points: 
  • The HALO trial is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, clinical trial designed to assess the safety and efficacy of CIN-107.
  • Two-hundred-fifty patients with systolic blood pressure (SBP) greater than 140 mm Hg, or greater than 130 mm Hg if the patient is diabetic, will be enrolled.
  • All patients will be on one antihypertensive agent and have a plasma aldosterone level greater than 6 or 7 ng/dL depending on which background anti-hypertensive they are taking.
  • Our lead asset, CIN-107, a highly selective, oral small molecule inhibitor of aldosterone synthase, is in clinical development for the treatment of hypertension and primary aldosteronism.

Innovative One-Visit Adrenal Tumor Diagnosis and Treatment Program Begins in Tampa

Retrieved on: 
Wednesday, November 3, 2021
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TAMPA, Fla., Nov. 3, 2021 /PRNewswire/ --The Carling Adrenal Center, a worldwide destination for the surgical treatment of adrenal tumors, becomes the first center to offer adrenal vein sampling and curative surgery in one visit.

Key Points: 
  • TAMPA, Fla., Nov. 3, 2021 /PRNewswire/ --The Carling Adrenal Center, a worldwide destination for the surgical treatment of adrenal tumors, becomes the first center to offer adrenal vein sampling and curative surgery in one visit.
  • The innovative approach combines highly specialized adrenal vein sampling with rapid adrenal hormone lab testing and then consultation with the world's highest volume adrenal surgeon.
  • Dr. Carling moved his world-renowned adrenal surgery program from Yale University to Tampa, Florida in early 2020 to start the Carling Adrenal Center .
  • About the Carling Adrenal Center:Founded by Dr.Tobias Carling, one of the world's leading experts in adrenal gland surgery, the Carling Adrenal Center is a worldwide destination for the surgical treatment of adrenal tumors.

CinCor Pharma Appoints Terry Coelho as Executive Vice President, Chief Financial Officer and Chief Business Development Officer

Retrieved on: 
Thursday, October 28, 2021
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CINCINNATI, Oct. 28, 2021 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (CinCor) today announced the appointment of Terry Coelho as Executive Vice President, Chief Financial Officer and Chief Business Development Officer (EVP, CFO and CBDO).

Key Points: 
  • CINCINNATI, Oct. 28, 2021 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (CinCor) today announced the appointment of Terry Coelho as Executive Vice President, Chief Financial Officer and Chief Business Development Officer (EVP, CFO and CBDO).
  • Terry gained broad financial and operational leadership experience at several high-profile and start-up companies, including in the biopharmaceutical sector, said Marc de Garidel, Chief Executive Officer of CinCor.
  • Our entire management team and the Board are very excited to welcome Terry to CinCor.
  • Prior to joining BioDelivery Services, Ms. Coelho served as the Chief Financial Officer of Balchem Corp., a specialty chemicals manufacturer for the human and animal health and nutrition markets.

CinCor Pharma Appoints Mason Freeman, M.D., as Executive VP, Clinical Development

Retrieved on: 
Tuesday, October 19, 2021
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CINCINNATI, Oct. 19, 2021 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (CinCor) today announced the appointment of Mason W. Freeman, M.D., as Executive Vice President, Clinical Development responsible for leading all clinical development at CinCor.

Key Points: 
  • CINCINNATI, Oct. 19, 2021 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (CinCor) today announced the appointment of Mason W. Freeman, M.D., as Executive Vice President, Clinical Development responsible for leading all clinical development at CinCor.
  • Mason will be guiding the clinical development programs for CIN-107 for multiple potential indications, including hypertension, said Marc de Garidel, chief executive officer of CinCor.
  • I look forward to working with the CinCor team and their medical collaborators to improve healthcare outcomes for these patients.
  • Our lead asset, CIN-107, a highly selective, oral small molecule inhibitor of aldosterone synthase inhibitor, is in clinical development for the treatment of hypertension and primary aldosteronism.

CMP Pharma, Inc. Announces Unit Dose Packaging for CaroSpir®, The First and Only FDA-Approved Spironolactone Oral Suspension

Retrieved on: 
Monday, October 18, 2021
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FARMVILLE, N.C., Oct. 18, 2021 /PRNewswire/ --CMP Pharma today announced that CaroSpir (Spironolactone Oral Suspension, 25 mg/5 mL), the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone, is now available in a unit dose cup.

Key Points: 
  • FARMVILLE, N.C., Oct. 18, 2021 /PRNewswire/ --CMP Pharma today announced that CaroSpir (Spironolactone Oral Suspension, 25 mg/5 mL), the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic spironolactone, is now available in a unit dose cup.
  • The new unit dose package makes administering CaroSpir even easier and more convenient for health care providers.
  • The single dose package allows for a more efficient use of nursing resources by eliminating the time needed for compounding or pouring at the bedside.
  • All formulations have 24-month dating and are manufactured and tested at CMP Pharma's FDA-inspected GMP manufacturing facility in Farmville, North Carolina.

CinCor Pharma Raises $143 Million in Series B Financing

Retrieved on: 
Tuesday, October 12, 2021
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CINCINNATI, Oct. 12, 2021 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (“CinCor”) today announced the completion of a $143 million Series B financing. The proceeds from this round will support the continued development of CIN-107, a highly selective, oral small molecule inhibitor of aldosterone synthase product candidate in development for the treatment of hypertension, primary aldosteronism and chronic kidney disease. The new funding will enable completion of the ongoing brigHTN Phase 2 clinical trial in patients with resistant hypertension as well as the ongoing Phase 2 Spark trial in hypertensive individuals with primary aldosteronism; in addition, it will support initiation of two new trials, a Phase 2 clinical trial (HALO) in patients with uncontrolled hypertension and a study of CIN-107’s impact on blood pressure and kidney function in patients with chronic kidney disease (CKD).

Key Points: 
  • Funding will support continued development of CIN-107, a highly selective, oral small molecule inhibitor of aldosterone synthase product candidate, for the treatment of hypertension, primary aldosteronism and chronic kidney disease
    CINCINNATI, Oct. 12, 2021 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (CinCor) today announced the completion of a $143 million Series B financing.
  • CinCor, founded in 2018, is a clinical-stage biopharmaceutical company with a mission to bring innovation to the pharmaceutical treatment of cardio-renal diseases.
  • CinCor has raised $193 million to date in two private financings.
  • Though often asymptomatic, hypertension significantly increases the risk of heart disease, stroke and kidney disease, amongst other diseases.

Trevena Announces First Patient Enrolled in NIH-Funded ACTIV-4 Host Tissue Trial of TRV027 for COVID-19

Retrieved on: 
Monday, July 26, 2021
Branches of biology, Medical specialties, Endocrine system, Peptide hormones, Endocrinology, Hypertension, Renal physiology, Renin, Raas, Angiotensin, Aldosterone

I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active treatment arms available for patient randomization.

Key Points: 
  • I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active treatment arms available for patient randomization.
  • The trial, known as ACTIV-4 Host Tissue, is testing four investigational agents that combat dysregulation of the renin-angiotensin-aldosterone system (RAAS) and the immune system caused by a COVID-19 infection.
  • The trial is enrolling approximately 1,600 patients at over 50 sites in the U.S. TRV027 is part of the initial trial launch, and additional study arms will be added to the trial over time.
  • I am very pleased that we have enrolled our first patient in the ACTIV-4 Host Tissue trial, and I look forward to investigating the potential of TRV027 to modulate the RAAS and improve outcomes for patients hospitalized with COVID-19.

BridgeBio Pharma Receives FDA Fast Track Designation for Investigational Gene Therapy for Congenital Adrenal Hyperplasia

Retrieved on: 
Friday, May 14, 2021
Branches of biology, Biology, Life sciences, Enzymes, Metabolism, Gene therapy, Genetic engineering, Fast track, 21-Hydroxylase, Aldosterone

The FDA\xe2\x80\x99s Fast Track designation reinforces the urgency to address the unmet needs of patients with CAH as quickly and safely as possible.

Key Points: 
  • The FDA\xe2\x80\x99s Fast Track designation reinforces the urgency to address the unmet needs of patients with CAH as quickly and safely as possible.
  • We are grateful to have received Fast Track along with other key designations granted by the FDA and the EMA,\xe2\x80\x9d said Eric David, M.D., J.D., CEO at BridgeBio Gene Therapy, which is focused on developing gene therapy treatment options for patients in need.
  • The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol and aldosterone production.
  • The presentation covered three key Investigational New Drug (IND)-enabling studies that informed the anticipated upcoming clinical trial for BBP-631.