PROTECT

RedHill Announces First Patient Enrolled in U.S. Government-Supported COVID-19 Study

Retrieved on: 
Wednesday, April 24, 2024
Acute radiation syndrome, Bangladesh Technical Education Board, PROTECT, Safety, SARS-CoV-2, Austerity, IPS, Military medicine, Consortium, United States Army, Patient, HJF, Hospital, COVID-19, Pharmaceutical industry

RALEIGH, N.C. and TEL-AVIV, Israel, April 24, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the first patient has been enrolled in the Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) U.S. government-supported PROTECT multinational platform trial for early COVID-19 outpatient treatment. RHB-107 (upamostat) is the first drug being tested in this platform study. Funded through non-dilutive external sources, including the U.S. Department of Defense, the PROTECT study is expected to be conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by the end of 2024.

Key Points: 
  • RHB-107 (upamostat) is the first drug being tested in this platform study.
  • Phase 2 study," said Gilead Raday, RedHill's Chief Operating Officer and Head of R&D.
  • "RHB-107 is a novel, potentially broad-acting, host-directed antiviral that is expected to act independently of viral spike protein mutations.
  • RHB-107 is the initial drug being evaluated in the early treatment arm of the study.

CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

Retrieved on: 
Wednesday, April 24, 2024
Nephrology, Kidney disease, PROTECT, Proteinuria, European Commission, Kidney failure, Professor, CHMP, Irbesartan, European, EGFR, Senior, Patient, Kidney, CSL Vifor, CSL, Medicine, Committee, Civil service commission, RAAS, Teaching hospital, Clinical trial, Therapy, CMA, SAN, Pharmaceutical industry

ST. GALLEN, Switzerland and SAN DIEGO, April 24, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

Key Points: 
  • The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT clinical trial.
  • "The approval of this innovative treatment is based on data from the only head-to-head phase-III clinical trial in IgAN.
  • CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.

Travere Therapeutics to Present Abstracts on FILSPARI® (sparsentan) in IgA Nephropathy at World Congress of Nephrology and the American Nephrology Nurses Association

Retrieved on: 
Wednesday, April 3, 2024
ART, IgA nephropathy, Congress, Quality of life (healthcare), Patient, SAN, Kidney failure, Immunoglobulin A, RAAS, FSGS, PROTECT, Focal segmental glomerulosclerosis, Abstract, Kidney disease, Therapy, WCN, Proteinuria, ANNA, Communications satellite

SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present nine abstracts in rare kidney disease at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.

Key Points: 
  • SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present nine abstracts in rare kidney disease at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.
  • At WCN, the Company will present subgroup analyses of the Phase 3 PROTECT Study of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) showing the treatment effect across participants with different levels of baseline proteinuria.
  • At ANNA, the Company will present additional insights from the HONUS trial, including health-related quality of life (HRQoL) data and the humanistic burden experienced by patients with IgAN and focal segmental glomerulosclerosis (FSGS).
  • “The data we are presenting at WCN and ANNA reinforce the wealth of evidence supporting FILSPARI’s profile to become an effective foundational treatment replacing RAAS inhibition, with the potential to reduce the lifetime risk of kidney failure for patients with IgAN,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.

New Federal Grant to Help Protect Highway 37 from Flooding

Retrieved on: 
Tuesday, April 9, 2024
Health, Federal Highway Administration, California Department, Transformative use, MTC, Tolay Creek, Transport, Risk, SAN, FHWA, Metropolitan Transit Commission, PROTECT, Water, CTC, Multimedia, Resilience, SMART, Road

SAN FRANCISCO, April 8, 2024 /PRNewswire/ -- The Federal Highway Administration (FHWA) last week approved a $20 million grant to the Metropolitan Transportation Commission to help the Resilient State Route 37 partners — which include MTC, Caltrans, the California State Transportation Agency, the California Natural Resources Agency, the California Department of Fish and Wildlife, the Bay Conservation and Development Commission, the San Francisco Bay Regional Water Quality Control Board, SMART and the county transportation agencies in Marin, Napa, Solano and Sonoma counties — implement improvements to reduce the risk of roadway flooding and inundation along the 10-mile stretch of Highway 37 between Sears Point in Sonoma County and Mare Island in Vallejo.

Key Points: 
  • "The FHWA's support shows the Resilient State Route 37 program is not just a Bay Area priority but a national priority," said MTC Chair and Napa County Supervisor Alfredo Pedroza.
  • "This is another important step toward assembling the funding needed to meet the challenges facing this corridor.
  • FHWA awarded the grant through its Promoting Resilient Operations for Transformative, Efficient and Cost-Saving Transportation (PROTECT) discretionary grant program, which was established by the Bipartisan Infrastructure Law enacted in 2021.
  • Resilience improvements designed to increase Highway 37's ability to withstand winter storms and rising sea levels are scheduled to begin in 2026.

Saranas Reveals Groundbreaking SAFE-MCS Study Results at CRT 2024

Retrieved on: 
Monday, March 11, 2024
Surgery, Medical Devices, Health, Clinical Trials, Cardiology, CRT, Aortic stenosis, Physician, Risk, Early, Patient, Percutaneous coronary intervention, Henry Ford Health, MCS, PROTECT, Morristown Medical Center, Henry Ford, PCI, Bleeding, EVAR, Safety, Structural heart disease, TAVR, FDA

“This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.

Key Points: 
  • “This study is the first of its kind to specifically evaluate bleeding complications in patients undergoing protected PCI, with independently adjudicated results.
  • The Saranas Early Bird Bleed Monitoring System is the first and only FDA-approved device for real-time monitoring of endovascular bleed complications.
  • “We would like to thank the excellent team of physicians and coordinators who contributed to the success of this study,” commented Mike MacKinnon, CEO and President of Saranas.
  • Saranas is dedicated to establishing a new benchmark for bleed detection during and after endovascular procedures, with the goal of improving patient outcomes and decreasing healthcare expenses overall.”

Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

Retrieved on: 
Monday, March 11, 2024
Angiotensin, SAN, European Commission, EMA, Erosion (morphology), Committee, New Drug Application, PROTECT, FDA, Food, Dialysis, Shanda, Hope, Risk, Civil service commission, Therapy, CHMP, CSL Vifor, EGFR, Patient, Immunoglobulin A, Kidney disease, Disease, Kidney, CMA, Proteinuria, Pharmaceutical industry

The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.

Key Points: 
  • The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
  • “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN.
  • “FILSPARI is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis.
  • The FDA has 60 days from the receipt of the application to determine whether to accept it for review.

Mikra PROTECT Immune Support Gummy Now Shipping

Retrieved on: 
Friday, February 23, 2024
Infection, PROTECT, Zinc, Vitamin, Sale, C2, Science, Immune system, Dietary supplement

Introduced by its U.S. biosciences subsidiary Mikra Cellular Sciences Inc. ("Mikra"), these immune support gummies continue Lifeist's commitment to offering natural, science-backed solutions to its valued customers.

Key Points: 
  • Introduced by its U.S. biosciences subsidiary Mikra Cellular Sciences Inc. ("Mikra"), these immune support gummies continue Lifeist's commitment to offering natural, science-backed solutions to its valued customers.
  • "PROTECT is another example of our commitment to introducing science-backed natural solutions to everyday concerns.
  • It combines the antioxidant power of Aronia berries with the immune support of zinc and key vitamins, delivering them all with the on-the-go convenience of a tasty gummy," said Meni Morim, CEO of Lifeist.
  • “Following positive feedback from loyal early adopters of Mikra products, we are pleased to offer PROTECT for retail sale to everyone, now shipping from wearemikra.com."

Cancer Grand Challenges announces five new teams taking on cancer’s toughest challenges

Retrieved on: 
Wednesday, March 6, 2024
Research, Philanthropy, Fund Raising, General Health, Health, Foundation, Other Philanthropy, Science, Oncology, Other Science, Allergy, Massachusetts Institute of Technology, Incidence, Radiation, KITZ, NCI, PROTECT, Interdisciplinarity, Cancer Research UK, Prostate, Geography, National Cancer Institute, Breast, Neoplasm, Autoimmunity, University, KiKa, Death, Antigen, Patient, Factorization of polynomials, Disease, Massachusetts General Hospital, Grand Challenges, Risk, Mortality, Morehouse School of Medicine, Infection, Pharmaceutical industry

Cancer Grand Challenges, a global research funding initiative co-founded by Cancer Research UK and the National Cancer Institute, today announces funding for five new global research teams to take on some of the toughest cancer challenges: cancer inequities, early-onset cancers, solid tumors in children and T-cell receptors.

Key Points: 
  • Cancer Grand Challenges, a global research funding initiative co-founded by Cancer Research UK and the National Cancer Institute, today announces funding for five new global research teams to take on some of the toughest cancer challenges: cancer inequities, early-onset cancers, solid tumors in children and T-cell receptors.
  • These include the Scientific Foundation of the Spanish Association Against Cancer, the Bowelbabe Fund for Cancer Research UK, Institut National Du Cancer, the Dutch Cancer Society, The Mark Foundation for Cancer Research and KiKa (Children Cancer Free Foundation).
  • “Together with our network of visionary partners and research leaders, Cancer Grand Challenges unites the world's brightest minds across boundaries and disciplines and aims to overcome cancer’s toughest problems,” said Dr. David Scott, Director of Cancer Grand Challenges.
  • The Cancer Grand Challenges community has grown to more than 1,200 investigators and collaborators with 16 teams from across the world taking on 13 challenges.

Mikra to Introduce Innovative Immune Support Gummy

Retrieved on: 
Thursday, December 14, 2023
Powder, PROTECT, Science, Vitamin, Vitamin D, Zinc, Water, Mikra, Infection, Immunity, C2, Dietary supplement

“PROTECT is another example of our commitment to bringing science-backed natural solutions to market, marrying the antioxidant power of Aronia berries with the nutritional immune support of key vitamins, in the convenience of a gummy,” said Meni Morim, CEO of Lifeist. “As we head into cold and flu season, PROTECT can provide a defensive boost to immunity -- and unlike pills and powders, can be taken on the go without water. We invite new and loyal customers to sign up at https://bit.ly/mikra-december to receive an invitation for a free trial pack of Protect with their discounted promotional bundle.”

Key Points: 
  • Introduced by its U.S. biosciences subsidiary Mikra Cellular Sciences Inc. ("Mikra"), Protect continues Lifeist's commitment to offering natural, science-backed solutions to its valued customers.
  • An exclusive preview of this innovative product is available for early subscribers who sign up for bundle promotions at https://bit.ly/mikra-december .
  • Protect comes in a tasty gummy format that combines the antioxidant power of Aronia berries1 with the reliable immune support functions of supplemental zinc and vitamin C2, complemented by vitamin D to tackle the shorter days in winter.
  • Its recent addition of two innovative natural products aligns with Mikra's commitment to reaching a wider audience and making their innovative products readily available to enhance wellness journeys.

Travere Therapeutics Announces Late-Breaking Data from Phase 3 Studies of Sparsentan in IgAN and FSGS Published in The Lancet and The NEJM Respectively and Presented at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Friday, November 3, 2023
University of Minnesota Medical School, EGFR, Key finding attacks, Heart Protection Study, Kidney failure, Kidney, University Center, SGLT2, Kidney disease, Society, American Society of Nephrology, Quality of life, Disease, Division, Clinical trial, ASN, Jay Traver, Abstract, The New England Journal of Medicine, Overload, University, Immunoglobulin A, Focal segmental glomerulosclerosis, Therapy, Patient, Death, International Pediatric Nephrology Association, SAN, Proteinuria, Pharmaceutical industry, Dietary supplement, Medical device, IgA nephropathy, Irbesartan, PROTECT, Nephrology, FSGS, Lancet

SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced additional data from two pivotal clinical studies demonstrating sparsentan has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT) and The New England Journal of Medicine (DUPLEX).

Key Points: 
  • Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT ) and The New England Journal of Medicine (DUPLEX) .
  • The absolute overall change in kidney function from baseline to the end of the study for patients treated with FILSPARI was -5.8 mL/min/1.73m2 compared to -9.5 mL/min/1.73m2 with irbesartan.
  • Treatment with FILSPARI demonstrated lower rates of the composite endpoint of 40% decline in eGFR, kidney failure or death compared to irbesartan.
  • Sparsentan showed a consistent and sustained achievement of complete remission of proteinuria in 18.5% of patients on sparsentan vs. 7.5% for irbesartan.