Membrane protein

Tourmaline Bio Initiates Clinical Development of TOUR006 for Cardiovascular Diseases with First Patient Dosed in Phase 2 TRANQUILITY Trial

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木曜日, 5月 16, 2024
Membrane protein, Moyamoya disease, Patient, Pharmacokinetics, TRML, Medical research, Risk, Clinical trial, University, Safety, Stroke, Chronic kidney disease, Senior, MD, Buerger's test, Death, Inflammation, ASCVD, CKD, Medical director, IL-6, Graves' ophthalmopathy, Entrepreneurship, Pharmaceutical industry

NEW YORK, May 16, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced that the first patient has been dosed in its Phase 2 TRANQUILITY trial, marking the initiation of its clinical development program for TOUR006, a long-acting, fully human, anti-IL-6 monoclonal antibody, for the treatment of atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. TRANQUILITY is a randomized, double-blind, placebo-controlled trial enrolling patients with inflammatory risk, manifesting as elevated high-sensitivity C-reactive protein (hs-CRP) at baseline, and chronic kidney disease (CKD).

Key Points: 
  • TRANQUILITY is a randomized, double-blind, placebo-controlled trial enrolling patients with inflammatory risk, manifesting as elevated high-sensitivity C-reactive protein (hs-CRP) at baseline, and chronic kidney disease (CKD).
  • If successful, results from the Phase 2 TRANQUILITY trial are expected to position Tourmaline to be Phase 3-ready in 2025 for ASCVD and other cardiovascular diseases.
  • “We believe TRANQUILITY can showcase TOUR006’s potential as a best-in-class treatment in these indications, offering ease of use and enabling consistent patient adherence, thanks to a potential quarterly dosing schedule.
  • We look forward to sharing topline results from TRANQUILITY in the first half of 2025.”

Molecular Farming Company to Achieve USDA Approval for Plant-Grown Animal Proteins

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月曜日, 4月 22, 2024
FDA, Piggy, RSR, Seed, Risk, Myoglobin, Genetic engineering, USDA, Carbon, Animal, Plant, CFR, Movement, Membrane protein, Genetic distance, APHIS, Biotechnology

Luxembourg, Apr 22, 2024 - (ACN Newswire) - Moolec Science SA (NASDAQ:MLEC)("The company"), a Molecular Farming food-ingredient company, announced today that the Animal and Plant Health Inspection Service ("APHIS") of the U.S. Department of Agriculture ("USDA") has concluded its Regulatory Status Review ("RSR") for Moolec's genetically engineered ("GE") soybean Piggy Sooy(TM).

Key Points: 
  • Luxembourg, Apr 22, 2024 - (ACN Newswire) - Moolec Science SA (NASDAQ:MLEC)("The company"), a Molecular Farming food-ingredient company, announced today that the Animal and Plant Health Inspection Service ("APHIS") of the U.S. Department of Agriculture ("USDA") has concluded its Regulatory Status Review ("RSR") for Moolec's genetically engineered ("GE") soybean Piggy Sooy(TM).
  • The USDA-APHIS RSR determines that Moolec's genetically engineered soybean, accumulating animal meat protein, is unlikely to pose an increased plant pest risk relative to non-engineered soybeans.
  • We achieved an unprecedented milestone in biotechnology with the first-ever USDA-APHIS approval of this kind," stated Gaston Paladini, Moolec Science's CEO & Co-Founder.
  • By adding a well-known animal meat protein (porcine myoglobin) to the standard soybean proteins, the company expects to provide food manufacturers with a unique ingredient that will have a positive carbon and water footprint.

Ventus Therapeutics Announces Results from Phase 1 Clinical Trial of VENT-02, a Novel, Orally Administered, Brain-Penetrant NLRP3 Inhibitor

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水曜日, 4月 17, 2024
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Neurology, Mental Health, Other Science, Research, Science, Clinical Trials, Inflammation, Safety, Risk, Pharmacokinetics, Blood, Membrane protein, Nausea, NLRP3, Collection, Ventus, Half-life, CNS, Therapy, Patient, Headache, Therapeutic index, CSF, Biomarker, Pharmaceutical industry

Ventus Therapeutics , a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today announced results from its Phase 1 clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor.

Key Points: 
  • Ventus Therapeutics , a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today announced results from its Phase 1 clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor.
  • The Phase 1 trial evaluated the pharmacodynamics, pharmacokinetics, safety, and tolerability of VENT-02 across a broad range of single and multiple ascending doses in adult healthy volunteers.
  • The moderate adverse events included headache and nausea and were only observed at a dose multiple times higher than the intended therapeutic doses.
  • Based on the half-life and target coverage observed in the trial, VENT-02 has demonstrated the potential for once-daily dosing.

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

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金曜日, 3月 22, 2024
Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHARM Therapeutics Announces Foundation of Scientific Advisory Board (SAB)

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火曜日, 3月 19, 2024
College, PI3, Data science, Machine, Deep learning, Therapy, Harvard University, Audit trail, Membrane protein, School, Statistics, Biotechnology, ICR, Electrical engineering, Princeton University, 3D, Dartmouth College, Breast cancer, SAB, Applied science, Drug resistance, Royal, Machine learning, Computer science, Drug discovery, Associate, Royal Society, Intelligence, Research, AKT, Cancer, University, Cancer research, DARPA, Howard Hughes Medical Institute, Drug development, Principal, AstraZeneca, Entrepreneurship, The Institute, Biomarker, Columbia University, Faculty, Saint John's College, Stanford University, Chemical engineering, Medicine, Management

LONDON – 19 March 2024 -- CHARM Therapeutics (“CHARM”, “The Company”), a 3D deep-learning research company discovering and developing transformational medicines, today announces the foundation of its Scientific Advisory Board (SAB) to provide expert insight and guidance to the Company on the optimal application of 3D deep learning, protein design and prediction in real world medicine.

Key Points: 
  • LONDON – 19 March 2024 -- CHARM Therapeutics (“CHARM”, “The Company”), a 3D deep-learning research company discovering and developing transformational medicines, today announces the foundation of its Scientific Advisory Board (SAB) to provide expert insight and guidance to the Company on the optimal application of 3D deep learning, protein design and prediction in real world medicine.
  • This pioneering technology enables CHARM to target and develop treatments for previously hard-to-drug targets in cancer and other therapeutic areas.
  • Laksh Aithani, Co-Founder, Chief Executive Officer and Board Member of CHARM Therapeutics, said: “As CHARM advances its 3D deep learning platform in discovery it’s critical to maintain aligned oversight of our priorities and keep abreast of this emerging field.
  • Founding members of CHARM’s SAB:
    David Baker, Ph.D. is a Scientific Co-Founder at CHARM and Chair of the SAB.

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

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金曜日, 3月 22, 2024
FDA, Health, Other Health, Pharmaceutical, Cardiology, Biotechnology, Photograph, Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Webcast, Committee, Spasm, Splenic infarction, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, U.S. FDA, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Rupture, Molina Healthcare, Hypersensitivity, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Multimedia, Uric acid, Dietary supplement

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

InsideTracker Releases New VO2max Product Feature to Support Members’ Improved Healthspan

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火曜日, 1月 23, 2024
Apps, Applications, Technology, Fitness & Nutrition, Health Technology, Software, Biometrics, General Health, Health, Data Management, Artificial Intelligence, Death, Heart, Sleep, Life, Multimedia, Oxygen, Membrane protein, Cell, Disease, VO2 max, Glucose, Habit, Triglyceride, Doctor of Philosophy, Inflammation, Biomarker, Retirement, APOB, HIIT, Exercise, Education, Ageing, Blood, Medical device

InsideTracker , the leading personalized health analysis and data-driven wellness guide that helps people live healthier longer, today announces the addition of a new VO2max development to the product.

Key Points: 
  • InsideTracker , the leading personalized health analysis and data-driven wellness guide that helps people live healthier longer, today announces the addition of a new VO2max development to the product.
  • View the full release here: https://www.businesswire.com/news/home/20240123145598/en/
    InsideTracker Releases New VO2max Product Feature to Support Members’ Improved Healthspan (Graphic: Business Wire)
    VO2max reflects the maximum amount of oxygen used during aerobic exercise and is commonly considered a marker of endurance performance, but is also associated with improved function across other longevity indicators like heart and lung health, inflammation, and susceptibility to early death and disease.
  • “Investing in InsideTracker is like investing in a 401K,” said Dr. Gil Blander, PhD, Founder and Chief Scientific Officer at InsideTracker.
  • In order to take advantage of the product feature, InsideTracker members will be able to connect wearable devices that measure VO2max estimates to their account.

Tourmaline Bio Announces Expected Upcoming Key Milestones for the Clinical Development of TOUR006, a Long-Acting Subcutaneous Inhibitor of IL-6 with Best-in-Class Potential, in Thyroid Eye Disease (TED) and Atherosclerotic Cardiovascular Disease (ASCVD)

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月曜日, 1月 8, 2024
TED, Quality of life, Entrepreneurship, TRML, C-reactive protein, Diplopia, Membrane protein, Moyamoya disease, FDA, Alignment, Inflammation, Injection, Spirited, Half-life, MD, Pharmacokinetics, IL-6, Biomarker, Patient, Safety, Cardiovascular disease, CRP, CAS, Exophthalmos, Pharmaceutical industry

NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, announced today that:

Key Points: 
  • This second pivotal trial will replace the previously planned TED basket trial and does not impact Tourmaline’s expected cash runway through 2026.
  • This trial is targeted to commence in the first half of 2024, with topline data expected in the first half of 2025.
  • Pending success, the results from the Phase 2 trial are expected to position Tourmaline to be ready in 2025 to commence a pivotal Phase 3 trial in cardiovascular disease.
  • To date, TOUR006 has been studied in 448 participants, including patients with autoimmune disorders, across six clinical trials.

Aurinia Submits IND Application to US Food & Drug Administration for AUR 200

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水曜日, 12月 20, 2023
Research, FDA, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Research and development, Food, Immunoglobulin A, Autoimmune disease, BAFF, IND, IgA nephropathy, APRIL, Lupus, Mouse, BCMA, Investigational New Drug, Membrane protein, B-cell activating factor, Rheumatology, American College, Safety, B cell, Pharmaceutical industry

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases.
  • AUR200 is a highly potent and specific Fc-fusion protein containing a modified B cell maturation antigen (BCMA), for enhanced binding to both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).
  • “Our IND submission for AUR200 is an important step forward for Aurinia’s pipeline and our mission to change the trajectory of autoimmune disease.
  • Aurinia acquired AUR200 as part of a strategy to diversify its development pipeline and leverage existing R&D capabilities to advance innovative therapeutic solutions to help people living with autoimmune diseases.

Esperion Presents CLEAR Outcomes Analysis of Inflammation as Predictor of Cardiovascular Risk at American Heart Association Scientific Sessions 2023

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月曜日, 11月 13, 2023
Disease, Esperion Therapeutics, Rash, Abdominal pain, AHA, Membrane protein, Patient, Bempedoic acid, PCSK9, CVD, Anemia, Angioedema, Rupture, Inflammation, Diet, Atherosclerosis, Safety, Incidence, FAHA, Mortality, Tablet, Health, Tendon rupture, Diarrhea, Harvard Medical School, Ezetimibe, Urinary tract infection, Fetus, Hypersensitivity, Arthralgia, Gout, American Heart Association, ESPR, Therapy, Sinusitis, Risk, Spasm, Constipation, MACE, Anaphylaxis, Pain, Moyamoya disease, Back pain, Upper respiratory tract infection, FACC, Flexner Report, CLEAR, Fatigue, Pregnancy, Kidney, Uric acid, MPH, ATP, Bronchitis, Hospital, Dietary supplement, Pharmaceutical industry, Vaccine, Common, Esperies, Brigham, Hyperuricemia, MD, Cholesterol

ANN ARBOR, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from a pre-specified, exploratory analysis of CLEAR Outcomes at the 2023 American Heart Association (AHA) Scientific Sessions. Results were also simultaneously published in Circulation which can be accessed here.

Key Points: 
  • “In the future, it can be anticipated that virtually all atherosclerosis patients will receive aggressive inflammation inhibition along with aggressive cholesterol reduction,” Ridker added.
  • In CLEAR Outcomes, patients who were randomized to bempedoic acid experienced a 21.6% reduction in hsCRP compared to placebo at 6 months.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.