MACR

ACELYRIN, INC. Announces Positive Top-line Results from Its Global Phase 2b/3 Clinical Trial of Izokibep in Psoriatic Arthritis

Retrieved on: 
월요일, 3월 11, 2024
MACR, Psoriatic arthritis, 1991 World Sportscar Championship, INC, Doctor of Philosophy, LOS, MD, SLRN, ISR, Rheumatology, Skin, Safety, Joint, Swedish Health Services, Enthesitis, Patient, Medicine, HS, LEI, Phase, IL-17A

LOS ANGELES, March 11, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance. Results from the 160 mg weekly (QW) and every other week (Q2W) arms showed improved magnitude of responses on higher hurdle endpoints such as ACR70, PASI100, and Minimal Disease Activity relative to the Phase 2 80 mg Q2W dose. This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.

Key Points: 
  • (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance.
  • This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.
  • Izokibep was well-tolerated with a favorable safety profile consistent with previous experience and the IL-17A class, without evidence of the safety liabilities observed with targeting IL-17A&F.
  • This reinforces our enthusiasm for developing izokibep as an important potential new medicine for patients.”

AMGEN PRESENTS NEW RESEARCH IN EARLY PSORIATIC ARTHRITIS AT ACR 2023

Retrieved on: 
화요일, 11월 7, 2023
Patient, Rheumatology Research Foundation, Standard of care, Psoriasis, Headache, American College, VAS, Diarrhea, Research, Nausea, REM, MACR, Common, Amgen, University of Washington School of Medicine, Joint, University, AMGN, American College of Rheumatology, Nonsteroidal anti-inflammatory drug, Safety, LDA, Pain, ACR, BSA, Hospital, Body surface area, Disability, Psoriatic arthritis, Pharmaceutical industry, Medical imaging, Rheumatology

THOUSAND OAKS, Calif., Nov. 7, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from the global Phase 4 FOREMOST study evaluating Otezla® (apremilast) in patients with early oligoarticular psoriatic arthritis. FOREMOST is the first placebo-controlled study designed to specifically assess people with oligoarticular psoriatic arthritis with early disease duration of five or fewer years. Results will be presented at the American College of Rheumatology (ACR) Convergence 2023, Nov. 10-15 in San Diego.

Key Points: 
  • Placebo
    THOUSAND OAKS, Calif., Nov. 7, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from the global Phase 4 FOREMOST study evaluating Otezla® (apremilast) in patients with early oligoarticular psoriatic arthritis.
  • FOREMOST is the first placebo-controlled study designed to specifically assess people with oligoarticular psoriatic arthritis with early disease duration of five or fewer years.
  • Results will be presented at the American College of Rheumatology (ACR) Convergence 2023, Nov. 10-15 in San Diego.
  • "These patients experienced a significant reduction in psoriatic disease activity, a crucial finding for those in the early stages of the condition."

Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting

Retrieved on: 
화요일, 11월 7, 2023
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, C-reactive protein, Headache, American College, TAK, MDA, PGA, MD, Research and development, Skin, Inflammation, AM, Ulcerative colitis, Psoriasis Area and Severity Index, Rash, MACR, Lower respiratory tract infection, Lupus, Common, American College of Rheumatology, Body surface area, Safety, Patient, ACR, BSA, Abstract, PASI, TYK2, Pharmaceutical industry, Copper, Takeda, Psoriasis

These data ( Abstract #L12 ) will be presented on Tuesday, November 14 as part of the late-breaking poster session from 9:00 AM - 11:00 AM PT at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, California.

Key Points: 
  • These data ( Abstract #L12 ) will be presented on Tuesday, November 14 as part of the late-breaking poster session from 9:00 AM - 11:00 AM PT at the American College of Rheumatology (ACR) Convergence 2023 in San Diego, California.
  • There was no clinically significant difference in adverse event rates between doses of TAK-279.
  • “We are also advancing the development of TAK-279 in Crohn’s disease, ulcerative colitis and systemic lupus erythematosus and exploring a range of other potential indications.
  • These opportunities are being explored in parallel with the psoriasis and psoriatic arthritis programs.”

Selecta Biosciences Announces Presentation of Data from Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout During Late-Breaking Session at the EULAR 2023 European Congress of Rheumatology

Retrieved on: 
수요일, 5월 31, 2023
Biologics license application, MACR, European Alliance of Associations for Rheumatology, FACP, Immune tolerance, WHO-convened Global Study of Origins of SARS-CoV-2, Disability, Congress, Patient, European, EULAR, Principal, George Washington University, Chronic pain, European Alliance, BLA, Pharmaceutical industry, Palladium, Rheumatology, Medicine

WATERTOWN, Mass., May 31, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today announced the presentation of positive data from the Phase 3 DISSOLVE I and DISSOLVE II double-blind, placebo-controlled studies of SEL-212 in patients with chronic refractory gout. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase). The data were featured during a late-breaking oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2023 European Congress of Rheumatology being held May 31 – June 3 in Milan, Italy.

Key Points: 
  • SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).
  • The data were featured during a late-breaking oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2023 European Congress of Rheumatology being held May 31 – June 3 in Milan, Italy.
  • The response rate in the high dose group was 56% in DISSOLVE I and 46% in DISSOLVE II.
  • A copy of the presentation will be available in the Resources section of Selecta’s website, http://www.selectabio.com/.

Fortress Biotech Reports Record 2022 Financial Results and Recent Corporate Highlights

Retrieved on: 
목요일, 3월 30, 2023
Rosacea, Fortress Biotech, Waldenström macroglobulinemia, Fortification, CD19, MACR, Chronic lymphocytic leukemia, Stanford University, Fred Hutchinson Cancer Research Center, CKPT, Prescription, Chemistry, Dermatology, Acquisition, Patient, Division, Carcinoma, BLA, Disease, CLL, Gout, FACP, Urica, B-cell lymphoma, IGA, Cytokine release syndrome, PDUFA, Growth, PD-1, FDA, Death, Biologics license application, Dotinurad, Safety, CAR, Hyperuricemia, CR, Mustang Bio, Therapy, ORR, Checkpoint, Fuji, Radiation, Follicular lymphoma, Menkes disease, Clinical trial, NDA, WM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Mustang, Food, Pharmaceutical industry, Cryptocurrency, Mastic (plant resin)

Fortress has also established 25 acquisition companies with expert opinion leaders in multiple therapeutic areas over the past year.

Key Points: 
  • Fortress has also established 25 acquisition companies with expert opinion leaders in multiple therapeutic areas over the past year.
  • In June 2022, we announced that the topline results of Checkpoint’s pivotal trial of cosibelimab in metastatic cSCC were presented at the 2022 American Society of Clinical Oncology Annual Meeting.
  • Also in June 2022, we announced positive interim results from Checkpoint’s pivotal trial of cosibelimab in locally advanced cSCC.
  • In July 2022, we announced that David Jin, who has served as Vice President of Corporate Development since May 2020, was also appointed as Chief Financial Officer effective August 16, 2022.

Tripledemic Leaves Consumers Scrambling for Solutions

Retrieved on: 
화요일, 12월 6, 2022
Zinc, Frontiers, Degenerative disease, Vitamin A, Quercetin, Virus, Copper, Pneumonia, MACR, Immune system, Interview, Biotechnology, MD, Tel Aviv University, Head, Patient, FACP, COVID, Betacoronavirus, Cholecalciferol, Medicine, Cell, Flavonoid, RSV, Vitamin D, Risk, Vaccine, Dietary supplement, Pharmaceutical industry, Nutrition, COVID-19, Grapefruit, Selenium

MIAMI, Dec. 6, 2022 /PRNewswire/ -- As an onslaught of Respiratory Synctial Virus (RSV) and cold and flu season creates a perfect storm of illnesses over the next several months, people are wondering what they can do to stay healthy. One Miami-based physician and scientists at Tel Aviv University announced important findings from a study that shows a nutraceutical called DEFENSE can add an extra layer of protection by forming a barrier to stop viruses from entering the cells in the lungs and other areas of the body. The patented preventative respiratory support formula is an important development because it is believed to be one of the only nutraceuticals proven to reduce risk, help alleviate symptoms, and stop viruses from spreading.

Key Points: 
  • "With experts warning of a spike in immune-resistant respiratory illnesses over the next several months, we will see people looking for solutions to stay healthy.
  • Fortunately, we can now say with certainty that DEFENSE is so effective at stopping viruses in their tracks that everyone should have it in their medicine cabinets."
  • Formulated by renowned scientists at Tel Aviv University, DEFENSE has 10 active ingredients, including Zinc, Vitamin A, Vitamin D3, Selenium, Grapefruit, Quercetin, and more.
  • Our unique formulation called DEFENSE is effective because it significantly enhances the performance of zinc, thereby preventing and reducing symptoms."

Data Presented at International Rheumatology Conference Confirms Covid Long Haul Symptoms Linked to Autonomic Nervous System Dysfunction

Retrieved on: 
화요일, 11월 22, 2022
Rheumatology, Publication, Fatigue, MACR, FACP, Dysautonomia, Autonomic nervous system, Research, Degenerative disease, Patient, HRV, Arthralgia, American College, Anxiety, Depression, Frontiers, Athlete, Nutrient, Conference, ANS, Women on Web, Virus, Interview, Medical device, Pharmaceutical industry, Nutrition, COVID

AVENTURA, Fla., Nov. 22, 2022 /PRNewswire/ -- For the first time, data linking COVID long hauler symptoms to autonomic nervous system dysfunction or dysautonomia was recently presented at the annual American College of Rheumatologists Conference on Sunday, November in Philadelphia, Pennsylvania.

Key Points: 
  • Norman B. Gaylis MD, MACR, FACP, presented research and data titled " Autonomic Nervous System Dysfunction: Common Among Patients With Long COVID, an Exploratory Evaluation ."
  • His peers consider his findings game-changing regarding shedding light on how COVID long hauler patients are treated.
  • "No one has ever measured and documented the role of the autonomic nervous system in COVID long haulers before," Gaylis explained.
  • More recently, and after treating many COVID patients, he is dedicated to researching and developing treatments for COVID long hauler patients.

Emerald Health Pharmaceuticals Adds Leading Rheumatologist to Distinguished Systemic Sclerosis Clinical Advisory Board

Retrieved on: 
목요일, 12월 9, 2021
Emerald, University of Washington Department of Global Health, Technology, EHP, Disease, Book, News, CEO, Associate, Microdeletion syndrome, Autoimmunity, Hope, Scleroderma, MBA, Forward-looking statement, GLOBE, ACR, Leadership, Patient, Lung, Disease-modifying antirheumatic drug, Toxic epidermal necrolysis, Orphan, MACR, Fibrosis, Company, Johns Hopkins University, Tissue, Systemic scleroderma, Multiple sclerosis, Skin, Gastrointestinal tract, University, FDA, American College of Rheumatology, Human, SAN, University of Florence, CA, Research, Heart, CB2, Immune system, University of California, San Francisco, American College, Rheumatoid arthritis, CNS, HIF, Clinical trial, Pharmacology, Pharmaceutical industry

Dr. Furst is an international leader in the research and treatment of scleroderma (systemic sclerosis is a severe form of scleroderma).

Key Points: 
  • Dr. Furst is an international leader in the research and treatment of scleroderma (systemic sclerosis is a severe form of scleroderma).
  • He was one of the first to complete placebo-controlled trials in systemic sclerosis and has been a leader in developing multiple clinical trial designs for systemic sclerosis.
  • About Emerald Health Pharmaceuticals Inc.
    Emerald Health Pharmaceuticals is developing novel product candidates for the treatment of CNS, autoimmune, and other diseases.
  • Emerald Health Pharmaceuticals' investigational drug products have not been approved or cleared by the FDA.

U.S. FDA Accepts COUR Pharmaceuticals Investigational New Drug Application (IND) for a Proof-of-Concept Study for the Treatment of Primary Biliary Cholangitis (PBC)

Retrieved on: 
월요일, 10월 4, 2021
MACP, Biotechnology, MACR, Partnership, Immune tolerance, CNP, Inflammation, Liver, Immunodeficiency, Judy, Primary biliary cholangitis, FDA, Patient, Immune system, PBC, Lists of diseases, Takeda, Autoimmunity, Degenerative disease, University, Woman, Disease, Takeda Pharmaceutical Company, Technology, Antigen, Human, IND, Research, University of California, Davis, Safety, Autoimmune disease, Quality of life, Pharmaceutical industry, Vaccine

PBC affects an estimated 130,000 people in the United States, primarily women.

Key Points: 
  • PBC affects an estimated 130,000 people in the United States, primarily women.
  • CNP-104 will be administered via intravenous infusion and harnesses the patient's own immune system to induce tolerance to PDC-E2.
  • "CNP-104 has the potential to halt and reverse PBC by reprogramming T cells to promote immune tolerance through T regulatory cells.
  • COUR Pharmaceuticals is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease.