Fibrinolysis

Walden Biosciences Announces Positive Topline Data from Phase 1+ Clinical Study of WAL0921 in Development for Treatment of Kidney Diseases

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월요일, 4월 15, 2024
Receptor (biochemistry), Podocyte, Kidney disease, Safety, Kidney, Pharmacokinetics, Fibrinolysis, Trial of the century, Reduction, Dialysis, Monoclonal antibody, Pharmaceutical industry

CAMBRIDGE, Mass., April 15, 2024 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed clinical development stage company focused on disease-modifying, transformative therapies for the treatment of kidney diseases, today announced the results from the Company’s Phase 1+ clinical study of WAL0921 in healthy subjects. WAL0921 is Walden’s first-in-class, proprietary, humanized monoclonal antibody that binds circulating free soluble urokinase plasminogen activator receptor (suPAR) and its membrane bound form, uPAR, and inhibits their pathological activity, which causes kidney diseases.

Key Points: 
  • WAL0921 is Walden’s first-in-class, proprietary, humanized monoclonal antibody that binds circulating free soluble urokinase plasminogen activator receptor (suPAR) and its membrane bound form, uPAR, and inhibits their pathological activity, which causes kidney diseases.
  • The compromised kidney structure and function ultimately may lead to end-stage kidney disease requiring dialysis.
  • The Phase 1+ clinical study was a single center, placebo-controlled, single ascending dose study of WAL0921 in five cohorts that evaluated its safety, pharmacokinetics, and pharmacodynamics in 40 healthy subjects.
  • Data from the study showed that WAL0921 was safe, well-tolerated, and demonstrated proof-of-biology through a rapid, dose-dependent reduction in free suPAR levels.

NodThera Publishes Preclinical Data Demonstrating Reversal of Obesity and Inflammation with Clinical-stage Brain-penetrant NLRP3 Inflammasome Inhibitors

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월요일, 2월 19, 2024
DOI, PCSK9, Fibrinolysis, Inflammation, Obesity, Cardiovascular disease, Weight loss, NLRP3, Fibrinogen, Astrogliosis, Biomarker, Therapy, Lipid metabolism, Patient, Journal, Experiment, Disease, Phases of clinical research, Mouse, Pharmaceutical industry

The data are published in the Journal of Pharmacology and Experimental Therapeutics in a paper titled ‘Reversal of high fat diet-induced obesity, systemic inflammation and astrogliosis by the NLRP3 inflammasome inhibitors NT-0249 and NT-0796’1.

Key Points: 
  • The data are published in the Journal of Pharmacology and Experimental Therapeutics in a paper titled ‘Reversal of high fat diet-induced obesity, systemic inflammation and astrogliosis by the NLRP3 inflammasome inhibitors NT-0249 and NT-0796’1.
  • The NLRP3 inflammasome is a highly validated anti-inflammatory drug target, and these findings demonstrate that NLRP3 plays a key role in controlling obesity and obesity-associated inflammation through the modulation of hypothalamic gliosis.
  • Both NT-0796 and NT-0249, two structurally distinct NLRP3 inhibitors in clinical development by NodThera, have generated a wealth of preclinical and clinical data demonstrating brain-penetration and broad anti-inflammatory effects, with NT-0796 being the first NLRP3 inhibitor to show reduced neuroinflammation in the clinic.
  • Our ongoing Phase IIa study in obese individuals at cardiovascular risk will further validate these pre-clinical findings.”
    Reversal of High Fat Diet-Induced Obesity, Systemic Inflammation, and Astrogliosis by the NLRP3 Inflammasome Inhibitors NT-0249 and NT-0796.

Walden Biosciences Expands Research Collaboration with the University of Michigan

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수요일, 1월 10, 2024
Kidney, University, Research, Fibrinolysis, Partnership, Science, U-M, Genetics, Kidney disease, Plasma, Causality, Mendelian randomization, Data analysis, Trial of the century, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed biotechnology company focused on transforming the treatment of kidney disease, today announced that it has broadened its research collaboration with the University of Michigan at Ann Arbor (U-M).

Key Points: 
  • Includes biomarker analysis from Walden’s Phase 1+ clinical study with Walden’s humanized anti-suPAR antibody, WAL0921
    CAMBRIDGE, Mass., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed biotechnology company focused on transforming the treatment of kidney disease, today announced that it has broadened its research collaboration with the University of Michigan at Ann Arbor (U-M).
  • A key element of the expansion of the collaboration is the inclusion of biomarker analysis of plasma samples from Walden’s Phase 1+ clinical study of WAL0921.
  • Walden and U-M’s Principal Investigator, Salim Hayek, M.D., previously announced a collaboration, in July 2022, to advance cutting-edge research in the area of genetics and the Mendelian randomization analysis of suPAR.
  • “Our collaboration with Walden continues to be productive and underscores the importance of collaborations between companies and universities in driving innovation.

Walden Biosciences to Host Virtual Event on November 14, 2023 “Transforming the Treatment Landscape of Chronic Kidney Disease”

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화요일, 11월 7, 2023
Kidney, Chronic kidney disease, EST, Senior, CKD, University of Michigan, Fibrinolysis, University of Erlangen–Nuremberg, University, Pharmaceutical industry

CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed clinical-stage company focused on transforming the treatment of kidney diseases, today announced that management will host a virtual event titled, “Transforming the Treatment Landscape of Chronic Kidney Disease,” (CKD) on November 14, 2023 from 11:00 a.m. to 12:30 p.m. EST.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed clinical-stage company focused on transforming the treatment of kidney diseases, today announced that management will host a virtual event titled, “Transforming the Treatment Landscape of Chronic Kidney Disease,” (CKD) on November 14, 2023 from 11:00 a.m. to 12:30 p.m. EST.
  • The program will include remarks from executive and scientific management relating to Walden’s clinical and preclinical programs, where they are pursuing disease-modifying treatments for kidney diseases.
  • (University of Michigan, Kidney Health Initiative) and Mario Schiffer, M.D.
  • (Friedrich-Alexander-University Erlagen-Nürnberg) to discuss the CKD treatment landscape and the great need for better therapeutic options for this patient population.

Centessa Pharmaceuticals to Present Additional 52-Weeks of Continuous Treatment Data from Third Year of Ongoing Phase 2a Study of SerpinPC for the Treatment of Hemophilia at American Society of Hematology (ASH) Annual Meeting

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목요일, 11월 2, 2023
Fibrinolysis, Person, Policy, Haemophilia, Serpin, Society, ASH, Pharmacokinetics, Male, APC, 52 Weeks Make A Year, Part, PWH, Safety, CNTA, Pharmaceutical industry

SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.

Key Points: 
  • SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.
  • The Phase 2a study (AP-0101) is a first-in-human open-label multicenter study to investigate the safety, tolerability, pharmacokinetics and efficacy of subcutaneous doses of SerpinPC in male participants with severe hemophilia.
  • The Company has reported results from Parts 1-4, with results from Parts 3 and 4 shared during an oral presentation at ASH on December 10, 2022 .
  • Centessa plans to make the poster available at https://investors.centessa.com/events-presentations after the session concludes and in accordance with ASH’s embargo policy.

World Hematology and Coagulation Market Research Report 2023: A Nearly $10 Billion-Dollar Market - Demand for Decentralized Testing, New Technologies and Aging Populations Bolsters Growth - ResearchAndMarkets.com

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화요일, 6월 6, 2023
Health, Biotechnology, Platelet, Hematocrit, Stroke, Decentralization, Segment, Enzyme, Ageing, Artery, Cell, Fibrinolysis, Government, Literature, Protein, Bone marrow, PTT, Hemostasis, CBC, Laboratory, Country Markets, Blood, Anemia, IVD, Reticulocyte, Automation, Cryptocurrency, Microscope, Birth control, Renewable energy, Coagulation, Hematology

There is a nearly $10 billion-dollar market for hematology and coagulation IVD testing.

Key Points: 
  • There is a nearly $10 billion-dollar market for hematology and coagulation IVD testing.
  • Increasingly growth is driven by new technologies, the aging population, and the demand for decentralized testing.
  • The basis of hematology testing is the complete blood count (CBC) that provides information on blood components: hemoglobin, hematocrit, red blood cells, white blood cells, reticulocytes, and platelets.
  • The CBC is run as part of the normal work up in an annual health exam and for every inpatient.

Walden Biosciences Announces First Subject Dosed in First-in-Humans Phase 1 Clinical Trial of WAL0921, in Development for Treatment of Chronic Kidney Diseases

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월요일, 6월 5, 2023
PK, ESRD, PD, Kidney, Monoclonal antibody, Safety, Pharmacodynamics, Pharmacokinetics, Proteinuria, Patient, Podocyte, Evaluation, Fibrinolysis, Kidney disease, Pharmaceutical industry

CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, Series B, venture-backed clinical development stage company focused on transforming the treatment of kidney diseases, today announced that the first subject was dosed in the Company’s Phase 1 clinical trial of WAL0921 in healthy subjects. WAL0921 is the Company’s first in class, proprietary, humanized monoclonal antibody that binds soluble urokinase plasminogen activator receptor (suPAR), inhibiting the pro-inflammatory action that causes podocyte dysfunction and renal disease.

Key Points: 
  • Trial to Evaluate Proprietary Human anti-suPAR Monoclonal Antibody for Safety, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
    CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, Series B, venture-backed clinical development stage company focused on transforming the treatment of kidney diseases, today announced that the first subject was dosed in the Company’s Phase 1 clinical trial of WAL0921 in healthy subjects.
  • WAL0921 is the Company’s first in class, proprietary, humanized monoclonal antibody that binds soluble urokinase plasminogen activator receptor (suPAR), inhibiting the pro-inflammatory action that causes podocyte dysfunction and renal disease.
  • “Dosing the first subject in this first human study with WAL0921 is a meaningful milestone for Walden Biosciences that marks our transition to a clinical development company and brings us one step closer to our goal to transform the treatment of kidney disease,” stated Blaine H. McKee, Ph.D., Chief Executive Officer of Walden Biosciences.
  • “Elevated levels of suPAR inflame kidney tissues leading to chronic injury, loss of podocytes, proteinuria, and compromise the whole kidney structure and function, leading ultimately to end stage renal disease (ESRD) in these patients.

Cantex and Michigan Medicine Announce Initiation of a Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Clinical Study to Determine the Safety and Efficacy of Azeliragon in the Treatment of Patients Hospitalized for COVID-19

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목요일, 4월 20, 2023
RAGE, University, AUC, ANN, Receptor (biochemistry), COVID-19, Clinical trial, Cancer, Research, Trial of the century, Lung, Michigan Medicine, Incidence, Acute kidney injury, Medical director, Patient, Kidney, Immune system, Fibrinolysis, Health, Breast cancer, Safety, Chronic kidney disease, Neoadjuvant therapy, Disease, Pharmaceutical industry

Cantex's azeliragon is an orally administered inhibitor of the receptor for advanced glycation end products (known as RAGE).

Key Points: 
  • Cantex's azeliragon is an orally administered inhibitor of the receptor for advanced glycation end products (known as RAGE).
  • Excessive activation of RAGE has been strongly implicated in life-threatening complications of COVID-19 infection, including lung and kidney failure.
  • A protein produced by the immune system, known as "suPAR", at high levels predisposes patients to acute kidney injury during critical illnesses, including severe COVID-19.
  • "We are pleased to collaborate with Dr. Hayek and his colleagues at Michigan Medicine on this important clinical trial.

Ascension Healthcare Announces Positive Data from Phase 2 Study of XLR8 in Severe Haemophilia A Patients

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월요일, 12월 12, 2022
Haemophilia, Bleeding, Use, Prevalence, FDA, Factor VIII, University College London, Gold, VIII, PEGylation, Osteoarthritis, Coronavirus Scientific Advisory Board (Turkey), Fibrinolysis, Potency, Haemophilia A, History, Standard of care, XLR8, Risk, Male, Ascension, Patient, Vaccine, Pharmaceutical industry, Birth control

Haemophilia A patients lack sufficient factor VIII clotting factors which leaves them at risk of uncontrolled bleeding.

Key Points: 
  • Haemophilia A patients lack sufficient factor VIII clotting factors which leaves them at risk of uncontrolled bleeding.
  • This trial was designed to demonstrate that administration of PEGLip, following a normal dose of prophylactic, standard half-life FVIII in severe, non-inhibitor Haemophilia A patients can both enhance clotting activity and extend the dosing interval beyond FVIII administered alone.
  • Results from the study demonstrated that clotting activity was significantly improved at certain time points over baseline and over injection of FVIII alone.
  • The therapy is primarily aimed at f severe patients who are receiving standard of care prophylaxis with intravenous FVIII, where the adjuvant will extend their FVIII dosing interval, thereby improving compliance.

Ascension Healthcare Announces Positive Data from Phase 2 Study of SelectAte in Severe Haemophilia A Patients with inhibitors

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월요일, 12월 12, 2022
Haemophilia, Bleeding, Prevalence, Antibody, FDA, Factor VIII, University College London, VIII, Osteoarthritis, Coronavirus Scientific Advisory Board (Turkey), Fibrinolysis, Haemophilia A, History, Risk, Male, Selective serotonin reuptake inhibitor, Ascension, Patient, Pharmaceutical industry

SelectAte is a proprietary pre-mixed combination of a recombinant factor VIII clotting protein and PEGylated liposomes (PEGLip), co-injected intravenously.

Key Points: 
  • SelectAte is a proprietary pre-mixed combination of a recombinant factor VIII clotting protein and PEGylated liposomes (PEGLip), co-injected intravenously.
  • These results were achieved in both non-inhibitor patients and also those that were both inhibitor prone and presenting with low levels of inhibitors.
  • SelectAte is being developed to treat severe HA patients who have developed inhibitors (neutralising antibodies) to FVIII.
  • Approximately 30% of severe HA patients develop inhibitors to prophylactic FVIII replacement therapy, rendering such therapy ineffective.