Balasubrahmanyam Budda
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View article: Development of AL101 (GSK4527226), a progranulin-elevating monoclonal antibody, as a potential treatment for Alzheimer’s disease
Development of AL101 (GSK4527226), a progranulin-elevating monoclonal antibody, as a potential treatment for Alzheimer’s disease Open
Clinicaltrials.gov, NCT04111666. Registered on October 1, 2019. https://clinicaltrials.gov/ct2/show/NCT04111666 .
View article: Population Pharmacokinetic/Pharmacodynamic and Exposure‐Response Modeling Analyses of Sotatercept in Healthy Participants and Patients with Pulmonary Arterial Hypertension
Population Pharmacokinetic/Pharmacodynamic and Exposure‐Response Modeling Analyses of Sotatercept in Healthy Participants and Patients with Pulmonary Arterial Hypertension Open
Sotatercept is a breakthrough, first‐in‐class biologic, recently approved by the Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). Exposure‐response (E‐R) analyses and pharmacokinetic/pharmacody…
View article: PROGRESS‐AD: a phase 2 study to evaluate efficacy and safety of GSK4527226 (AL101), an anti‐sortilin monoclonal antibody, in patients with early Alzheimer’s disease
PROGRESS‐AD: a phase 2 study to evaluate efficacy and safety of GSK4527226 (AL101), an anti‐sortilin monoclonal antibody, in patients with early Alzheimer’s disease Open
Background Progranulin (PGRN), a glycoprotein secreted by microglia and neurons, regulates lysosomal function, neuroinflammation, and has neurotrophic effects. Variants in the granulin gene ( GRN ) that cause a reduction of PGRN in plasma …
View article: Preclinical and first-in-human evaluation of AL002, a novel TREM2 agonistic antibody for Alzheimer’s disease
Preclinical and first-in-human evaluation of AL002, a novel TREM2 agonistic antibody for Alzheimer’s disease Open
View article: Population pharmacokinetic modeling of sotatercept in healthy participants and patients with pulmonary arterial hypertension
Population pharmacokinetic modeling of sotatercept in healthy participants and patients with pulmonary arterial hypertension Open
Sotatercept is a breakthrough, first‐in‐class biologic, that is FDA‐approved for the treatment of pulmonary arterial hypertension (PAH). A population pharmacokinetic (PopPK) model was developed using data from two phase 1 studies in health…
View article: Phase 1 study of latozinemab in progranulin‐associated frontotemporal dementia
Phase 1 study of latozinemab in progranulin‐associated frontotemporal dementia Open
INTRODUCTION Heterozygous mutations in the GRN gene lead to reduced progranulin (PGRN) levels in plasma and cerebrospinal fluid (CSF) and are causative of frontotemporal dementia (FTD) with > 90% penetrance. Latozinemab is a human monoclon…
View article: Population Pharmacokinetics and Exposure‐Response Relationship of Luspatercept, an Erythroid Maturation Agent, in Anemic Patients With β‐Thalassemia
Population Pharmacokinetics and Exposure‐Response Relationship of Luspatercept, an Erythroid Maturation Agent, in Anemic Patients With β‐Thalassemia Open
β‐Thalassemia is an inherited blood disorder resulting from defects in hemoglobin production, leading to premature death of red blood cells (RBCs) or their precursors. Patients with transfusion‐dependent β‐thalassemia often need lifelong r…
View article: Population Pharmacokinetics and Exposure–Response of Luspatercept, an Erythroid Maturation Agent, in Anemic Patients With Myelodysplastic Syndromes
Population Pharmacokinetics and Exposure–Response of Luspatercept, an Erythroid Maturation Agent, in Anemic Patients With Myelodysplastic Syndromes Open
Luspatercept is a recombinant fusion protein that enhances late‐stage erythroid maturation. This report describes the population pharmacokinetics and exposure–response relationship of luspatercept in 260 patients with anemia due to myelody…