1340. Population Pharmacokinetic (PK) Analysis of APX001 Using Phase 1 Data
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DOI: 10.1093/ofid/ofy210.1172
Abstract: Abstract Background APX001 is a novel antifungal agent which is rapidly converted to the active metabolite APX001A. APX001A exhibits in vitro activity against many clinically important yeast and fungi, including echinocandin- and azole-resistant Candida species.… read more here.
Keywords: research; apx001; amplyx pharmaceuticals; ppk model ... See more keywords
FRI0227 Sarilumab significantly suppresses circulating biomarkers of bone resorption and cardiovascular risk compared with adalimumab: biomarker analysis from the phase 3 monarch study
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DOI: 10.1136/annrheumdis-2017-eular.4534
Abstract: Background MONARCH (NCT02332590) was a randomized, active-controlled, double-blind, double-dummy, phase 3 superiority trial comparing sarilumab monotherapy with adalimumab monotherapy. Exploratory biomarkers associated with inflammation, bone erosion, and cardiovascular (CV) risk were evaluated in this study.… read more here.
Keywords: risk; adalimumab; regeneron pharmaceuticals; pharmaceuticals inc ... See more keywords
THU0223 Impact of treatment in patients with rheumatoid arthritis and depressive symptoms in the monarch phase 3 trial of sarilumab
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DOI: 10.1136/annrheumdis-2018-eular.3714
Abstract: Background In the MONARCH Phase 3 randomised controlled trial (RCT) [NCT02332590], sarilumab subcutaneous (SC) 200 mg every 2 weeks (q2w) improved clinical outcomes and multiple aspects of health status/health-related quality of life (HRQoL), as measured by… read more here.
Keywords: shareholder; sanofi; employee; regeneron pharmaceuticals ... See more keywords
FRI0120 HIGH LEVELS OF INTERLEUKIN-6 (IL-6) IN RA PATIENTS ARE ASSOCIATED WITH GREATER IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES (PROS) FOR SARILUMAB COMPARED WITH ADALIMUMAB
Sign Up to like & getrecommendations! Published in 2019 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2019-eular.3294
Abstract: Background Increased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and are predictive of therapeutic responses in patients with RA. IL-6 has been implicated in fatigue, pain and depression in RA but a formal association… read more here.
Keywords: high levels; treatment; regeneron pharmaceuticals; regeneron ... See more keywords
OP0241 SAFETY AND EFFICACY OF LENABASUM IN AN OPEN-LABEL EXTENSION OF A PHASE 2 STUDY OF LENABASUM IN REFRACTORY SKIN-PREDOMINANT DERMATOMYOSITIS (DM) SUBJECTS
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DOI: 10.1136/annrheumdis-2019-eular.3397
Abstract: Background Lenabasum is a synthetic, non-immunosuppressive, selective cannabinoid receptor type 2 agonist that activates resolution of innate immune responses. Lenabasum had acceptable safety and tolerability and improved efficacy outcomes in the initial 16-week double-blinded, randomized,… read more here.
Keywords: corbus pharmaceuticals; efficacy; none declared; safety ... See more keywords
FRI0108 ASSOCIATION BETWEEN CHANGES IN C-REACTIVE PROTEIN AT WEEK 12 AND PATIENT-REPORTED OUTCOMES AT WEEK 24 WITH SARILUMAB THERAPY ACROSS THREE PIVOTAL PHASE 3 STUDIES
Sign Up to like & getrecommendations! Published in 2020 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/annrheumdis-2020-eular.2181
Abstract: Background: Evaluation of early response to rheumatoid arthritis (RA) therapy at 12 weeks after initiation is recommended in treatment guidelines. C-reactive protein (CRP) response at 12 weeks on therapy may indicate favorable longer-term patient-reported outcomes… read more here.
Keywords: regeneron pharmaceuticals; regeneron; monarch; sanofi genzyme ... See more keywords
Ravulizumab (ALXN1210) Versus Eculizumab in Adults with Paroxysmal Nocturnal Hemoglobinuria: Pharmacokinetics and Pharmacodynamics Observed in Two Phase 3 Randomized, Multicenter Studies
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DOI: 10.1182/blood-2018-99-110858
Abstract: Background/Objective: In 2 large, phase 3 clinical studies, ravulizumab (ALXN1210), an innovative C5 inhibitor administered every 8 weeks, achieved noninferiority to eculizumab in complement inhibitor-naive and -experienced patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH). The… read more here.
Keywords: pharmaceuticals inc; eculizumab; honoraria; research funding ... See more keywords
Transmembrane Protease, Serine 6 (TMPRSS6) Antisense Oligonucleotide (IONIS-TMPRSS6-LRX) Reduces Plasma Iron Levels of Healthy Volunteers in a Phase 1 Clinical Study
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DOI: 10.1182/blood-2018-99-115339
Abstract: Iron overload is the major cause of morbidity and mortality in beta-thalassemia patients. The low levels of beta-globin and ineffective erythropoiesis in these patients result in the suppression of hepcidin. The inappropriately low levels of… read more here.
Keywords: ionis pharmaceuticals; tmprss6; pharmaceuticals inc; ionis ... See more keywords
Pozelimab, a Human Antibody Against Complement Factor C5, Demonstrates Robust Inhibition of Alternative Complement Activity Both in Normal Human Serum and in Phase I Normal Healthy Volunteers
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DOI: 10.1182/blood-2019-129865
Abstract: INTRODUCTION: Blockade of complement factor C5 has demonstrated benefit in paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica. We have completed a Phase I study of pozelimab, a fully human… read more here.
Keywords: regeneron pharmaceuticals; hemolysis; employment equity; pharmaceuticals inc ... See more keywords
Gene Therapy for Fanconi Anemia, Complementation Group a: Updated Results from Ongoing Global Clinical Studies of RP-L102
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DOI: 10.1182/blood-2020-137106
Abstract: Background: Fanconi anemia (FA) is a rare inherited disorder of defective cellular deoxyribonucleic acid (DNA) repair, associated with developmental abnormalities and characterized by progressive bone marrow failure (BMF) and a predisposition to hematologic malignancies and… read more here.
Keywords: current equity; rocket pharmaceuticals; company; pharmaceuticals inc ... See more keywords
Optimization of Dose Regimen for ALXN1210, a Novel Complement C5 Inhibitor, in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Results of 2 Phase 1/2 Studies
Sign Up to like & getrecommendations! Published in 2017 at "Blood"
DOI: 10.1182/blood.v130.suppl_1.3482.3482
Abstract: Background : ALXN1210 is a rationally designed humanized monoclonal antibody to complement component 5 (C5), engineered to achieve extended half-life and duration of complement inhibition while retaining the proven efficacy and safety of eculizumab. Objective… read more here.
Keywords: pharmaceuticals inc; alexion pharmaceuticals; induction; complement inhibitor ... See more keywords