Publications by authors named "M Sumeray"
Context: Hypoparathyroidism is a rare disorder characterized by a deficiency in PTH resulting in hypocalcemia, hyperphosphatemia, and hypercalciuria. Eneboparatide is an investigational peptide agonist of the PTH1 receptor for the treatment of chronic hypoparathyroidism (HP).
Objective: To evaluate the efficacy, safety, and tolerability of eneboparatide in HP patients.
Background: V-306 is a virus-like particle-based vaccine candidate displaying respiratory syncytial virus (RSV) F site II protein mimetics (FsIIm) as an antigenic epitope.
Methods: This was a randomized, placebo-controlled, double-blind, dose-escalating, first-in-human study, conducted in 60 women aged 18-45 years. Twenty subjects per cohort (15 vaccine and five placebo) received two V-306 intramuscular administrations on Days 0 and 56 at 15 µg, 50 µg, or 150 µg.
Article Synopsis
- Epidermolysis bullosa (EB) is a rare genetic disorder causing fragile skin and painful blisters, leading to serious complications like chronic wounds and squamous cell carcinoma.
- The EASE study was a phase III trial that tested Oleogel-S10, a topical gel with birch triterpenes, for improving wound healing in patients with different forms of EB.
- Results showed that 41.3% of patients using Oleogel-S10 achieved complete wound closure within 45 days, compared to 28.9% with a control gel, indicating that Oleogel-S10 is effective and well-tolerated for treating wounds in EB patients.
Background: Epidermolysis bullosa (EB) is a group of rare, genetic diseases that affect the integrity of epithelial tissues, most notably the skin. Patients experience recurrent skin wounding, with severity depending on type, sub-type, and mutation. Oleogel-S10, a formulation of birch bark extract, has demonstrated efficacy in a Phase 2 trial assessing re-epithelialization of wounds in EB.
View Article and Find Full Text PDFPharmacokinetics and Pharmacodynamics of Lomitapide in Japanese Subjects.
J Atheroscler Thromb
May 2016
Aims: Lomitapide is a licensed treatment for patients with homozygous familial hypercholesterolaemia in the USA, the EU, Canada, and Mexico. This study was conducted to compare the pharmacokinetics (PK), pharmacodynamics, safety, and tolerability of lomitapide between Japanese and Caucasian subjects with elevated low-density lipoprotein cholesterol (LDL-C) after single and multiple doses.
Methods: In this randomized, double-blind, placebo-controlled study, 36 Japanese and 36 Caucasian subjects with LDL-C levels ≥110 mg/dL were administered an escalating lomitapide dose range of 10-60 mg or placebo.