Publications by authors named "Sylvia Dobo"
Galidesivir (BCX4430) is an adenosine nucleoside analog broadly active in cell culture against multiple RNA virus families, and active in animal models of viral diseases associated with Ebola, Marburg, yellow fever, Zika, and Rift Valley fever. Current studies demonstrated the pharmacokinetics and safety of the first-in-human evaluations of galidesivir as intramuscular (IM) and intravenous (IV) formulations. Two double-blind, placebo-controlled, dose-ranging studies were conducted enrolling 126 healthy subjects.
View Article and Find Full Text PDFBackground: Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein recently approved for prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). The objective of this report is to summarize results from an interim analysis of an ongoing long-term safety study of berotralstat in patients with HAE.
Methods: APeX-S is an ongoing, phase 2, open-label study conducted in 22 countries (ClinicalTrials.
Article Synopsis
- There is a critical need for long-term treatment options for hereditary angioedema (HAE) in Japan, as current approved therapies are lacking; Berotralstat (BCX7353) is being developed as an oral, once-daily treatment to prevent angioedema attacks.
- The APeX-J trial is a phase 3 study that involved patients with type 1 or 2 HAE and assessed the effectiveness of berotralstat in reducing the frequency of angioedema attacks compared to a placebo over a 24-week period.
- Results showed that the higher dose of berotralstat (150 mg) significantly decreased the number of HAE attacks compared
Article Synopsis
- Berotralstat (BCX7353) is an oral medication under investigation for preventing hereditary angioedema (HAE) attacks, aimed at assessing its efficacy and safety over a 24-week study (APeX-2 trial).
- The trial involved 121 patients who were randomly assigned to receive either a daily dose of 110 mg or 150 mg of berotralstat, or a placebo, with the primary goal of measuring the frequency of HAE attacks.
- Results indicated that both doses of berotralstat significantly reduced attack rates compared to placebo, with minimal side effects, and the higher 150 mg dosage showed the best safety profile.
Article Synopsis
- Hereditary angioedema is a serious genetic condition that leads to severe swelling due to mutations affecting the C1 inhibitor, which can be addressed by the oral drug BCX7353 that inhibits plasma kallikrein.
- In a clinical trial involving 77 patients, BCX7353 was tested in four daily doses (62.5 mg to 350 mg) compared to a placebo to prevent angioedema attacks over 28 days, focusing on attack rates and patient quality of life.
- Results showed that daily doses of 125 mg or higher significantly reduced the number of angioedema attacks and improved quality of life, while mild gastrointestinal side effects were the main adverse events reported.
The adenosine nucleoside analog BCX4430 is a direct-acting antiviral drug under investigation for the treatment of serious and life-threatening infections from highly pathogenic viruses, such as the Ebola virus. Cellular kinases phosphorylate BCX4430 to a triphosphate that mimics ATP; viral RNA polymerases incorporate the drug's monophosphate nucleotide into the growing RNA chain, causing premature chain termination. BCX4430 is active in vitro against many RNA viral pathogens, including the filoviruses and emerging infectious agents such as MERS-CoV and SARS-CoV.
View Article and Find Full Text PDFBackground: Current influenza treatment options include oral or inhaled antiviral agents. There is an unmet need for parenteral antiviral treatments.
Methods: Peramivir, a parenteral influenza neuraminidase inhibitor (NAI), was administered by single-dose intramuscular (IM) injection in two placebo-controlled studies in adult outpatients with acute, uncomplicated influenza during two consecutive influenza seasons.