A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers.

BACKGROUND: P044 is a proposed biosimilar candidate of Teriparatide for reference medicine, Forsteo®. This study was designed to evaluate the Pharmacokinetic/Pharmacodynamic (PK/PD) bioequivalence between P044 and Forsteo®. METHODS: In this randomized, open-label, single-dose, crossover study, 66 healthy female subjects were randomized to receive P044 and Forsteo®. The primary PK endpoints of the study were the area under the concentration versus time from zero to infinity (AUC0-inf) and maximum plasma concentration (Cmax). Secondary endpoints included area under the concentration versus time from zero to the last quantifiable concentration (AUC0-last) and Cmax for PD parameter, additional PK parameters and safety. RESULTS: Sixty-six subjects were enrolled in the study and baseline demographics were similar between the two treatments. The two treatments presented similar PK/PD parameters and the 90% confidence interval for primary and secondary endpoints were within the bioequivalence acceptance range (80.00-125.00%) for all parameters. None of the subjects experienced serious adverse event, and all of the reported adverse events were mild and similar between two treatments. CONCLUSIONS: This study demonstrated the PK/PD similarity of P044 to reference medicine, Forsteo® and safety profiles were comparable between treatments. TRIAL REGISTRATION: EudraCT Number: 2019-004477-82.

Polysaccharides and Their Derivatives as Potential Antiviral Molecules.

In the current context of the COVID-19 pandemic, it appears that our scientific resources and the medical community are not sufficiently developed to combat rapid viral spread all over the world. A number of viruses causing epidemics have already disseminated across the world in the last few years, such as the dengue or chinkungunya virus, the Ebola virus, and other coronavirus families such as Middle East respiratory syndrome (MERS-CoV) and severe acute respiratory syndrome (SARS-CoV). The outbreaks of these infectious diseases have demonstrated the difficulty of treating an epidemic before the creation of vaccine. Different antiviral drugs already exist. However, several of them cause side effects or have lost their efficiency because of virus mutations. It is essential to develop new antiviral strategies, but ones that rely on more natural compounds to decrease the secondary effects. Polysaccharides, which have come to be known in recent years for their medicinal properties, including antiviral activities, are an excellent alternative. They are essential for the metabolism of plants, microorganisms, and animals, and are directly extractible. Polysaccharides have attracted more and more attention due to their therapeutic properties, low toxicity, and availability, and seem to be attractive candidates as antiviral drugs of tomorrow.

Plant-Based Diet as a Strategy for Weight Control.

According to the World Health Organization, obesity has nearly tripled since the 1970s. Obesity and overweight are major risk factors for cardiovascular diseases, diabetes, inflammatory-mediated diseases, and other serious medical conditions. Moreover, recent data suggest that obesity, overweight, diabetes, and cardiovascular diseases are risk factors for COVID-19-related mortality. Different strategies for weight control have been introduced over the last two decades. Unfortunately, these strategies have shown little effect. At the same time, many studies show that plants might be the key to a successful strategy for weight control. Following the PRISMA guidelines for conducting systematic reviews, a search was conducted in PubMed, Web of Science, Scopus, and Embase using the following keywords: obesity, globesity, vegan, plant-based diet, etc. Our results show that vegan diets are associated with improved gut microbiota symbiosis, increased insulin sensitivity, activation of peroxisome proliferator-activated receptors, and over-expression of mitochondrial uncoupling proteins. The key features of this diet are reduced calorie density and reduced cholesterol intake. The combination of these two factors is the essence of the efficiency of this approach to weight control. Our data suggest that plant-based/vegan diets might play a significant role in future strategies for reducing body weight.