AbstractBackground and aims
The majority of OTC medicines cannot be used for serious children conditions due to their life-threatening side effects. Aimed to combat existing issues, we are pleased to propose our unique technology of released-active antibodies (RA Abs). This approach is based on the use of Abs to endogenous regulators in a specific form which they acquire after technological treatment, leading to a release of a new sort of activity, namely not the Abs target neutralisation but its modification and even activation. RA drugs’ unique features have been thoroughly investigated for more than 10 years with their efficacy and safety proven in a wide range of studies.Methods
Preclinical experiments were conducted on standard models of the most dangerous and spread children diseases as acute viral respiratory and intestinal infections, including those complicated by secondary immunodeficiency. Clinical trials were performed according to principles of the evidence-based medicine and cGCP. Genes and proteins expression, conformational changes, receptor-binding and functional assays were set up for mechanism of action (MoA) determination. All data were analysed via advanced statistical methods in accordance with the most recent international requirements.Results
Preclinical toxicology studies have shown RA Abs’ complete safety, the same was confirmed by absence of adverse effects or withdrawal in clinics. In a range of top-quality nonclinical studies RA Abs were shown to have antiviral activity against a wide spectrum of pathogens, even those the most dangerous (MERS-related coronavirus) or resistant to the existing therapy (Influenza A/H1N1/pdm09 Oseltamivir-resistant strain). Drugs’ efficacy was equal to that of the reference with similar total quality-of-life scores and no worsening in clinics. Moreover, in series of experiments of joint RA Abs use with the conventional drugs a capacity to increase their efficacy as well as toxicity decrease was demonstrated. RA Abs’ exert their MoA via change of target molecules conformation, reinforcement of receptor-ligand interaction as well as an increase in immune genes expression; thus mildly enhancing immune reactions without its exhaustion.Conclusions
RA Abs represent a new class of medicines with high efficacy and safety, offering an opportunity to treat a broad range of infectious diseases regardless of underlying medical conditions without causing complications typical for other existing drugs.