JGL is initiating a phase 3 clinical trial with the ultimate goal of developing an innovative nasal spray for treating the common cold and launching it on the European market. The trial entitled “RhinnovateHA” aims to prove that the innovative combination of two active substances in a nasal spray – hyaluronic acid and xylometazoline – offers superior efficacy, safety and tolerability compared to sprays with a single active substance or placebo. In addition, this is the first time that hyaluronic acid of a specific dose and molecular weight is being proven as an active pharmaceutical substance in formulations for nasal administration.
Accordingly, Investigators Meeting was held in Opatija, bringing together the leading clinical Investigators – ENT specialists and key medical staff from 30 clinical centres that will participate in the trial, which will be conducted on almost 500 patients in Germany, Croatia, Poland and Bulgaria. This is the first time that a study of this scope and significance is being led and financed from Croatia. It is an important achievement for JGL and a step forward in the science and innovation ecosystem of company and the Croatian pharmaceutical industry as a whole.
A multicentre, randomized, double-blind, parallel design clinical trial in adolescent and adult patients with acute viral rhinosinusitis is being conducted in cooperation with the German clinical research institute ClinCompetence Cologne, under the supervision of Prof. Ralph Mösges, PhD, a world-renowned expert in allergology, pulmonology and clinical immunology and member of JGL’s Scientific Advisory Board.
“JGL is the world market leader in the field of seawater-based nasal sprays for a wide variety of indications and is characterised by a willingness to innovate and apply visionary approaches. It was only a matter of time before we joined forces. This unique combination of xylometazoline – a fast-acting molecule for reducing the swelling of the nasal mucosa, and hyaluronic acid – a compound with hydrating and wound healing properties, is a global innovation that is being clinically tested on the very common disease of acute rhinosinusitis or the common cold,” says Prof. Mösges, noting that the trial results are expected in early summer next year. That would enable the innovative spray to appear on the market as early as the winter of 2024/2025. Prof. Mösges believes that rapid innovations of this kind can only be achieved with the seamless interaction of top research teams who are highly specialised and motivated.
Until now, hyaluronic acid was used in nasal sprays exclusively as an excipient at significantly lower concentrations and/or as an ingredient in products with no pharmacological effect.
“We want to offer patients and consumers products that are based on scientifically and clinically sound research, with an element of innovation, while taking into account their needs. It is precisely the balance of innovation, meaning the R&D segment, with business-focused ideas and paying attention to the needs of patients and consumers that we consider necessary for staying competitive in the global market. It is no surprise then that over the last two years JGL has doubled its investments in R&D, in parallel with investing EUR 53 million in the new Integra 2020 investment, which integrates the company's development, production and storage capacities. We are extremely proud of this multinational trial, which will be conducted in 30 clinical centres in four European countries. During the joint meeting, we held a training session about this innovative product, the trial protocol, overall trial-related activities, standard procedures and regulatory framework,” says Zdravka Knežević, PhD, Director of Scientific Operations at JGL, concluding that this development and clinical trial would allow opportunity for JGL in terms of patent and regulatory protection for multi-years.
The trial has already been approved in Germany by the Federal Institute for Drugs and Medical Devices (BfArM) and the Central Ethics Committee, while in other countries (Croatia, Poland, Bulgaria), the approval process is under way. The trial details are accessible and traceable in the European Clinical Trials Database under the unique EudraCT number: 2022-002499-35.