A phase I clinical trial for a ground-breaking therapeutic innovation against respiratory infections has begun at the Clinical Investigation Centre of the Academic Hospital of Tours, France. The drug ‘FLAMOD’ is a treatment which aims to stimulate the body’s own defences rather than directly target the bacteria.
FLAMOD is to be used as an adjunct to antibiotics to enhance the effectiveness of first-line antibiotic treatment. As part of this trial, FLAMOD, which is derived from a natural bacterial component known as flagellin, will be administered via aerosol using an Aerogen mesh-nebulizer to specifically stimulate the airway immune response. The advantage of this administration route is that it allows for a direct and rapid activation of lung anti-infective defences without triggering a systemic immune response.
The principal investigator of the project, Prof. Antoine Guillon from the Critical Care Section of Tours Hospital, notes: “FLAMOD is a unique approach to the treatment of respiratory infections and one that attends to the ever-increasing concern of antibiotic resistance, as seen in patients with drug-resistant bacterial pneumonia.”
“We must keep in mind that respiratory infections are the third-leading cause of death globally, accounting for approximately three million deaths per year,” Prof. Guillon added.
Dr. Valérie Gissot, Head of the Clinical Investigation Centre, explained that it is not just the innovative strategy of this treatment that makes it unique: “Drug development typically occurs within the pharmaceutical industry. In this case, a network of researchers and doctors collaborated from the inception of the idea to its development for humans, remaining largely within the academic sphere. This was only possible due to funding from the European Union (EU).”
This phase I clinical trial, named NEBUFLAG, marks a significant milestone for the EU-funded FAIR project, which has been underway for the past five years. The project has laid the foundation for this groundbreaking clinical trial. FAIR Project Coordinator, Dr Jean-Claude Sirard, stated: "The FAIR project has made remarkable progress in paving the way for the first phase I clinical trial in humans with nebulised flagellin.
"I am thrilled by the dedication demonstrated by our partners in conducting impressive preclinical studies, modelling toxicological doses, and developing unique tests tailored to the clinical trial. The ongoing stratification of pneumonia patients in the Netherlands will be crucial in advancing personalised medicine for the most vulnerable individuals.”
Promising results from the FAIR experimental and preclinical studies further support the potential of FLAMOD in treating respiratory infections. The NEBUFLAG phase I clinical trial is expected to end by late 2026.
Visit the project website: https://www.fair-flagellin.eu/
