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What does the latest announcement from Boehringer Ingelheim (BI) about the Fibroneer-IPF clinical trial mean for our community?
A new drug has been tested in a large group of people living with IPF. The first results of this study show that the drug may help people with IPF.
The new drug has been developed by Boehringer Ingelheim (BI). BI is a family-owned biopharmaceutical company that developed the antifibrotic Nintedanib/Ofev, which is a current treatment option for some people living with pulmonary fibrosis (PF).
The pharmaceutical company announced on the 16th September 2024 the topline results from the recent Phase 3 FIBRONEER-IPF clinical trial.
The take home message from this announcement is that a potential new drug for people with idiopathic pulmonary fibrosis (IPF), called nerandomilast, met the main outcome of the trial. The main outcome of the trial was a change in Forced Vital Capacity (FVC) for people who were taking the active drug for 12 months, compared to a placebo. FVC is the amount of air you can blow out from your lungs (measured in ml).
You can read more about the study design, the topline results and the BI press release via our Study Finder.
Why is this news important?
This result is important because it is the first phase 3 IPF clinical trial in over 10 years that has met its primary endpoint - the main outcome of the trial. This is reassuring and welcome news for the many researchers and drug developers working in this space, and most importantly for people affected by PF - we can make a difference through research!
Does this mean a new treatment is available for people living with IPF?
No, not yet. The full effectiveness, safety and side effect information about this potential new treatment will be made public in the first half of 2025. There are still many unanswered questions that need reviewing before we know more about the likelihood of this drug becoming available. Information about any potential side effects experienced by the people who took part in the study; differences between acute exacerbations, hospitalisations, and living with pulmonary fibrosis symptoms scores (including cough, fatigue and breathlessness) will all help to understand the benefits of the new drug.
Will this new drug be available on the NHS?
There is an approval process that needs to be followed before a drug can be prescribed to a patient. We don't know if, when or who would be eligible for treatment should approval be granted. Read more about the drug licensing process.
What about people who do not have IPF?
BI also ran a trial for people with other forms of PF, using the same drug. The information about this trial will be available next year.
What next?
We will provide an update when the full set of results have been announced in 2025. In the meantime, if you have any questions about your current care or are interested in taking part in research, please speak to your healthcare team.