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Milestone clinical trial gives hope for new drug treatment
A new drug has shown positive results in a clinical trial for people with progressive pulmonary fibrosis (PPF).
The results from the FIBRONEER™-ILD trial could represent an important step forward for the pulmonary fibrosis community. If the drug, nerandomilast, is approved, it could become a new treatment option in the future.
For people with PPF, the news is a step forwards, and it provides hope for potential new treatments on the horizon.
This news follows the positive announcement made by Boehringer Ingelheim last year about the FIBRONEER-IPF study, which saw the same investigational drug show positive results for people with IPF.
For more details, see the Boehringer Ingelheim press release.
Key Insights from the Trial Results
The take home message from this announcement is that a potential new drug for people with PPF 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 a breathing test for the amount of air you can blow out from your lungs (measured in ml).
What do these results mean for people with progressive pulmonary fibrosis?
PPF can significantly impact quality of life, making it harder to breathe and do everyday activities. Currently, treatment options for PPF are limited, and new therapies are urgently needed. The positive results from this trial bring hope to the PPF community, that we can make a difference through research.
The full effectiveness, safety and side effect information about this potential new treatment will be made public in the second quarter of 2025. There are still many unanswered questions that need reviewing before we know more about the likelihood of this drug becoming available to people with PPF.
We welcome the encouraging results of this potential new treatment for progressive pulmonary fibrosis. This underscores the vital role of medical research in advancing treatment options and brings hope to those affected by this devastating condition in the future. Every step forward in research brings us closer to better outcomes and improved quality of life for people living with pulmonary fibrosis.
Daniel Saxton, Chief Executive, Action for Pulmonary Fibrosis
What is a Phase 3 Clinical Trial?
A Phase 3 clinical trial is the final stage of testing before a drug can be considered for regulatory approval. These trials involve a large number of people taking part, compared to earlier phase research. They are designed to confirm a drug's effectiveness, monitor side effects, compare it to standard treatments, and collect information that will allow the drug to be used safely. Phase 3 trials are critical in for understanding whether a new treatment should be approved.
What is nerandomilast?
Nerandomilast is an oral medication being studied for the potential treatment of PPF. Nerandomilast is still in development, meaning it has not yet been approved for use by health authorities and it is not yet available on the NHS.
What is progressive pulmonary fibrosis?
Progressive pulmonary fibrosis (PPF) is a group of lung diseases that can occur in people with certain forms of interstitial lung disease (ILD). In PPF, the lungs become increasingly scarred over time, leading to difficulty breathing. As the disease progresses, it can cause severe lung damage and even lead to premature death.
The most common forms of PPF can include:
- Connective tissue disease-ILDs
- Fibrotic hypersensitivity pneumonitis
- Exposure-related ILDs (asbestosis, silicosis, etc.)
- Drug-induced ILDs (amiodarone, nitrofurantoin, etc.)
- Sarcoidosis
- Anti-neutrophilic cytoplasmic auto-antibody-associated vasculitis
- Unclassifiable ILD
PPF diseases are often difficult to diagnose, as they can resemble other forms of lung disease. However, early detection and treatment are crucial to managing the disease and slowing its progression.
The FIBRONEER™-ILD Trial Results
In the FIBRONEER™-ILD trial, which involved nearly 1,200 patients across more than 40 countries, nerandomilast met its primary endpoint, which is the main outcome of the trial: the change in forced vital capacity (FVC), a measure of lung function, after 52 weeks. The initial results showed that patients who received nerandomilast may have a slower rate of lung function decline compared to those who were given a placebo. A placebo (dummy drug) looks identical to the drug that is being investigated, but it does not contain any active ingredients.
In addition to lung function, the trial also looked at other important aspects of health, safety and how people cope with taking the drug.
The full results are expected to be published in the second quarter of 2025, where we will then know more about the impact of the new drug.
To find out more about what the study involved, take a look at our Study Finder.
What’s next for nerandomilast?
Following the announcement of the FIBRONEER™-ILD trial topline results, the manufacturer plans to submit a new drug application for nerandomilast to the regulatory authorities around the world. This is the first step towards making nerandomilast available to people living with PPF. It will still need to go through regulatory review before it can be prescribed by doctors, and there are many stages to this meaning that there is always a possibility that it won’t become available. This process can take a long time, meaning that there will be no immediate changes to treatment options.
More detailed insights into the drug’s long-term effects will be published later in the year.
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, which can take a long time. At this stage, 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 happens and the timelines expected before access to drugs can be granted. We will provide updates when we know more.
What does this mean for the pulmonary fibrosis community?
The results from the FIBRONEER™-ILD and FIBRONEER™-IPF trials could represent an important milestone for the pulmonary fibrosis community. If nerandomilast is approved, it could become a new treatment option.
For people living with pulmonary fibrosis, the news is a step toward more treatment options becoming available, and it provides hope for the future.
What next?
We will provide an update when the full set of results have been announced later 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.
For more information about the FIBRONEER™-ILD announcement, visit the Boehringer Ingelheim’s press release.
If you are interested in taking part in research, take a look at all the different opportunities available in the UK on our Study Finder. You can also find information about previous research and the results available.