Potential breakthrough in progessive pulmonary fibrosis

A new tablet called nerandomilast could help slow down lung damage in people with progressive pulmonary fibrosis (PPF), according to recent Phase III study results. The medication, developed by Boehringer Ingelheim, performed better than a placebo in protecting lung function, giving hope to patients and their families.

What the study found

The FIBRONEER-ILD (NCT05321082) study included 1,178 adults with progressive forms of pulmonary fibrosis. The study measured lung function over one year. After this time, those taking nerandomilast had better lung function compared to those who took a placebo. While full details are still pending, these results suggest a step forward in treatment options.

What this means for patients

Boehringer Ingelheim is now planning to submit applications to the U.S. Food and Drug Administration (FDA) and other health agencies to get approval for nerandomilast. If approved, this medication could become a new option for those living with PPF.

“The results from FIBRONEER-ILD show that nerandomilast has real potential in treating progressive pulmonary fibrosis,” said Shashank Deshpande, Head of Human Pharma at Boehringer Ingelheim. “We hope its safety and ease of use will make it a valuable option for patients.”

How the medication works

Pulmonary fibrosis causes scarring in the lungs, making it harder to breathe. Nerandomilast (also known as BI 1015550) is designed to slow this scarring by blocking an enzyme called PDE4B, which plays a role in inflammation and fibrosis.

Previous success in idiopathic pulmonary fibrosis (IPF)

This isn’t the first success for nerandomilast. Another Phase III study last year, FIBRONEER-IPF (NCT05321069), showed that it also helped people with IPF, a form of pulmonary fibrosis with no known cause. That study also found that the medication helped preserve lung function.

What happens next?

More detailed safety and effectiveness results from the FIBRONEER-ILD study will be released later this year. So far, the most common side effect reported has been mild diarrhoea, similar to previous trials.

These large-scale studies are crucial steps toward gaining regulatory approval and ensuring that nerandomilast can become a safe and effective treatment option for people with pulmonary fibrosis.

For those living with pulmonary fibrosis, these findings bring new hope. If approved, nerandomilast could become a valuable new tool in managing the disease, helping patients breathe easier and maintain a better quality of life.

You can read the full press release from Boehringer Ingelheim here.

Stay tuned for more updates as further data becomes available.

In the meantime, UCLH are involved in the phase III study of nerandomilast in ILD secondary to autoimmune rheumatic disease (FIBRONEER SARD-ILD study) and are opening recruitment shortly.

 

[Posted Feb 2025]