Summary
Two clinical trials have shown promising results on the effects of a new drug called nerandomilast for treating idiopathic pulmonary fibrosis (IPF) – the FIBRONEER-IPF trial, and other forms of progressive pulmonary fibrosis (PPF) – the FIBRONEER-ILD trial. The details have been published in the New England Journal of Medicine (see articles here: FIBRONEER-IPF and FIBRONEER-ILD).
The FIBRONEER-IPF trial recruited 1177 patients with IPF from 36 countries, and the FIBRONEER-ILD trial recruited 1176 patients with PPF from 44 countries. Patients were randomly assigned either 9 mg twice a day nerandomilast, 18 mg twice a day nerandomilast or placebo.
Both trials showed that compared with the dummy drug called placebo, the new drug, nerandomilast, slowed down the decline in lung function in patients with IPF and PPF. During these studies, fewer patients died who were on nerandomilast than those who weren’t. The FIBRONEER-IPF trial also showed that the time to needing oxygen treatment due to progression of fibrosis was also longer with nerandomilast. The main side effect of neradomilast was diarrhoea, but patients on the whole didn’t need to stop the drug due to this side effect. This marks an important milestone in the ongoing treatments for IPF and PPF, with a new drug that can slow decline and potentially improve survival in IPF and PPF.
Currently, antifibrotic treatments, nintedanib and pirfenidone, are used for treating IPF, but since their development, no other treatments have been on the market for IPF and other chronic lung diseases that lead to progressive pulmonary fibrosis.
What is nerandomilast?
Nerandomilast is a drug taken by mouth that acts to block the enzyme PDE4 (phosphodiesterase 4) in the body. By blocking this enzyme, it has been shown that it can reduce the development of scarring or fibrosis in animal models.
PDE4 inhibitors are already used to treat various conditions, including psoriasis, psoriatic arthritis, and chronic obstructive pulmonary disease (COPD).
What are IPF and PPF?
IPF is a progressive scarring and stiffening of the lungs that causes breathlessness, dry cough and tiredness. There is no specific cause of IPF, but it is more common in older men who smoke and those with a family history of lung fibrosis. There are lots of other types of lung scarring, and these can also get worse or progress, and we call this progressive pulmonary fibrosis. This includes people with other diseases like systemic sclerosis or rheumatoid arthritis. Similar to IPF, patients with PPF also have symptoms like worsening lung function, breathlessness and dry cough.
What’s next?
Boehringer Ingelheim is currently applying for drug approval from regulatory bodies in different countries, so that nerandomilast can be made available to the public. In the UK, this will involve going through an assessment by a governing body that approves drugs according to whether they work, but also whether they are cost-effective – ie whether they are affordable to the NHS. This is carried out by NICE, and this process can take up to 12 to 18 months, so it will not be known if nerandomilast is allowed to be used for patients with IPF or PPF in the UK until this approval process is completed.
