Boehringer Ingelheim score with phase 3 idiopathic pulmonary fibrosis win
Boehringer Ingelheim reported this week that its phase 3 Fibroneer-IPF trial had met its primary endpoint of an improvement in Forced Vital Capacity (FVC), a measure of lung capacity, versus placebo.
“This is the first idiopathic pulmonary fibrosis phase-3-trial in a decade to meet its primary endpoint,” said Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim, in a press statement.
“Today’s announcement represents the next step in our long history in the research of this disease. idiopathic pulmonary fibrosis has a high unmet need for patients, and we are continuously fostering our research activities to develop more options for one of the most common interstitial lung diseases.”
The company is presenting full efficacy and safety data from this trial in early 2025 so the statement this week only included limited data. For example, Boehringer stated that the primary endpoint of the trial –a better FVC score at 52 weeks than placebo– was met, but did not share specific figures.
It also did not share information on the secondary endpoint of the study –the time to the first occurrence of a composite endpoint including a combination of: time to first acute disease exacerbation, first hospitalization for a respiratory cause, or death.
Nerandomilast, an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B), is also being tested in a second phase 3 trial for treatment of progressive fibrosing interstitial lung diseases.
Meeting an unmet need
Idiopathic pulmonary fibrosis is estimated to affect between 20-80 people per 100,000 around the world. It is a degenerative condition characterized by the build up of scarring and fibrosis in the lung tissue over time and a gradual decline in lung function. After diagnosis it has an average 5-year survival rate of 20-40%.
Two medications for this condition have been approved by the FDA, a tyrosine kinase inhibitor called Ofev (nintedanib), also developed by Boehringer, was approved in 2014 and Roche’s Esbriet (pirfenidone) a pyridone drug that blocks substances that cause fibrosis as also given FDA approval in 2014.
Both have been found to delay lung-function decline and death significantly but are only temporary fixes and there is still a significant need in this patient group.
Nerandomilast (previously known as BI1015550) received FDA breakthrough designation in 2022 for the treatment of idiopathic pulmonary fibrosis. This designation allows faster drug development and is only granted if developers can provide good early evidence that their candidate therapy is likely to be a big improvement over currently available treatment options.
There are other new drugs for idiopathic pulmonary fibrosis in development, but most of the other candidate therapies are currently at phase 2 or earlier. For example, Vicore Pharma, Bridge Therapeutics and Pliant Therapeutics all have candidates that have reached phase 2.
Targeting PDE4 allows Boehringer to trigger both antifibrotic and anti-inflammatory effects with nerandomilast, which could be a benefit over currently approved products. There have been problems with headaches and gastrointestinal side effects with drugs of this type before, but the company is hoping that targeting the enzyme subtype PDE4B will help overcome this potential problem as it is preferentially found in the lungs.
