More Results for Nerandomilast Reported by BI, This Time for Progressive Pulmonary Fibrosis

An experimental drug for a form of interstitial lung disease (ILD) characterized by worsening of the scarring of lung tissue has produced positive results in a phase 3 trial that could lead to its FDA approval of the drug.

The drug, called nerandomilast, met the primary end point of the trial, significant improvement in forced vital capacity (FVC), a common measure of lung function, according to its maker, Boehringer Ingelheim, a German company with U.S. headquarters in Ridgefield, Connecticut.

The patients enrolled had a condition called progressive pulmonary fibrosis, a consequence of interstitial lung disease.

The announcement of these results in a Feb 10 news release came approximately three weeks after the Boehringer Ingelheim announced similarly positive results for nerandomilast in an affiliate phase 3 trial that enrolled patient with idiopathic pulmonary fibrosis.

In both announcements, Boehringer Ingelheim said it will be submitting a new drug application with FDA and other health regulators.

The trial that enrolled patients with progress pulmonary fibrosis is called Fibroneer-ILD and the one that enrolled patients with idiopathic pulmonary fibrosis, Fibroneer-IPF. Both trials had changes in FVS as their primary end points.

Nerandomilast is an oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). The authors of a study reporting the results of a phase 2 trial of nerandomilast that was published in The New England Journal of Medicine (NEJM) in 2022 said that phosphodiesterase 4 inhibition is associated with anti-inflammatory and antifibrotic properties and that preferential inhibition of the PDE4B subtype may be beneficial in the treatment of idiopathic pulmonary fibrosis because “it may harness these properties” and is also associated with a more acceptable safety profile than nonselective PDE4 inhibitors.

Shashank Deshpande

“The positive Fibroneer-ILD topline result shows the potential of nerandomilast in PPF [progressive pulmonary fibrosis]. The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges,” said Shashank Deshpande, head of human pharma and member of the board of managing directors at Boehringer Ingelheim, said in the news release.

The recent milestones of the Fibroneer trial program underscore our commitment to transforming the lives of patients with this debilitating disease and are a testament to Boehringer Ingelheim's position at the forefront of pulmonary fibrosis research,” Deshpande continued.

Fibroneer-ILD was a double-blind, placebo-controlled that enrolled 1,178 in more than 40 countries. Patients were treated with either a 9 milligram (mg) or 18 mg dose or a placebo, twice daily, over 52 weeks. The 18 mg dose was used in the phase 2 trial. The news release says the 9 mg dose was added to evaluate the “benefit-risk profile” of the lower dose and to provide further dose and exposure-response data. The news release doesn’t provide information on what sort of differences were seen with the two different doses,

The FDA gave nerandomilast breakthrough status in 2022. Breakthrough status is supposed to speed up FDA review of drugs for serious and life-threatening conditions.

The results of phase 2 trial results reported in NEJM showed that nerandomilast seems to have greater effect among patients who haven’t been treated with antifibrotics, which include Ofev (nintedanib) and Esbriet (pirfenidone). Among those who didn’t have a background of antifibrotics, the median change in the FVC was 5.7 milliliters (ml) in the treatment group compared with –81.7 ml in the placebo group, a median difference of 88.4 mil. Among those with a background of antifibrotic use, the median change in the FVC was 2.7 ml in the treatment group compared with –59.2 ml in the placebo group, a median difference of 62.4 ml.