Nerandomilast shows promise for progressive pulmonary fibrosis
Treatment candidate bests placebo at preserving lung function in study
Nerandomilast, an oral treatment being developed by Boehringer Ingelheim, bested a placebo at preserving lung function in adults with progressive pulmonary fibrosis in a Phase 3 study, according to top-line data announced by the company.
With those results, nerandomilast met the primary endpoint, or goal, of the study, dubbed FIBRONEER-ILD, Boehringer noted in a company press release.
Based on the study findings, the company is now planning to submit applications to the U.S. Food and Drug Administration and other regulatory authorities to seek approval of nerandomilast for treating progressive pulmonary fibrosis.
“The positive FIBRONEER-ILD top-line result shows the potential of nerandomilast in progressive pulmonary fibrosis,” said Shashank Deshpande, head of human pharma and member of the board of managing directors at Boehringer. “The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges.”
Developer to seek treatment’s approval for progressive pulmonary fibrosis
This is the second Phase 3 trial of nerandomilast to hit its main goal. Boehringer last year announced positive data from FIBRONEER-IPF (NCT05321069), which tested the therapy against a placebo in more than 1,000 people with idiopathic pulmonary fibrosis (IPF), or patients in whom the disease has no known cause. Those results showed nerandomilast led to better lung function among participants after one year.
“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 said.
Pulmonary fibrosis is marked by the abnormal buildup of scar tissue in the lungs. Nerandomilast, also known as BI 1015550, is designed to reduce lung scarring by blocking the activity of phosphodiesterase 4B, or PDE4B, a pro-inflammatory enzyme involved in scar formation.
The recent milestones of the FIBRONEER trial program underscore our commitment to transforming the lives of patients with this debilitating disease.
The Phase 3 FIBRONEER-ILD trial (NCT05321082) enrolled 1,178 adults with progressive forms of pulmonary fibrosis other than IPF. Participants were randomly assigned to take one of two doses of nerandomilast (9 or 18 mg), or a placebo, twice daily for about a year. The study enrolled patients in more than 40 countries, per Boehringer.
Its main goal was to assess the treatment’s impact on forced vital capacity, or FVC, a common measure of lung function that indicates how much air a person can forcibly exhale after a deep breath. According to Boehringer, the results showed that nerandomilast led to more favorable changes in FVC values after a year compared with placebo. The company did not provide details on the efficacy data, however.
The company also didn’t provide specifics on safety outcomes. It did note that the safety profile of nerandomilast in this Phase 3 study was generally comparable with safety findings seen in another previous Phase 2 trial (NCT04419506) that tested the therapy in people with IPF. In that trial, the most common side effect of nerandomilast was diarrhea.
Full safety and efficacy data from FIBRONEER-ILD will be announced later this year, according to Boehringer.
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