Boehringer Ingelheim reports success in lung fibrosis treatment trials

GERMANY – Boehringer Ingelheim has announced positive results from its second Phase 3 clinical trial evaluating nerandomilast, an experimental oral treatment for lung fibrosis.

This new development builds on the company’s earlier success with the FIBRONEER-IPF study, which focused on idiopathic pulmonary fibrosis (IPF) and was reported in September.

The latest trial, known as FIBRONEER-ILD, tested nerandomilast in patients with progressive pulmonary fibrosis (PPF), a condition where lung scarring worsens over time.

The study involved 1,178 participants who were given either one of two doses of the drug—9 mg or 18 mg—or a placebo, administered twice daily.

At the one-year mark, the treatment showed significant improvement in forced vital capacity (FVC), a key measure of lung function, compared to the placebo.

Boehringer Ingelheim is now preparing to submit regulatory applications based on the results of these trials.

In a statement to Endpoints News, the company confirmed that it has already filed for FDA approval of nerandomilast for IPF and will soon file for PPF.

Comprehensive results from both Phase 3 studies are expected to be shared in the second quarter of 2025.

While the company did not clarify whether both doses met the primary endpoint in this latest trial, these findings strengthen Boehringer Ingelheim’s position as a leader in developing treatments for respiratory and fibrotic lung diseases.

“Nerandomilast in IPF was filed with the FDA last week; filing in PPF will happen in due course,” the company stated.

The field of pulmonary fibrosis treatment has faced significant challenges, with many experimental therapies failing to deliver promising results.

For instance, Novartis recently ended a trial for its IPF treatment, and Pliant Therapeutics paused a Phase 2b study following a safety review.

However, Boehringer’s success with nerandomilast signals progress and offers hope for patients living with these debilitating lung conditions.

In addition to Boehringer’s efforts, other companies are advancing treatments for fibrotic lung diseases.

PureTech Health, for example, announced successful results from a mid-stage study of its IPF therapy in December.