GERMANY—Boehringer Ingelheim, a global biopharmaceutical company known for its human and animal health contributions, has reported positive results from its FIBRONEER™-IPF trial.

The trial, which assessed the efficacy of nerandomilast, met its primary endpoint, marking a significant milestone in the treatment of idiopathic pulmonary fibrosis (IPF).

The primary measure was the absolute change from baseline in Forced Vital Capacity (FVC) at week 52, a critical marker of lung function, compared to a placebo group.

The FIBRONEER™-IPF trial was a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of nerandomilast over at least 52 weeks in patients with IPF.

This trial is part of the broader FIBRONEER™ program, which includes two Phase III trials — FIBRONEER™-IPF (NCT05321069) and FIBRONEER™-ILD (NCT05321082).

 These studies aim to investigate nerandomilast’s efficacy, safety, and tolerability in patients with IPF as well as those with progressive pulmonary fibrosis (PPF), a condition that develops from various interstitial lung diseases (ILDs).

Following the positive results from the FIBRONEER™-IPF trial, Boehringer Ingelheim plans to submit a New Drug Application (NDA) for nerandomilast to the U.S. Food and Drug Administration (FDA) and other health regulatory authorities around the globe.

The FDA granted nerandomilast Breakthrough Therapy Designation in 2022, highlighting its potential to address the high unmet medical needs of IPF patients.

Commenting on the achievement, Joannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim, highlighted the significance of the trial, stating that it is the first Phase III trial for IPF in over a decade to meet its primary endpoint.

He emphasized that this announcement marks a major step forward in the company’s longstanding research efforts in IPF.

Sapountzis also acknowledged the urgent need for more treatment options, as IPF remains one of the most prevalent and debilitating interstitial lung diseases.

Despite the promising findings, nerandomilast, an oral investigational phosphodiesterase 4B (PDE4B) inhibitor, remains an investigational drug, and its safety and efficacy have not yet been fully established.

The FIBRONEER™ global program, which includes the FIBRONEER™-IPF and FIBRONEER™-ILD trials, is crucial in further exploring this treatment’s potential for patients with both IPF and PPF.

IPF is one of the more prevalent progressive fibrosing ILDs, a group of lung diseases characterized by scarring of the lung tissue.

Common symptoms include shortness of breath during physical activity, persistent dry cough, chest discomfort, fatigue, and weakness.

Although classified as a rare disease, IPF affects an estimated 3 million people globally, primarily impacting individuals over 50 years of age, with men being more affected than women.

In addition to IPF, some patients with other fibrosing ILDs may develop a progressive phenotype known as progressive pulmonary fibrosis (PPF).

This condition is defined by worsening respiratory symptoms, as well as physiological and radiological evidence of disease progression, further highlighting the urgent need for effective treatments such as nerandomilast.

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