Boehringer Ingelheim’s Nerandomilast demonstrates improved lung function in Phase III Trial

GERMANY—Boehringer Ingelheim has announced that its investigational drug, nerandomilast, has achieved positive results in a Phase III clinical trial, potentially leading to its approval for a new lung disease indication.

The FIBRONEER-ILD study focused on patients with progressive fibrosing interstitial lung diseases (PF-ILDs), excluding idiopathic pulmonary fibrosis (IPF).

The trial met its primary goal by showing that nerandomilast improved lung function, as measured by forced vital capacity (FVC), over a 52-week period compared to a placebo.

Detailed data from this study are expected to be released in the second quarter of 2025.

This success follows an earlier Phase III trial, FIBRONEER-IPF, where nerandomilast also met its primary endpoint in patients with IPF.

Based on these findings, Boehringer Ingelheim plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and other global health authorities for the treatment of progressive pulmonary fibrosis (PPF).

Shashank Deshpande, Head of Human Pharma and a member of Boehringer Ingelheim’s Board of Managing Directors, emphasized the significance of these results and highlighted nerandomilast’s potential in treating PPF.

He also expressed optimism that the drug’s safety and tolerability profile could address current treatment challenges.

Nerandomilast is an oral medication that selectively inhibits phosphodiesterase 4B (PDE4B), an enzyme linked to lung inflammatory processes.

 In February 2022, the FDA granted it Breakthrough Therapy Designation for treating IPF, recognizing its potential to offer substantial benefits over existing therapies.

Currently, Boehringer Ingelheim’s Ofev (nintedanib) is a standard treatment for IPF and other chronic interstitial lung diseases.

In 2023, Ofev generated sales of €3.51 billion, marking an 8.8% increase from the previous year. Introducing nerandomilast could further strengthen the company’s position in the respiratory disease market.

In contrast, Roche’s Esbriet (pirfenidone), another treatment for IPF and PPF, experienced a significant decline in sales, dropping to US$229.4 million in 2023 from US$1.14 billion in 2021. This decrease is largely due to the availability of generic versions since 2022.

If approved, nerandomilast may become a successor to Ofev in Boehringer Ingelheim’s portfolio, offering a new therapeutic option for patients with progressive lung diseases.

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