Boehringer Ingelheim’s lung disease drug nerandomilast has been successful in a Phase III study paving the way for the company to seek approval for the asset in a second condition.
Topline data from the Phase III FIBRONEER-ILD trial (NCT05321082) shows that nerandomilast improved lung function in patients with progressive fibrosing interstitial lung diseases (PF-ILDs), excluding those with idiopathic pulmonary fibrosis (IPF). The company previously ran a separate IPF study, which supported its new drug application (NDA) submission last year.
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While the company said the placebo-controlled trial met the primary endpoint of change from baseline in forced vital capacity (FVC) at week 52, it did not disclose data detailing the change, which will be shared in Q2 2025.
The study enrolled 1,178 adult patients who were allowed to continue receiving Ofev (nintedanib), a tyrosine kinase inhibitor (TKI) also developed by Boehringer, during the study.
Off the back of the trial data, Boehringer Ingelheim will submit a NDA for nerandomilast to the US Food and Drug Administration (FDA) and other health authorities for approval in patients with progressive pulmonary fibrosis (PPF).
Head of human pharma and member of the board of managing directors at Boehringer Ingelheim, Shashank Deshpande, said: “The positive FIBRONEER-ILD topline result shows the potential of nerandomilast in PPF. The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges.”
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By GlobalDataThe FIBRONEER-ILD results come five months after a separate Phase III trial of nerandomilast in patients with IPF (NCT05321069), called the FIBRONEER-IPF, also met its primary endpoint of FVC change at 52 weeks. Boehringer Ingelheim has already submitted a separate NDA to the FDA and other agencies for approval of nerandomilast in IPF.
Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). The therapy was granted FDA Breakthrough Therapy Designation for the treatment of IPF in February 2022.
Boehringer dominates IPF space
Boehringer’s Ofev is the standard of care (SOC) and one of only two drugs approved for IPF. The drug is also approved to treat systemic sclerosis-associated interstitial lung disease (SSc-ILD), and other chronic interstitial lung diseases.
In 2023, Boehringer tried to expand its label further with a supplementary NDA submission for paediatric ILD based on data from the Phase III InPedILD (NCT05285982) study, but it was refused by the FDA in March 2024. However, in December 2024, the European Medicine Agency went another way and recommended the label expansion, but at a reduced dose due to adverse events (AEs).
Ofev’s competitor on the IPF and PPF market, Roche’s Esbiret (pirfenidone), saw its sales drop dramatically in 2023, making the company $229.4m compared to the $1.14bn in sales in 2021. This drop was largely attributable to the availability of generic versions of the drug in 2022. There are no generic versions of Ofev available yet, and its sales in 2023 reached $3.8bn increasing by 12.8% compared to the previous year. If approved, nerandomilast could likely be Ofev’s successor in the lung diseases space for Boehringer.
