Boehringer Ingelheim achieves phase 3 success in idiopathic pulmonary fibrosis

Boehringer Ingelheim recently announced that its phase 3 Fibroneer-IPF trial has successfully achieved its primary goal of improving Forced Vital Capacity (FVC), a key indicator of lung capacity, compared to a placebo. This significant milestone marks the first idiopathic pulmonary fibrosis (IPF) phase 3 trial in a decade to reach its primary endpoint, according to Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim.

Sapountzis noted that this achievement represents a significant advancement in the company's ongoing research into IPF, a condition with a high unmet need for effective treatments. Despite the limited data shared this week, the company plans to present comprehensive efficacy and safety data from the trial in early 2025. The recent announcement confirmed that the trial met its primary goal of a better FVC score at 52 weeks than the placebo, although specific figures were not disclosed. Furthermore, information regarding the trial's secondary endpoint, which includes the time to the first occurrence of acute disease exacerbation, hospitalization for respiratory causes, or death, was also not provided.

Nerandomilast, the investigational oral drug being tested, is a preferential inhibitor of phosphodiesterase 4B (PDE4B) and is undergoing another phase 3 trial for progressive fibrosing interstitial lung diseases.

IPF is a degenerative condition marked by the accumulation of scarring and fibrosis in lung tissue, leading to a gradual decline in lung function. It affects between 20-80 people per 100,000 globally, with an average 5-year survival rate of 20-40% after diagnosis.

Currently, two medications are FDA-approved for treating IPF: Ofev (nintedanib), a tyrosine kinase inhibitor developed by Boehringer Ingelheim, and Esbriet (pirfenidone) by Roche, which blocks substances causing fibrosis. Both medications, approved in 2014, have been shown to significantly delay lung function decline and reduce mortality. However, they are seen as temporary solutions, and there remains a substantial need for more effective treatments.

Nerandomilast, previously known as BI1015550, received FDA breakthrough designation in 2022 for treating IPF. This designation is granted to expedite the development of drugs that show significant promise over existing treatments.

Boehringer's approach of targeting PDE4 with Nerandomilast aims to leverage both antifibrotic and anti-inflammatory effects, potentially offering an advantage over currently approved treatments. The company is hopeful that focusing on the PDE4B enzyme subtype, which is predominantly found in the lungs, will help mitigate common adverse effects associated with this class of drugs, such as headaches and gastrointestinal issues.

Other companies are also developing new drugs for IPF, although most candidate therapies are still in phase 2 or earlier stages of development. For example, Vicore Pharma, Bridge Therapeutics, and Pliant Therapeutics all have promising candidates that have reached phase 2 trials. Nonetheless, the successful result of Boehringer Ingelheim's phase 3 trial with Nerandomilast marks a noteworthy advancement in the quest for more effective IPF treatments.