Hope is on the horizon – Boehringer Ingelheim has reported a significant milestone in its ongoing research for idiopathic pulmonary fibrosis (IPF) with their drug Nerandomilast successfully achieving its primary endpoint in the pivotal Phase-III FIBRONEER™-IPF trial.
The primary endpoint focused on the change in Forced Vital Capacity (FVC), a measure of lung function, after 52 weeks compared to a placebo. This is a major achievement as it is the first Phase-III trial for IPF in over a decade to meet its primary endpoint, highlighting Nerandomilast’s potential as a promising treatment option.
The FIBRONEER™-IPF trial was the largest ever conducted for IPF, involving 1,177 patients across over 330 sites in more than 30 countries. As an investigational oral drug (previously known as BI1015550), Nerandomilast works by inhibiting phosphodiesterase 4B (PDE4B), which plays a role in inflammatory processes within the lungs.
Although it has not yet been approved for use, the drug’s success in this trial could pave the way for regulatory approval, with Boehringer Ingelheim planning to submit applications to the FDA and global health authorities.
The full report from the FIBRONEER™-IPF trial will be shared in the first half of 2025 and we can’t wait to see the results.
For more information, visit here.
[Posted 18.9.24]
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