German pharmaceutical giant Boehringer Ingelheim (BI) has announced the first patient enrollments in the Phase III FIBRONEER studies for its phosphodiesterase 4b (PDE4B) inhibitor, BI 1015550. The studies are focused on idiopathic pulmonary fibrosis (IPF) and progressive fibrosis interstitial lung disease (PF-ILD), two conditions with limited treatment options.
Global Study Design and Scope
The FIBRONEER study is designed to evaluate the effectiveness and safety of BI 1015550 in treating IPF/PF-ILD patients for at least 52 weeks. The trial will be conducted in over 40 countries worldwide, with 44 clinical trial centers participating in China. The IPF trial is expected to enroll 135 patients in China, and the PF-ILD trial will enroll 149 patients. Participants will be randomly assigned to either 9 mg bid or 18 mg bid drug treatment groups, as well as a placebo group. The primary endpoint is the absolute change in forced vital capacity (FVC) from baseline at week 52, while the key secondary endpoint is the time between the trial period and the first occurrence of any of the following composite endpoint events: the first acute exacerbation of IPF/ILD, the first hospitalization for respiratory system reasons, or death. The safety and tolerability of BI 1015550 will also be evaluated.
Understanding Interstitial Lung Disease and PDE4’s Role
Interstitial lung disease (ILD) is a complex and poorly understood lung disease, primarily involving the pulmonary interstitium, alveoli, and/or bronchioles. IPF and PF-ILD are relatively common progressive fibrosis ILDs. Phosphodiesterase 4 (PDE4) can regulate proinflammatory pathways and mediate the production of anti-inflammatory cytokines by specifically hydrolyzing cAMP, making it an important therapeutic target for inflammatory diseases. As a selective inhibitor of the PDE4B subtype, BI 1015550 is expected to play a significant anti-fibrosis and anti-inflammatory role in patients with IPF/ILD.-Fineline Info & Tech
