Boehringer Ingelheim has enrolled the first patient in its global phase 3 trial evaluating BI 1015550, an investigational phosphodiesterase 4B inhibitor, in patients with idiopathic pulmonary fibrosis (IPF), the company announced.
The trial – FIBRONEER-IPF – is part of the company’s FIBRONEER global programme, comprising two phase 3 studies in patients with IPF and other progressive fibrosing interstitial lung diseases (ILDs).
In both trials, the primary endpoint is the absolute change from baseline in forced vital capacity (FVC) at week 52, while the key secondary endpoint is the time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF/ILD exacerbation, first hospitalisation for respiratory cause, or death over the duration of the trials.
IPF is one of the more common forms of progressive fibrosing ILDs, with symptoms including breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness.
Dr Donald Zoz, director and senior clinical programme leader for pulmonary fibrosis at Boehringer Ingelheim, said “As the global market leader in pulmonary fibrosis, our ambition is to move beyond slowing down disease progression and one day provide a cure for this devastating condition.
“Enrolling the first patient in our phase 3 programme is a critical step to help bring forward this next generation of treatment to those in need as quickly as possible.”
The late-stage trial follows positive phase 2 trials results for BI 1015550 announced by the company in May this year, with 12-week data demonstrating a reduction in the rate of lung function decline in patients with IPF.
Like FIBRONEER-IPF, the primary endpoint of the trial was the change from baseline in FVC, which it met. The trial also met its secondary endpoint, with BI 1015550 showing acceptable safety and tolerability in IPF patients over 12 weeks.
BI 1015550 was granted Breakthrough Therapy Designation by the US Food and Drug Administration in February 2022.
“New treatments for idiopathic pulmonary fibrosis and other forms of progressive fibrosing interstitial lung diseases are needed to complement existing therapies and to help potentially stop, rather than slow, disease progression,” said the coordinating investigator, Toby Maher, professor of clinical medicine, Keck School of Medicine, University of Southern California, Los Angeles.
“We’re excited to build on the positive phase 2 results so we can better understand the long-term efficacy, safety and tolerability of this investigational medicine.”