First Patient Enrolled in Phase 3 Trial Testing BI 1015550
Potential IPF therapy vetted as part of FIBRONEER global program
Boehringer Ingelheim has enrolled the first patient in FIBRONEER-IPF, a Phase 3 clinical trial evaluating the efficacy, safety, and tolerability of BI 1015550, an investigational therapy for people with idiopathic pulmonary fibrosis (IPF).
The trial is part of the FIBRONEER global program, which also includes FIBRONEER-ILD, a similar Phase 3 study testing the potential therapy in adults with other progressive fibrosing interstitial lung diseases (ILDs).
Both studies are recruiting participants at sites in Florida, Nevada, North Carolina, South Carolina, Oregon, Tennessee, Texas, and Puerto Rico. Contact and site details for FIBRONEER-IPF are available here, and for FIBRONEER-ILD they are here.
“Enrolling the first patient in our Phase 3 program is a critical step to help bring forward this next generation of treatment to those in need as quickly as possible,” Donald Zoz, MD, director and senior clinical program leader for Pulmonary Fibrosis at Boehringer, said in a press release.
IPF is one of more than 200 forms of ILD, all characterized by inflammation and progressive scarring, or fibrosis, in the lungs, making it difficult for patients to breathe. In IPF, the underlying cause of fibrosis is unclear. That’s why it is given the designation “idiopathic,” which means “of unknown cause.”
“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 trial investigator Toby Maher, MD, PhD. Maher is professor of Clinical Medicine at the Keck School of Medicine at the University of Southern California.
BI 1015550 is an orally available treatment designed to suppress the activity of the pro-inflammatory enzyme phosphodiesterase 4B (PDE4B), with the aim of reducing inflammation and fibrosis in IPF and other ILD-related conditions.
Earlier this year, final data from a Phase 2 clinical trial (NCT04419506) demonstrated that BI 1015550 slowed lung function decline in 147 IPF patients, ages 40 and older, regardless of whether they were receiving anti-fibrotic therapies.
“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,” Maher said.
Study design, goals
FIBRONEER-IPF (NCT05321069) is expected to enroll up to 963 IPF patients, ages 40 and older, without exacerbations, or sudden episodes of symptom worsening, in the three months prior. Participants will be assigned randomly to receive either a low or high dose of BI 1015550, or a placebo, twice daily for one year.
The study’s primary goal is to assess changes in lung function after one year, measured by forced vital capacity (FVC) — the maximum amount of air forcibly exhaled from the lungs after a deep breath.
Key secondary measures include evaluating the time to first acute exacerbation, first hospitalization for breathing problems, or death. Investigators also will assess patient-reported outcomes related to shortness of breath, cough, and fatigue.
FIBRONEER-ILD (NCT05321082) aims to enroll up to 1,041 patients, ages 18 and older, diagnosed with progressive fibrosing ILDs other than IPF. The treatment regimen and outcomes are the same as those of FIBRONEER-IPF.
According to Boehringer Ingelheim, the design of both trials was supported by an external advisory committee, with input from patients, caregivers, and healthcare providers.
Early this year, the therapy received breakthrough therapy and orphan drug designations from the U.S. Food and Drug Administration (FDA). Breakthrough therapy designation helps accelerate the clinical development and regulatory review of a new therapy, while orphan drug status is granted to a therapy that aims to prevent, diagnose, or treat a rare disease and provides financial incentives to its developers.
“The FDA’s approval of breakthrough therapy and orphan drug designations for BI 1015550 in idiopathic pulmonary fibrosis reinforces the high unmet need that exists among people living with the devastating impact of this rare disease,” said Zoz. “As the global market leader, we remain steadfast in our commitment to innovating for people living with pulmonary fibrosis.”