Currently, there are only two FDA-approved drugs for idiopathic pulmonary fibrosis (IPF) — Ofev (nintedanib) from Boehringer Ingelheim and Esbriet (pirfenidone) from Genentech.
Now, Boehringer Ingelheim is announcing the launch of the global FIBRONEER-IPF study focused on BI 1015550, an experimental phosphodiesterase 4B (PDE4B) inhibitor, in idiopathic pulmonary fibrosis (IPF).
The study is part of a broader FIBRONEER program that includes FIBRONEER-ILD for progressive fibrosing interstitial lung diseases.
FDA has granted Orphan Drug Designation to BI 1015550 in IPF.
The prognosis for patients diagnosed with IPF tends to be poor.
Boehringer Ingelheim discovered that the BI 1015550 had anti-fibrotic effects in preclinical and lung fibrosis cellular models.
In the 1990s, Schering helped forge a path for BI 1015550 by developing a selective phosphodiesterase-4 inhibitor known as Rolipram as a possible antidepressant.
Boehringer Ingelheim highlighted the drug in an R&D briefing this year as a promising drug that it intended to commercialize by 2025. The company has invested €25 billion in R&D on the drug.
There are roughly 100,000 people in the U.S. with IPF, according to MedlinePlus. In addition, physicians diagnose approximately 30,000 to 40,000 new cases of the condition annually.
Some 200 lung disorders can ultimately lead to pulmonary fibrosis, which can cause progressively worsening breathing problems for patients with the conditions.
“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 Dr. Donald Zoz, director and senior clinical program leader for pulmonary fibrosis at Boehringer Ingelheim. “As the global market leader, we remain steadfast in our commitment to innovating for people living with pulmonary fibrosis. Enrolling the first patient in our Phase III program is a critical step to help bring forward this next generation of treatment to those in need as quickly as possible,” he said in a news release.
Nintedanib brought in €2.5 billion in revenue in 2021.