• 18 Sep 2024
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• News Article

Boehringer Ingelheim Pivotal Phase-III FIBRONEER-IPF Study Meets Primary Endpoint

Boehringer Ingelheim pivotal phase-III FIBRONEER-IPF study of nerandomilast meets primary endpoint

Overview

Boehringer Ingelheim announced that the FIBRONEER-IPF trial met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] (FVC) at week 52 versus placebo. FVC is a measure of lung function.

Post Result Proceedings

Based on these results, Boehringer Ingelheim will submit the new drug application for nerandomilast for the treatment of IPF to the US Food & Drug Administration (FDA) and other Health Authorities worldwide. The FDA granted Breakthrough Therapy Designation in IPF in 2022.

Statement from Boehringer Ingelheim

• “This is the first IPF phase-III-trial in a decade to meet its primary endpoint,” said Ioannis Sapountzis, head of global therapeutic areas at Boehringer Ingelheim.  
• “Today’s announcement represents the next step in our long history in the research of this disease. IPF has a high unmet need for patients, and we are continuously fostering our research activities to develop more options for one of the most common interstitial lung diseases.”

Nerandomilast Under Trial

• Nerandomilast is an oral, investigational phosphodiesterase 4B (PDE4B) inhibitor and has not been approved for use, therefore safety and efficacy have not been established. 
• It is being investigated as part of the FIBRONEER global programme, which includes two phase III studies —FIBRONEER-IPF4 in patients with IPF and FIBRONEER-ILD5 in people living with progressive pulmonary fibrosis (PPF).

About the Trial

A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 52 weeks in patients with idiopathic pulmonary fibrosis (IPF).

Primary Endpoint: 
Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52.

Secondary Endpoint
Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation; first hospitalization for respiratory cause; or death (whichever occurs first) over the duration of the trial.

Trial Procedure

• Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of nerandomilast as tablets twice a day. 
• Participants in the placebo group take placebo tablets twice a day. 
• Placebo tablets look like nerandomilast tablets but do not contain any medicine.
• The trial has been conducted in more than 30 countries, and randomized 1177 patients.

FIBRONEER Programme

• The FIBRONEER programme includes two Phase III randomized, double-blind, placebo-controlled trials — FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082) — to investigate the efficacy, safety and tolerability of nerandomilast over at least 52 weeks in patients with IPF and in patients with PPF.
• Patients participating in the FIBRONEER-IPF trial were treated with either oral nerandomilast at twice-daily doses of 9 mg or 18 mg, or placebo, over at least 52 weeks.1 The 18 mg twice-daily dose of nerandomilast is supported by the results from the phase II study. 
• An additional 9 mg twice-daily dose of nerandomilast was added to evaluate the benefit-risk profile at a lower dose, as well as to provide further dose-response and exposure-response data.

Primary Endpoint in Both Trials

• In both trials, the primary endpoint is the absolute change from baseline in FVC at week 52. 
• 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/PPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trials.

All About Nerandomilast

• Nerandomilast (BI 1015550) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). 
• This compound is an investigational agent and has not been approved for use. The efficacy and safety of this investigational compound has not been established.
• Nerandomilast was granted FDA Breakthrough Therapy Designation for the treatment of idiopathic pulmonary fibrosis (IPF) in February 2022.

Safety Profile

• The efficacy, safety, and tolerability of nerandomilast was studied in a phase II randomized, double-blind, placebo-controlled trial of patients with IPF (n=147). 
• The primary endpoint was a change from baseline in FVC (a measure of lung function) over a 12-week treatment period.

About IPF

• IPF is one of the more common progressive fibrosing interstitial lung diseases (ILD). 
• Symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. 
• Although considered “rare,” IPF affects approximately 3 million people worldwide. 
• The disease primarily affects patients over the age of 50 and affects more men than women.

In addition to IPF, patients with certain types of fibrosing ILD may develop a progressive phenotype known as progressive pulmonary fibrosis (PPF). In ILDs other than IPF, progressive pulmonary fibrosis is defined by worsening respiratory symptoms, physiological evidence of disease progression and radiological evidence of disease progression.

About the Company

• Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. 
• As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need.