Nerandomilast Phase 3 clinical trial meets its primary goal in IPF
Therapy bested placebo at improving lung function, preventing declines
A Phase 3 clinical trial testing Boehringer Ingelheim’s oral investigational treatment nerandomilast in people with idiopathic pulmonary fibrosis (IPF) has met its primary goal of demonstrating the therapy outperformed a placebo at improving lung function or preventing its decline after a year, recently announced top-line data shows.
FIBRONEER-IPF (NCT05321069) enrolled 1,177 patients, ages 40 and older, at several sites in the U.S., Canada, South America, Europe, Asia, and Australia. Full efficacy and safety data will be presented in the first half of 2025. The company intends to seek the nerandomilast’s approval for IPF to the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide.
“This is the first IPF phase-III-trial in a decade to meet its primary endpoint,” Ioannis Sapountzis, PhD, head of global therapeutic areas at Boehringer, said in a company press release. “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.”
IPF is a type of interstitial lung disease (ILD), a group of diseases wherein inflammation and progressive scarring, or fibrosis, in the lungs make it difficult for patients to breathe. The specific underlying cause of fibrosis in IPF is unclear.
What is nerandomilast?
Nerandomilast, also called BI 1015550, is designed to block the activity of phosphodiesterase 4B (PDE4B), a pro-inflammatory enzyme involved in fibrosis. This should reduce inflammation and scarring in IPF and other types of ILD.
In FIBRONEER-IPF, patients were randomly assigned to one of two doses of nerandomilast (9 or 18 mg), or a placebo, twice daily, for at least a year. Changes in lung function were assessed via forced vital capacity (FVC), the maximum amount of air patients can forcibly exhale after a deep breath.
Secondary efficacy measures included the time to the first occurrence of an acute disease exacerbation, hospitalization due to breathing problems, or death. The trial is also assessing patient-reported outcomes related to shortness of breath, cough, and fatigue.
In a previous Phase 2 clinical trial (NCT04419506), nerandomilast slowed lung function decline in adults with IPF when given at 18 mg twice daily for three months, regardless of whether they were on anti-fibrotic therapies.
Boehringer is also testing nerandomilast in a Phase 3 trial (NCT05321082) enrolling 1,178 adults, ages 18 and older, with progressive fibrosing ILDs other than IPF. Patients are receiving the same treatment regimen and its efficacy is being assessed using the same measures.
Nerandomilast has received both breakthrough therapy and orphan drug designations from the FDA. These designations are meant to accelerate the clinical development and regulatory review of new therapies intended to treat serious and rare conditions.
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