IPF Drug Meets Primary End Point

Boehringer Ingelheim announced today that its nerandomilast, its novel treatment drug for idiopathic pulmonary fibrosis (IPF), meet its primary endpoint in a pivotal phase 3 trial.

In recent years, several promising treatments for IPF have faltered in late-stage trials, so the currently approved treatment drugs are limited to Ofev (nintedanib) and Esbriet (pirfenidone), both of which have problematic side effect profiles. Because of the dearth of new treatments in recent years, approval of a new drug would be an especially significant development for people IPF, their loved ones and the clinicians who take care of them.

“This is the first IPF phase-3 trial in a decade to meet its primary end point” Ioannis Sapountzis, head of global therapeutic areas at Boehringer Ingelheim, a German company, said in a news release. “Today’s announcement represents the next step in our long history in the research of this disease.”

Nerandomilast, an oral drug, is a preferential inhibitor of phosphodiesterase 4B, an enzyme that is believed to play a central role in inflammatory processes. It was given FDA breakthrough therapy designation in February 2022. Boehringer Ingelheim said in today’s news release that the positive results will mean that it will submit a new drug application for nerandomilast with the FDA and other countries’ drug regulators.

Participants in the FIBRONEER-IPF trial randomly assigned 1,177 people with IPF to one of three group: those who took a placebo and those who took either a 9 milligram or an 18 milligram dose of nerandomilast. The placebo and the nerandomilast doses were given twice a day as pills. The trial has been conducted in more than 30 countries.

Today’s new release provided limited information about the FIBRONEER-IPF results. Full efficacy and safety data from the trial will be presented in the first half of next year, according to the news release.