Oral therapy slows lung function decline in IPF, trial data show

Admilparant, an experimental oral therapy being developed by Bristol Myers Squibb, slowed lung function declines among people with idiopathic pulmonary fibrosis (IPF) in a Phase 3 clinical trial.

The study, ALOFT-IPF (NCT06003426), enrolled approximately 1,255 adults with IPF ages 40 and older. The trial was open to patients currently taking the drug or who have recently taken the approved therapies pirfenidone (sold as Esbriet and available as generics) or nintedanib (sold as Ofev and available as generics).

Participants were randomly assigned to take one of two doses of admilparant — 60 or 120 mg, twice daily — or a placebo. The study’s main goal was to see if admilparant slowed the decline in forced vital capacity (FVC), a standard measure of lung function based on how much air someone can blow out in a large breath.

According to a company press release, the study met its goal: After one year, the decline in FVC was slower among patients given the lower dose of admilparant compared with those given the placebo. This difference was statistically significant, meaning that mathematically it’s extremely unlikely the difference is due to random chance.

Patients given the higher admilparant dose also generally had less FVC decline than those given the placebo, according to the company. However, the difference was not statistically significant, meaning the likelihood that the difference is due to random chance is non-negligible).

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‘Important advancement’ for patients

Admilparant showed a well-tolerated safety profile across both tested doses. The company noted that discontinuations due to safety issues were rare and happened at similar rates among patients given the active therapy and those taking the placebo.

Bristol Myers Squibb didn’t provide details on the trial results, noting that in-depth findings will be presented at a future medical conference and that it will with engage with health authorities regarding regulatory submissions for treatment approval.

“These admilparant results represent an important advancement as there remains a need for therapies that are both effective and tolerable for patients living with IPF,” said Fernando Martinez, MD, chair of the ALOFT program clinical steering committee at the University of Massachusetts Chan Medical School.

IPF is a disorder marked by fibrosis (scarring) in the lungs. This scarring tends to worsen over time, driving progressive worsening of lung function.

“IPF remains one of the most complex and challenging lung diseases to treat, with unpredictable progression, irreversible scarring and a profound impact on patients’ daily lives,” Martinez said.

Lysophosphatidic acid (LPA), a signaling molecule, is thought to contribute to fibrosis in IPF. Admilparant is designed as an antagonist (blocker) of a key receptor for this signaling molecule, LPA1. By blocking this receptor, the therapy aims to blunt LPA’s effects and ultimately reducing fibrosis.

Cristian Massacesi, MD, executive vice president, chief medical officer and head of development at Bristol Myers Squibb, said the top-line results from the ALOFT-IPF study “reinforce the profile of admilparant as a promising, clinically meaningful investigational therapy for IPF – one that reflects the innovation of targeting the LPA1 pathway as a first-in-class approach.”

IPF is characterized by fibrosis in which the underlying cause is unknown. Bristol Myers Squibb is also developing admilparant as a treatment for progressive pulmonary fibrosis (PPF), which is marked by gradually worsening lung scarring due to other established lung disorders. A Phase 3 trial in PPF,  ALOFT-PPF (NCT06025578), is ongoing, with results expected in 2027.

“We also look forward to sharing the topline results from the ALOFT-PPF trial early next year, as we continue working to improve outcomes for patients with pulmonary fibrosis,” Massacesi said.