Bristol Myers' admilparant meets Phase 3 IPF goal at 60 mg but misses at 120 mg

Bristol Myers Squibb said on 12 October 2026 that its oral LPA1 antagonist admilparant met the primary endpoint of ALOFT-IPF, a Phase 3 trial in idiopathic pulmonary fibrosis, but only at the lower of the two doses tested ¹². The company plans to analyse the data with a view to filing with regulators in several countries in the coming months ².

What the trial found

ALOFT-IPF tested admilparant at 60 mg and 120 mg twice daily against placebo for 52 weeks in adults with IPF ². The endpoint was the absolute change from baseline in forced vital capacity (FVC), the volume of air a person can breathe out in one go ¹². At 60 mg the drug produced a statistically significant improvement over placebo at one year ². At 120 mg Bristol Myers reported an effect on disease progression, but it fell short of statistical significance ¹.

Discontinuations did not differ between either dose and placebo, so poor tolerability does not appear to explain the weaker high-dose result ². Bristol Myers described the drug as having "demonstrated a well-tolerated safety profile" ¹. That matters because the company had earlier revised safety monitoring in the European part of the study, which raised liver-related concerns among analysts and investors ¹. Detailed results have not yet been released ¹.

IPF affects about 1.4 million people worldwide, and median survival after diagnosis is three to five years ².

What it means for the market

The readout puts Bristol Myers in position to bring the first LPA1 antagonist to market ². Earlier efforts in the class struggled: Bristol Myers dropped one candidate over liver toxicity, and Amgen ended work on another after a Phase 2 miss ¹. The current standard therapies are Boehringer Ingelheim's Ofev and Roche's Esbriet, both of which offer limited slowing of disease and difficult side effects ². Ofev brought Boehringer €3.8 billion in sales last year, and Esbriet passed €1 billion at its peak before losing patent protection ². Boehringer's PDE4B inhibitor Jascayd was approved last year, the first new IPF drug in about a decade ².

The missing dose response is the main point of contention. Leerink Partners analyst David Risinger wrote that the data "could be sufficient to support admilparant regulatory approval, but the lack of dose response raises questions" about the drug's profile ¹. RBC Capital Markets analyst Trung Huynh called the high-dose failure "confounding and requires further explanation" ¹. William Blair analyst Matt Phipps took a more positive view, writing that success at the lower dose is "likely to open a blockbuster opportunity" ¹.

Investors reacted cautiously. Bristol Myers shares rose more than 6% before trading opened and then turned to a loss of about 4% ¹. Contineum Therapeutics, which has a different LPA1 drug in Phase 2, saw its shares fall about 30% on Monday morning ¹. The same day, Bristol Myers also reported a successful late-stage study of RYZ-101, a radiopharmaceutical for certain neuroendocrine tumours that it acquired through its $4.1 billion buyout of RayzeBio ¹.

Caveats

The results so far are topline only, and analysts said they need the full data to judge the size of the benefit ¹. The lack of a better response at 120 mg is not yet explained ¹. Bristol Myers is also running a second Phase 3 trial, ALOFT-PPF, in progressive pulmonary fibrosis, with results due next year ².