Admilparant, an experimental pill from Bristol Myers Squibb (NYSE: BMY), met the main goal of its pivotal Phase 3 trial in idiopathic pulmonary fibrosis (IPF), the company said on October 12, 2026. The admilparant Phase 3 results come with an important asterisk: only the lower of two doses tested, 60 mg, produced a statistically significant benefit on lung function. The higher 120 mg dose slowed decline but missed statistical significance. Here is what the science is, what was actually reported, what remains unknown and what happens next.
Key Points at a Glance
- Verified (company topline): In the ALOFT-IPF trial (about 1,255 adults), admilparant 60 mg twice daily significantly slowed the loss of forced vital capacity (FVC) versus placebo over 52 weeks.
- Verified (company topline): The 120 mg dose slowed FVC decline but the difference versus placebo was not statistically significant.
- Not yet disclosed: The size of the benefit, p-values, secondary endpoints and detailed safety tables.
- Next steps: BMS plans to discuss regulatory submissions with health authorities and present full data at a future medical meeting. A sister trial in progressive pulmonary fibrosis (ALOFT-PPF) is due to read out in early 2027.
What Is Idiopathic Pulmonary Fibrosis?
Pulmonary fibrosis is a chronic disease in which lung tissue becomes progressively scarred and stiff, making it harder to move oxygen into the blood. IPF is the most common progressive form and, as the name “idiopathic” signals, has no identifiable cause.
According to figures cited in BMS’s announcement, about 1.4 million people live with IPF worldwide, median survival after diagnosis is three to five years, and five-year survival is roughly 45%. Existing treatments can slow lung function decline but do not stop or reverse the scarring.
For more than a decade, U.S. patients had two approved antifibrotic drugs, nintedanib and pirfenidone. In October 2025 the FDA approved a third, Boehringer Ingelheim’s nerandomilast (Jascayd), the first new IPF treatment in over ten years. Admilparant would use a different mechanism from all three.
How Admilparant Works: The Science in Plain Language
Admilparant (also known as BMS-986278) is an oral drug that blocks a receptor called LPA1. Lysophosphatidic acid (LPA) is a signaling molecule involved in wound healing. In fibrotic lungs, LPA levels are elevated and LPA1 activation is thought to keep the scarring process switched on.
BMS says that blocking LPA1 targets three drivers of fibrosis at once:
- Faulty repair of the cells lining the lung’s air sacs
- Inflammation and leaky blood vessels
- Activation and spread of fibroblasts, the cells that lay down scar tissue
If approved, admilparant would be a first-in-class LPA1 antagonist. Earlier attempts to drug this pathway by other companies did not succeed, which is part of why this readout has drawn attention.
The ALOFT-IPF Trial: Design and Topline Results
| Item | Detail |
|---|---|
| Trial | ALOFT-IPF (IM027-068, NCT06003426) |
| Design | Phase 3, randomized, double-blind, placebo-controlled, multicenter |
| Participants | About 1,255 adults aged 40+ with IPF |
| Arms (1:1:1) | Admilparant 60 mg, admilparant 120 mg, or placebo, each twice daily for at least 52 weeks |
| Primary endpoint | Absolute change in FVC (mL) from baseline to Week 52 |
| 60 mg result | Statistically significant improvement vs. placebo |
| 120 mg result | Slowed FVC decline; not statistically significant |
| Tolerability | Company says well tolerated; discontinuations due to adverse events low and similar to placebo |
FVC measures how much air a person can forcefully exhale after a full breath. Because IPF steadily erodes FVC, slowing that decline is the standard regulatory benchmark for IPF drugs.
Weighing the Evidence
What the earlier data showed
In a 26-week Phase 2 study published in 2025 in the American Journal of Respiratory and Critical Care Medicine, the 60 mg dose was associated with a 62% relative reduction in the rate of lung function decline in IPF, according to BMS. As HCPLive noted, the confidence interval in that smaller study crossed zero, meaning it was not statistically conclusive on its own. The Phase 3 result at 60 mg is therefore the first statistically significant confirmation in a large, year-long trial.
Open questions
- Magnitude of benefit: BMS has not disclosed how many milliliters of lung function were preserved, which is essential for judging clinical meaningfulness.
- Dose response: Normally a higher dose performs at least as well. Analysts at William Blair, quoted by Fierce Biotech, said “lingering questions on dose response and the magnitude of benefit” remain.
- Liver safety: In early October, Fierce Biotech reported that a protocol amendment described liver toxicity cases in the ALOFT program and one patient death involving acute liver injury. BMS said most liver events were mild and transient. After the readout, William Blair said BMS management indicated the case was in the 120 mg arm and an adjudication committee judged it unlikely related to study treatment. The topline announcement itself did not address liver safety, so full safety data will be closely watched.
Company Statements and Expert Commentary
Company statement: Dr. Cristian Massacesi, BMS’s chief medical officer and head of development, said in the company’s announcement that the data reinforce admilparant’s potential as a clinically meaningful, first-in-class treatment for IPF.
Investigator comment (via BMS release): Dr. Fernando Martinez of UMass Chan Medical School, chair of the ALOFT clinical steering committee, described the results as an important advance given the need for therapies that are both effective and tolerable.
Independent analysis: Until full data are presented and peer-reviewed, the result should be read as a positive but incomplete topline. The 60 mg win, the 120 mg miss and the undisclosed effect size together mean regulators and physicians will be looking closely at the full dataset.
Who Could Benefit?
If approved, admilparant would be aimed at adults with IPF, potentially alone or alongside existing antifibrotics. Because it works through a different pathway, it could in theory be combined with current drugs, though whether that is safe and additive still needs to be shown. People with other progressive fibrosing lung diseases may also benefit if the ALOFT-PPF trial (about 1,057 participants) succeeds.
Admilparant is investigational and not approved by the FDA or any other regulator. Patients interested in clinical trials should talk with their pulmonologist.
What Happens Next
- BMS completes its full analysis of ALOFT-IPF.
- The company engages the FDA and other agencies on planned regulatory submissions (no filing date announced).
- Detailed results are presented at a future medical meeting.
- ALOFT-PPF topline results are expected in early 2027.
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Sources
- Bristol Myers Squibb press release via Business Wire (Oct. 12, 2026)
- HCPLive: ALOFT-IPF admilparant 60 mg meets primary FVC endpoint
- Fierce Biotech: BMS pivotal wins in lung disease and solid tumor
- Fierce Biotech: Patient death in BMS pulmonary fibrosis trial
- FDA: FDA approves drug to treat idiopathic pulmonary fibrosis (nerandomilast)
- ClinicalTrials.gov: NCT06003426
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