Admilparant meets primary endpoint at 60 mg dose in Phase 3 ALOFT-IPF trial for idiopathic pulmonary fibrosis

Bristol Myers Squibb has reported topline results from the pivotal Phase 3 ALOFT-IPF trial of admilparant, a potential first in class, orally administered and selective lysophosphatidic acid receptor 1 (LPA1) antagonist, in adults with idiopathic pulmonary fibrosis (IPF). The trial tested two doses, 60 mg and 120 mg, taken twice daily for at least 52 weeks and compared each with placebo, with patients split evenly across the three groups.

At the 60 mg dose, admilparant met the primary endpoint, producing a statistically significant improvement over placebo in the absolute change in forced vital capacity (FVC) from baseline to Week 52. At 120 mg, admilparant slowed the decline in FVC, but the difference was not statistically significant.

The drug was well tolerated at both doses. Discontinuations because of adverse events were low in both admilparant arms and similar to placebo.

Cristian Massacesi, MD, executive vice president, chief medical officer and head of development at Bristol Myers Squibb, said the topline data reinforce admilparant’s profile as a promising and clinically meaningful investigational therapy for IPF, reflecting the innovation of targeting the LPA1 pathway as a first in class approach. He said the company expects to share topline results from the ALOFT-PPF trial early next year as it continues working to improve outcomes for people with pulmonary fibrosis.

Fernando Martinez, MD, chair of the ALOFT programme clinical steering committee and interim chair and professor of medicine at UMass Chan Medical School, said IPF remains one of the most complex and difficult lung diseases to treat, marked by unpredictable progression, irreversible scarring and a profound effect on daily life. He said the admilparant results are an important advance, given the continuing need for therapies that are both effective and tolerable.

Bristol Myers Squibb will complete a full evaluation of the ALOFT-IPF data and engage with health authorities to support planned regulatory submissions. Detailed results will be presented at a future medical meeting. Admilparant is also being studied in the fully enrolled Phase 3 ALOFT-PPF trial in progressive pulmonary fibrosis, with topline results expected in early 2027.

The company thanked the patients and investigators who took part in ALOFT-IPF.

About pulmonary fibrosis

Pulmonary fibrosis is a chronic, life threatening interstitial lung disease in which lung tissue becomes irreversibly damaged and scarred, affecting how the lungs work. IPF is the most common type of progressive fibrosing interstitial lung disease. Its cause cannot be identified, and about 1.4 million people live with it worldwide. Progressive pulmonary fibrosis describes non idiopathic forms of the condition, including connective tissue disease related lung diseases such as rheumatoid arthritis associated and scleroderma associated interstitial lung disease, and other types such as environmental lung fibrosis caused by exposure to dust or chemicals.

Many people with pulmonary fibrosis are physically impaired and experience a steady decline in lung function. Breathlessness and chronic cough make simple daily activities hard, and some need continuous supplemental oxygen to breathe more easily.

The disease is fatal, with a median survival of three to five years after diagnosis and a five year survival rate of about 45 per cent. Few new treatments have been approved in more than a decade. Current therapies can slow the decline in lung function, but there is still a need for additional safe and tolerable options that let patients manage their disease while carrying on with daily activities.

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Related Topics and Keywords

Admilparant, idiopathic pulmonary fibrosis, Phase 3 ALOFT-IPF trial