Bristol Myers Squibb (BMS) announced positive topline results from the Phase 3 ALOFT-IPF trial evaluating admilparant, an investigational oral lysophosphatidic acid receptor 1 (LPA1) antagonist, in adults with idiopathic pulmonary fibrosis (IPF). The 60 mg twice-daily dose met the trial’s primary endpoint, demonstrating a statistically significant improvement in forced vital capacity (FVC) compared with placebo at Week 52.
Key Highlights from the ALOFT-IPF Trial
-
Primary endpoint achieved: Admilparant 60 mg twice daily demonstrated a statistically significant improvement in the absolute change in FVC from baseline at Week 52 compared with placebo.
-
Results at the higher dose: The 120 mg twice-daily dose slowed the decline in FVC but did not achieve statistical significance.
-
Safety and tolerability: Both doses demonstrated a well-tolerated safety profile, with low rates of treatment discontinuation due to adverse events, comparable to placebo.
-
Trial design: The Phase 3 study compared two doses of admilparant (60 mg and 120 mg, twice daily) with placebo over at least 52 weeks.
-
Patient participation: The ALOFT-IPF trial enrolled approximately 1,255 adults with IPF.
Bristol Myers Squibb Plans Regulatory Discussions
Bristol Myers Squibb will conduct a comprehensive analysis of the ALOFT-IPF trial data and engage with health authorities to support planned regulatory submissions. Detailed findings are expected to be presented at a future medical meeting.
Cristian Massacesi, MD, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb, said the results support admilparant’s potential as an investigational treatment for IPF and highlight the approach of targeting the LPA1 pathway.
Fernando Martinez, MD, Chair of the ALOFT program clinical steering committee and professor of medicine at UMass Chan Medical School, noted that IPF remains a challenging disease to treat, emphasizing the need for additional therapies that combine efficacy with tolerability.
ALOFT-PPF Trial Results Expected in Early 2027
Admilparant is also being evaluated in the fully enrolled Phase
