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Bristol Myers Squibb Announces Phase 3 ALOFT-IPF Trial Evaluating Admilparant in Adults with Idiopathic Pulmonary Fibrosis Met Primary Endpoint
The study showed a statistically significant progression-free survival benefit and safety consistent with prior data, supporting plans to discuss next steps with regulators.
On Monday, Bristol Myers Squibb announced the Phase 3 ALOFT-IPF trial for admilparant met its primary endpoint, showing statistically significant improvement in preserving lung function for patients with idiopathic pulmonary fibrosis .
Admilparant, a first-in-class LPA1 receptor antagonist, targets irreversible lung scarring in IPF, a fatal disease with median survival time of three to five years following diagnosis.
The 60 mg dose demonstrated statistically significant improvement in forced vital capacity at 52 weeks compared to placebo, while the 120 mg dose failed to show statistical significance.
Bristol Myers plans to engage with regulators regarding the data; Leerink Partners analyst David Risinger wrote the results "could be sufficient to support admilparant regulatory approval," though dose-response questions remain.
Separately, the company reported positive late-stage trial results for RYZ101, a radiopharmaceutical therapy for advanced gastroenteropancreatic neuroendocrine tumors whose disease progressed after prior treatment.