Bristol Myers Squibb (BMS) has received breakthrough therapy designation from the US Food and Drug Administration for its investigational therapy BMS-986278 to treat progressive pulmonary fibrosis (PPF).
The potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist BMS-986278 is being evaluated as a new antifibrotic therapy for PPF and idiopathic pulmonary fibrosis (IPF).
The FDA granted the designation based on data obtained from the international randomised Phase II clinical trial of BMS-986278.
The study evaluated the efficacy and safety of the therapy against placebo for IPF and PPF.
It included parallel cohorts of IPF and PPF patients who received 30mg or 60mg of BMS-986278 or matched placebo orally twice a day.
Data from the PPF cohort demonstrated that subjects who received a twice-daily 60mg dose for 26 weeks reported a relative reduction of 69% in the rate of decline in predicted forced vital capacity against placebo.
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BMS immunology, cardiovascular and neuroscience development senior vice-president and head Roland Chen stated: “People living with pulmonary fibrosis face deteriorating lung function, worsening respiratory symptoms and reduced quality of life, which can ultimately lead to respiratory failure and death.
“The FDA’s breakthrough therapy designation underscores the potential of BMS-986278 as an innovative, first-in-class treatment that may redefine the standard of care for progressive pulmonary fibrosis.”
BMS-986278 previously received fast-track designation and orphan drug designation from the FDA to treat IPF.
In mid-October 2023, the FDA granted approval for BMS’ Opdivo (nivolumab) to treat stage IIB or IIC melanoma patients who have undergone complete resection.