Tuesday, April 16, 2024

Breakthrough Therapy Designation Granted to Potential Pulmonary Fibrosis Treatment

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Bristol Myers Squibb (BMS) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational drug, BMS-986278, which is an oral lysophosphatidic acid receptor 1 (LPA1) antagonist. The designation is for the treatment of progressive pulmonary fibrosis (PPF), a severe and life-threatening condition with limited treatment options.

Currently, only one therapy is approved for PPF treatment. However, BMS-986278 has shown promise in a global Phase 2 study involving individuals with idiopathic pulmonary fibrosis (IPF) and PPF. The study revealed that a 60 mg twice-daily dose of BMS-986278 resulted in a 69% reduction in the rate of decline in forced vital capacity over 26 weeks compared to a placebo. Importantly, the drug was well-tolerated, with adverse events similar to those in the placebo group.

Breakthrough Therapy Designation is designed to expedite the development and review of medications for serious or life-threatening diseases when there is preliminary clinical evidence suggesting significant improvement compared to existing treatments.

Pulmonary fibrosis, whether idiopathic or progressive, leads to lung tissue damage and scarring, severely affecting lung function. There is a pressing need for new therapies to address this condition, which often leads to respiratory failure and death.

BMS-986278 was previously granted fast-track and orphan drug designations by the FDA for the treatment of IPF. The company is currently advancing its development with a global Phase 3 ALOFT program for both PPF and IPF.

The Breakthrough Therapy Designation underscores the potential of BMS-986278 to redefine the standard of care for individuals suffering from progressive pulmonary fibrosis, offering hope for improved quality of life and survival.

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