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Vicore Pharma Holding AB unveiled positive final results from its phase 2a AIR trial evaluating buloxibutid (C21) in idiopathic pulmonary fibrosis (IPF) at the American Thoracic Society (ATS) International Congress. The trial assessed buloxibutid (100 mg orally twice daily) in treatment-naïve IPF patients over 36 weeks.
Results showed significant improvement in lung function, measured by forced vital capacity (FVC), surpassing the untreated decline trajectory by approximately 400 mL (n=28, p<0.001). Buloxibutid exhibited good safety and tolerability, with no drug-related serious adverse events and positive patient benefit/risk assessment (97% at weeks 12 and 24).
Plasma levels of collagenase MMP-13 rose, while profibrotic cytokine TGF-1 decreased, aligning with buloxibutid's mechanism of action. These outcomes support advancing to the phase 2b ASPIRE trial, a randomized, double-blind, placebo-controlled study. IPF, a fatal fibrotic lung disease, primarily affects older adults, with a life expectancy of 3-5 years post-diagnosis. The RAS, regulating essential physiological processes, includes the AT1 receptor targeted by ARBs for hypertension.
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