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STOCKHOLM, SE / ACCESS Newswire / May 22, 2025 / Vicore Pharma Holding (STO:VICO) - Stockholm, May 22, 2025 - Vicore Pharma Holding AB (STO:VICO), unlocking the potential of a novel class of drugs, angiotensin II type 2 receptor agonists (ATRAGs), today announced that the company delivered multiple oral presentations and posters this week at the 2025 American Thoracic Society (ATS) International Conference, held May 16-21, 2025.
"The presentations at this year's ATS conference underscore the momentum building around our innovative approach to the treatment of idiopathic pulmonary fibrosis (IPF)," said Bertil Lindmark, MD, PhD, Chief Medical Officer of Vicore. "We are proud to share compelling new data that highlight the potential of buloxibutid to address critical unmet needs and offer a differentiated, disease-modifying therapy for patients suffering from IPF."
The AIR Phase 2 Trial of the Angiotensin II Type 2 Receptor Agonist, Buloxibutid, in Individuals With Idiopathic Pulmonary Fibrosis: A Responder Analysis
In an oral presentation, Toby Maher, MD, PhD, provided further detail from the Phase 2a AIR trial evaluating buloxibutid in IPF, including an analysis of the response pattern in percent predicted forced vital capacity (ppFVC) and a Synthetic Control Arm (SCA) analysis utilizing real world data from a large cohort of IPF patients.
A key finding in the Phase 2a AIR trial was that a substantial proportion of participants demonstrated improvement in lung function. An analysis comparing the proportion of patients experiencing improvement in lung function at 0, 5 and 10 ppFVC in the Phase 2a AIR trial with the Phase 3 studies leading to the approval of the current standard of care compared favorably with those for the approved antifibrotic agents.
In addition to the responder analysis, Dr. Maher presented a SCA drawn from a pool of over 10,000 real world IPF patients on the Qureight platform and tightly matched to the Phase 2a AIR population using a Monte Carlo cross validation analysis. Comparison of forced vital capacity (FVC) in these SCAs to the impact of buloxibutid on FVC in the Phase 2a AIR trial revealed a robust treatment effect with a high degree of statistical significance (p=.0025).
Buloxibutid Potently Inhibits Fibrosis Biomarkers in the Scar-in-a-Jar Primary Human Lung Fibroblast Assay
In a human lung fibroblast assay, buloxibutid demonstrated potent and dose-dependent inhibition of PRO-C3 a key biomarker reflecting fibrotic progression, at concentrations reached systemically with clinical doses of the drug candidate. In comparison, clinically relevant concentrations of nintedanib did not inhibit PRO-C3 and nerandomilast showed limited impact on PRO-C3 across all tested concentrations, including concentrations in the clinically relevant range. The superior in vitro performance of buloxibutid compared to nintedanib and nerandomilast on IPF biomarkers associated with fibrotic progression highlights robust anti-fibrotic activity and positions it as a competitive next-generation IPF therapy.