Vicore Presents New Data at the 2025 American Thoracic Society International Conference
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.
ASPIRE Trial in Idiopathic Pulmonary Fibrosis: A Patient Experience-focused Phase 2b Randomized, Double-blind, Placebo-controlled, Multicenter Trial of the Novel Angiotensin II Type 2 Receptor Agonist Buloxibutid
Tamera Corte, MD, PhD, presented the design of the Phase 2b ASPIRE trial evaluating the efficacy and safety of buloxibutid in IPF and highlighted its patient-friendly features. ASPIRE is currently ongoing in fourteen countries. To improve patient participation and retention, a patient and caregiver panel consisting of six IPF patients and two caregivers was established during the trial design process. The panel provided feedback and advised on the ASPIRE trial design, trial conduct, and patient-facing materials. The panel assisted in optimizing the trial design by suggesting fewer site visits and supplementing essential in-person visits with telephone visits to ensure patient safety and promote engagement. In addition, semi-structured interviews were added during the trial with a subgroup of 10-14 participants to provide feedback on the trial participation experience. This feedback played a critical role in shaping the design of the Phase 2b ASPIRE trial to prioritize patient experience while maintaining scientific rigor.
A Digital Psychological Therapy Improves Health-related Quality of Life in Pulmonary Fibrosis Patients Using Antifibrotic Treatment
In an oral presentation, Joshua Solomon, MD, provided an overview of the COMPANION trial, a randomized, controlled, open-label trial investigating the efficacy of the digital therapeutic, Almee TM , in patients with pulmonary fibrosis and anxiety symptoms. Treatment with Almee, the first pulmonary fibrosis-specific digital psychotherapy, significantly improved psychological health, as reflected in Health-Related Quality of Life scores, in participants with pulmonary fibrosis, whether taking antifibrotic treatment or not.
For further information, please contact:
Megan Richards, VP of IR, Communications, and Portfolio Strategy, tel: +1 978 269-4372, megan.richards@vicorepharma.com
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com
About Vicore Pharma
Vicore Pharma Holding AB is a clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential in respiratory and fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). The company 's lead program, buloxibutid (C21), is a first-in-class oral small molecule angiotensin II type 2 (AT2) receptor agonist, which has received Orphan Drug and Fast Track designation from the United States Food and Drug Administration and is currently being investigated in the global 52-week Phase 2b ASPIRE trial in IPF.
The company is publicly listed on the Nasdaq Stockholm exchange (VICO).www.vicorepharma.com
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Vicore Presents New Data at the 2025 American Thoracic Society International Conference
SOURCE: Vicore Pharma Holding
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