Vicore Pharma presented compelling new data for its investigational idiopathic pulmonary fibrosis (IPF) treatment, buloxibutid, at the 2025 American Thoracic Society (ATS) International Conference held May 16-21. The data showcased significant improvements in lung function and superior anti-fibrotic activity compared to existing treatments.
Dr. Toby Maher presented an in-depth analysis of the Phase 2a AIR trial, highlighting that a substantial proportion of participants experienced improvement in lung function when treated with buloxibutid. The responder analysis compared favorably to Phase 3 studies of currently approved antifibrotic agents.
"The presentations at this year's ATS conference underscore the momentum building around our innovative approach to the treatment of idiopathic pulmonary fibrosis," 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."
Superior Anti-Fibrotic Activity Demonstrated in Laboratory Studies
In a key laboratory study using human lung fibroblasts, buloxibutid showed potent and dose-dependent inhibition of PRO-C3, an important biomarker reflecting fibrotic progression. This inhibition occurred at concentrations achievable with clinical doses of the drug candidate.
The comparative analysis revealed that clinically relevant concentrations of nintedanib, a current standard treatment, did not inhibit PRO-C3. Similarly, nerandomilast showed limited impact on this fibrosis biomarker across all tested concentrations, including those in the clinically relevant range.
These findings position buloxibutid as a potentially more effective next-generation therapy for IPF, with robust anti-fibrotic activity that exceeds current treatment options.
Synthetic Control Arm Analysis Shows Significant Treatment Effect
The Phase 2a AIR trial data was further validated through a Synthetic Control Arm (SCA) analysis. This innovative approach utilized real-world data from over 10,000 IPF patients on the Qureight platform, carefully matched to the Phase 2a AIR population using Monte Carlo cross-validation analysis.
When comparing forced vital capacity (FVC) between the synthetic control arm and buloxibutid-treated patients, researchers observed a robust treatment effect with high statistical significance (p=0.0025). This analysis provides additional evidence supporting buloxibutid's potential efficacy in treating IPF.
Patient-Centered Approach in Ongoing Phase 2b ASPIRE Trial
Dr. Tamera Corte presented the design of the ongoing Phase 2b ASPIRE trial, which is currently being conducted in fourteen countries. The trial incorporates several patient-friendly features developed with input from a panel of six IPF patients and two caregivers.
Based on this feedback, the trial design was optimized to reduce the burden on participants by decreasing the number of required site visits and supplementing essential in-person visits with telephone consultations. This approach aims to improve patient participation and retention while maintaining scientific rigor.
Additionally, the trial includes semi-structured interviews with a subgroup of 10-14 participants to gather feedback on the trial participation experience, further emphasizing Vicore's commitment to patient-centered research.
Digital Therapeutic Shows Promise for Quality of Life Improvement
Dr. Joshua Solomon presented results from the COMPANION trial, which investigated the efficacy of Almee, a digital therapeutic developed specifically for pulmonary fibrosis patients with anxiety symptoms.
The randomized, controlled, open-label trial demonstrated that treatment with Almee significantly improved psychological health and Health-Related Quality of Life scores in participants with pulmonary fibrosis, regardless of whether they were taking antifibrotic treatment.
As the first pulmonary fibrosis-specific digital psychotherapy, Almee represents an important advancement in addressing the psychological aspects of living with this challenging condition.
About Buloxibutid and Vicore Pharma
Buloxibutid (C21) is a first-in-class oral small molecule angiotensin II type 2 receptor agonist (ATRAG) being developed for the treatment of IPF. The drug candidate has received both Orphan Drug and Fast Track designation from the U.S. Food and Drug Administration.
Vicore Pharma Holding AB is a clinical-stage pharmaceutical company focused on developing novel treatments for respiratory and fibrotic diseases. The company is publicly listed on the Nasdaq Stockholm exchange and continues to advance its pipeline of innovative therapies aimed at addressing significant unmet medical needs.
