Vicore Reports Positive Phase 2a AIR Trial Results: Buloxibutid Enhances Lung Function in Idiopathic Pulmonary Fibrosis

Vicore Pharma Holding AB (STO: VICO), a clinical-stage biopharmaceutical company, has announced promising results from its Phase 2a AIR trial, which evaluated the effectiveness of buloxibutid (C21) in treating idiopathic pulmonary fibrosis (IPF). The results were presented at the American Thoracic Society (ATS) International Congress on May 19th, 2024.

The AIR trial focused on assessing buloxibutid, an angiotensin II type 2 receptor agonist (ATRAG), administered at 100 mg orally twice daily for up to 36 weeks in treatment-naïve IPF patients. This multicenter, open-label, single-arm study demonstrated positive outcomes for both its primary and secondary endpoints, including marked improvements in lung function, safety, and tolerability.

One of the standout findings was the significant improvement in lung function, measured by forced vital capacity (FVC). Over the 36-week period, patients in the AIR trial exhibited an average FVC increase of 216 mL from baseline to week 36. This represents nearly a 400 mL improvement over the expected decline observed in untreated patients, who typically experience a reduction of about 180 mL over the same period. The FVC improvement was consistent across all subgroups analyzed, including variations in geography, gender, and radiologic patterns.

Safety and tolerability were also thoroughly assessed, with buloxibutid showing no drug-related serious adverse events and good gastrointestinal (GI) tolerability. At both the 12-week and 24-week marks, medical evaluations were conducted to determine the benefit/risk ratio for patients continuing in the trial. An overwhelming 97% of participants were deemed to have a positive benefit/risk ratio and thus continued treatment without the use of standard IPF therapies.

Professor Toby Maher from the Keck School of Medicine at the University of Southern California expressed optimism about the trial results. He highlighted the potential of buloxibutid to halt disease progression, restore lung function, and improve patient outcomes safely and effectively.

Biomarker analyses during the trial showed an increase in plasma levels of MMP-13, a collagenase, and a trend toward decreased plasma levels of the profibrotic cytokine TGFβ1, aligning with the drug’s mechanism of action. These findings suggest that buloxibutid not only improves lung function but might also modify the disease process.

The positive outcomes from the AIR trial have paved the way for Vicore to advance buloxibutid into Phase 2b development, named the ASPIRE trial. This upcoming study will be a randomized, double-blind, placebo-controlled, parallel group, multicenter trial. It will include patients on standard care with nintedanib and those not receiving standard care, with the primary endpoint being the change in FVC over 52 weeks.

Chief Executive Officer of Vicore Pharma, Ahmed Mousa, expressed enthusiasm about the results, stating that they exceeded expectations and reinforce the potential of buloxibutid as a disease-modifying treatment for IPF. He noted the significant improvement in FVC and the biomarker data as strong indicators of the drug's potential impact on the future standard of care for IPF patients.

The results from the AIR trial mark a significant milestone for Vicore, bringing them closer to their goal of providing meaningful, innovative treatment options for IPF, a disease with limited current therapies and significant unmet medical needs. The company is leveraging its expertise in ATRAG chemistry and biology to expand its pipeline with new therapies for respiratory and other diseases.