Vicore Pharma Completes ASPIRE Trial Enrollment in IPF

Stockholm, Sweden – April 22, 2026

In a significant advancement for respiratory therapeutics, Vicore Pharma has announced the successful completion of patient enrollment in its Phase 2b ASPIRE clinical trial evaluating buloxibutid, a novel treatment candidate for idiopathic pulmonary fibrosis (IPF). This milestone highlights strong global clinical execution and growing momentum in the development of disease-modifying therapies for fibrotic lung diseases, an area with substantial unmet medical need.

Global Trial Execution and Strong Patient Recruitment

The ASPIRE trial, a randomized, placebo-controlled Phase 2b study, successfully enrolled over 360 patients across more than 100 clinical sites in 14 countries, including extensive participation from the United States. This rapid enrollment, completed ahead of expectations, reflects robust investigator engagement and increasing interest in innovative therapies targeting IPF.

The study is designed to evaluate the impact of buloxibutid, an angiotensin II type 2 receptor agonist (ATRAG), on forced vital capacity (FVC) over a 52-week period—the gold-standard regulatory endpoint in IPF trials. The drug is administered in two dosing regimens, both as monotherapy and in combination with existing standard-of-care treatments, ensuring comprehensive evaluation across patient populations.

This milestone underscores the company’s operational efficiency and the urgent demand for next-generation pulmonary therapies, particularly in diseases where current treatment options remain limited in both efficacy and tolerability.

Addressing the Unmet Need in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis is a progressive and fatal fibrotic lung disorder affecting approximately 3 million people globally, with a median survival of only 3–5 years post-diagnosis. Existing antifibrotic therapies provide only modest slowing of lung function decline, and many patients discontinue treatment due to adverse effects or limited benefits.

The investigational drug buloxibutid represents a first-in-class oral small molecule therapy with disease-modifying potential, aiming to improve lung function and slow disease progression more effectively than current standards. Earlier data from the Phase 2a AIR trial demonstrated encouraging improvements in FVC over 36 weeks, supporting advancement into the larger ASPIRE trial.

Experts in the field have emphasized the importance of such innovations, noting that IPF continues to present significant clinical challenges, and novel mechanisms like ATRAGs may redefine treatment paradigms in fibrotic diseases.

Clinical Outlook and Future Milestones

With enrollment now complete, Vicore Pharma is shifting focus toward data generation and analysis, with topline results expected in mid-2027. The company has also confirmed a financial runway extending into the second half of 2028, ensuring continued support for the clinical program and potential next-phase development.

The ASPIRE trial includes key secondary endpoints such as safety, tolerability, and disease progression rates, which will provide a comprehensive understanding of buloxibutid’s therapeutic profile. If successful, the drug could advance into late-stage clinical development, positioning it as a potential breakthrough therapy in pulmonary fibrosis.

Additionally, buloxibutid has already received Orphan Drug and Fast Track designations from the U.S. FDA, signaling regulatory recognition of its potential to address a critical unmet medical need.

This development marks a crucial step forward in the global effort to combat IPF and reinforces Vicore Pharma’s role as a key innovator in fibrotic disease therapeutics.

Source: Vicore Pharma press release