Vicore Pharma's novel angiotensin II type 2 receptor agonist, buloxibutid, has demonstrated the ability to not only stabilize but improve lung function in patients with idiopathic pulmonary fibrosis (IPF), according to data from the company's Phase 2a AIR trial.
The oral therapy showed an average forced vital capacity (FVC) increase of 216ml from baseline across 36 weeks of treatment. This improvement stands in stark contrast to the typical disease progression, where untreated IPF patients would experience an approximate 180ml decline in lung function over the same period.
"In the previously disclosed interim results of the Phase 2a AIR trial, buloxibutid demonstrated the ability to stabilize and subsequently improve lung function as measured by forced vital capacity, in individuals with the life-shortening disease, idiopathic pulmonary fibrosis," said Toby Maher, MD, Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California.
The drug was well-tolerated throughout the 26-week treatment period, with no new drug-related adverse events reported, suggesting a favorable safety profile alongside its efficacy signals.
Comprehensive Data Presentation at ATS 2024
Vicore will present the final data from the Phase 2a AIR trial as a late-breaking presentation at the 2024 American Thoracic Society (ATS) International Conference in San Diego on May 19. This presentation will include complete data from all patients treated for up to 36 weeks.
"We are pleased to showcase a series of presentations at the upcoming ATS International Conference," said Ahmed Mousa, Chief Executive Officer of Vicore Pharma. "In addition to the final Phase 2a AIR data, these presentations will highlight the power of our upstream tissue repair mechanism and provide further details on our planned Phase 2b ASPIRE trial of buloxibutid in IPF."
The company has scheduled multiple presentations at the conference, including:
- A late-breaking oral presentation titled "Buloxibutid, a Novel Angiotensin II Type 2 Receptor Agonist, Stabilized and Improved Lung Function in Individuals with Idiopathic Pulmonary Fibrosis in the 36-week Phase 2 AIR Trial" on May 19
- A poster discussion on "Deciphering the Clinical Efficacy Mechanisms of Buloxibutid in Idiopathic Pulmonary Fibrosis" on May 20
- A thematic poster presentation on "Crafting a Patient-focused Phase 2b Trial (ASPIRE) to Evaluate Efficacy and Safety of Buloxibutid in Individuals with Idiopathic Pulmonary Fibrosis (IPF)" on May 20
Additionally, Vicore will be featured at the ATS 2024 Respiratory Innovation Summit on May 17, where they will present a poster outlining the role of angiotensin II type 2 receptor agonism in IPF and the clinical development program for buloxibutid.
IPF Treatment Landscape and Unmet Need
IPF is a rare, chronic, and progressive lung disease affecting up to 20 people per 100,000 globally. The condition causes the lungs to thicken and stiffen, resulting in permanent fibrosis and breathing difficulties. Current standard-of-care therapies can slow the decline of lung function but cannot reverse or halt disease progression.
The potential disease-modifying approach of buloxibutid represents a significant advancement in the IPF treatment landscape. By targeting the angiotensin II type 2 receptor, the drug appears to activate tissue repair mechanisms that could potentially reverse some of the damage caused by the disease.
Future Development Plans
Following the promising Phase 2a results, Vicore is advancing buloxibutid to a Phase 2b ASPIRE trial, which will investigate FVC changes over 52 weeks. This larger study will provide more comprehensive data on the drug's long-term efficacy and safety profile.
The development of buloxibutid comes at a time when another experimental therapy, Endeavor BioMedicines' ENV-101, has also shown promise in treating IPF. ENV-101, a hedgehog signaling pathway inhibitor, demonstrated a statistically significant increase in total lung capacity above baseline at 12 weeks in a separate Phase 2a trial.
These emerging therapies represent potential breakthroughs in IPF treatment, offering hope for a disease-modifying approach to a condition with limited therapeutic options and poor prognosis.
