Vicore Pharma (VICO) Stifel 2026 Virtual Immunology and Inflammation Forum summary

Industry landscape and unmet needs

• Recent advances in IPF drug development have generated optimism after years of failures, with better tolerability seen as a key driver for new therapies.

• Current therapies like nintedanib offer limited effect size and significant tolerability issues, especially in combination regimens.

• There remains a large unmet need for well-tolerated drugs with meaningful efficacy, as IPF continues to be a fatal disease.

• Combination therapy is desirable, but existing drugs are poorly tolerated together, highlighting the need for new options.

Buloxibutid mechanism and preclinical data

• Buloxibutid is an oral angiotensin II type 2 receptor agonist targeting upstream mechanisms in IPF pathogenesis.

• The drug acts on type II alveolar cells, aiming to restore their function and reduce fibrosis.

• Preclinical studies show increased surfactant protein D, reduced TGF-beta and collagen, and improved vascular health.

• Buloxibutid restores matrix metalloproteinase activity, aiding collagen breakdown, with supportive clinical biomarker data.

Phase II-A AIR study results

• The AIR study was a single-arm, open-label trial in treatment-naïve IPF patients, focusing on safety and efficacy.

• Buloxibutid was well-tolerated, with minimal GI side effects and only mild hair thinning in about 10% of patients.

• Patients completing 36 weeks showed a mean FVC increase of 216 ml, an unprecedented result in IPF.

• Sensitivity analyses using external control cohorts showed the probability of such improvement by chance is extremely low (P=0.0025).

• Biomarker data, including increased MMP-13 and reduced TGF-beta, support the drug's mechanism and potential for reversing early disease abnormalities.