Vicore Pharma (VICO) investor relations material

Industry landscape and unmet need

• IPF has a three to four-year survival rate, with current drugs only incrementally slowing lung function decline and presenting tolerability challenges.

• Recent entrants like nerandomilast offer better tolerability but not groundbreaking efficacy; inhaled treprostinil shows better efficacy but is harder to tolerate.

• Clinicians are interested in combination therapies and more effective, better-tolerated drugs.

• The disease impacts the alveolar epithelium, interstitium, and vasculature, suggesting multi-compartment targeting may yield better outcomes.

Mechanism of action and preclinical evidence

• The AT2 receptor is targeted to drive tissue repair, resolve fibrosis, and support vasodilation.

• Buloxibutid activates type 2 alveolar epithelial cells, replenishing gas exchange and reversing prefibrotic collapse.

• Preclinical models show buloxibutid protects epithelial cells, increases surfactant protein, reduces TGFβ1 and collagen, and upregulates collagenases.

• The mechanism aims to both halt new fibrosis and resolve existing fibrosis.

Clinical development and trial results

• Phase II-A was a nine-month, open-label study in treatment-naive IPF patients, showing over 200 ml improvement in lung function at 36 weeks.

• The signal is supported by duration, alignment with mechanism, and biomarker trends (decreased TGFβ1, increased MMP-13).

• Geographic distribution (75% India, rest UK) did not affect results; synthetic placebo arm confirmed expected decline in untreated patients.

• Discontinuations were mainly COVID-related; conservative analysis still showed statistically significant benefit.