Pliant Therapeutics (PLRX) Piper Sandler 36th Annual Healthcare Conference summary

Key milestones and study progress

• BEACON-IPF study enrollment is on track for completion in Q1 2025, with a global patient base across North America, Latin America, Europe, and Asia.

• Top-line data from the study is expected by mid-2026, with main results to be communicated at readout.

• The study uses a seamless design outside the U.S., integrating phase 2b and phase 3 components for operational efficiency.

• Cash runway stands at $406 million, funding operations through 2026.

Study design and endpoints

• Patients are stratified by use of background therapies (pirfenidone or nintedanib) to ensure balanced treatment groups and avoid confounding efficacy factors.

• The primary endpoint is a statistically significant difference in FVC decline between active and placebo groups, with the study powered at 80%.

• A reduction in FVC decline greater than 50% over 52 weeks, with good safety and low discontinuation, is considered a meaningful advance.

• Subgroup analyses will focus on patients not on background therapy, representing at least 30% of the population.

Biomarkers and additional measures

• Biomarkers such as PRO-C3 and QLF (quantitative lung fibrosis) are being measured to assess anti-fibrotic activity.

• QLF is used in all major phase 3 studies and a 2% change is considered clinically meaningful.

• Collagen PET studies have shown the drug can reduce type 1 collagen in the lung over 12 weeks.