Pliant Therapeutics (PLRX) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Pipeline and clinical development

• Bexotegrast is in a phase IIb/III BEACON-IPF trial, with phase IIb enrollment of 360 patients completing in 1Q 2025 and topline data expected in Q2 2026, ahead of previous guidance; phase III will start after dose selection.

• BEACON-PPF, a pivotal phase IIb trial for progressive pulmonary fibrosis, will initiate in the second half of 2024.

• Over 850 participants have been dosed with bexotegrast, showing favorable safety and tolerability.

• Oncology program PLN-101095 is in phase 1, with interim data from three fully enrolled cohorts expected this quarter and ongoing combination studies with pembrolizumab.

• Additional pipeline asset PLN-101325 is phase 1 ready for muscular dystrophies.

Clinical results and differentiation

• Bexotegrast improves FVC, reverses fibrosis, and reduces cough severity, with unique symptomatic benefit among antifibrotics.

• PET imaging shows reduction in total lung collagen, indicating reversal of fibrosis after 12 weeks.

• Outperforms competitors in FVC improvement and has fewer notable adverse events compared to other investigational and approved drugs.

• Demonstrates significant reduction in pro-fibrotic gene expression in human explant tissue, superior to nerandomilast and admilparant.

• Additive effect on standard of care, with 80% increase in FVC when combined with approved drugs.

Market opportunity and commercial outlook

• Pulmonary fibrosis is a $4B market, projected to reach $6–$10B within 10 years, driven by aging populations and earlier diagnosis.

• Only 25% of diagnosed IPF patients are optimally treated; over 75% are not due to efficacy-safety trade-offs.

• Market growth will be driven by increased treatment rates and longer duration on therapy, potentially doubling market size.

• Bexotegrast targets active switchers, treatment-naive, previously discontinued, and combination therapy patients.

• PPF indication could expand addressable U.S. patient population by ~100,000, significantly increasing commercial potential.