- Pliant Therapeutics Inc (NASDAQ:PLRX) says that with just two FDA-approved Idiopathic Pulmonary Fibrosis drugs, it believes that is a high unmet need.
- Roche Holdings AG's (OTC:RHHBY) Esbriet and Boehringer Ingelheim's Ofev have around $4 billion combined U.S. sales. However, both drugs have modest efficacy (FVC), do not affect survival, have tolerability issues, and have low persistence rates (~30%).
- PLRX believes PLN-74809 can improve upon existing therapies across efficacy and safety/tolerability profile.
- Topline results from the Phase 2a INTEGRIS-IPF trial are expected in mid-2022. The primary endpoints are safety/tolerability, but key efficacy measures are QLF and FVC.
- Related: Pliant Stock Moves Higher On Positive Data From Pulmonary Fibrosis Trial.
- PLRX believes a 2% change in QLF corresponds to a ~10% change in FVC, which is clinically meaningful.
- A separate Phase 2 trial of 320mg PLN-74809 is underway to accumulate safety data to justify 320mg dose inclusion in the potential Phase 2b dose-ranging trial.
- Regarding the potential development path forward in IPF, the management says it would pursue the Phase 2b/Phase 3 'seamless' design but acknowledges the lack of precedent.
- Initial results from PLN-74809 Primary Sclerosing Cholangitis (PSC) program are expected in 4Q FY22/1Q FY23.
- Price Action: PLRX shares are up 10% at $7.56 during the market session on the last check Wednesday.
