Pliant Therapeutics (PLRX) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Pipeline overview and clinical progress

• Four clinical programs are underway, with bexotegrast as the lead candidate for IPF and PSC, both in phase IIa and IIb/III trials.

• The BEACON-IPF study is a seamless phase IIb/III registrational trial, expected to complete enrollment by Q1 next year, with data anticipated mid-2026.

• Early-stage programs include an oncology integrin inhibitor in phase I, with data expected late this year or early next year.

• A DMD program has CTA approval and is ready for phase I entry pending completion of preclinical work.

Seamless phase IIb/III trial design and regulatory strategy

• The seamless design eliminates the gap between phase IIb and III, potentially saving two years to phase III data and NDA submission.

• Most global regions are participating under the seamless protocol, expediting timelines; ongoing engagement with the FDA continues for U.S. inclusion.

• The phase IIb is treated as a pivotal study, using absolute change in FVC at 52 weeks as the primary endpoint, powered at 80%.

• Two independent, confirmatory studies are conducted within the seamless design, which could serve for the NDA package.

• Phase IIb results will inform dose and sample size for phase III, with total patient numbers expected to align with traditional IPF studies.

Dose selection and safety profile

• The 320 mg dose of bexotegrast is a strong candidate for phase III, but 160 mg is also included due to favorable results across endpoints.

• At least 30% of BEACON patients will not be on background therapies, allowing assessment of monotherapy efficacy.

• Over 700 patients have been treated with bexotegrast, showing a clean safety profile with no dose-related adverse events.