Item 8.01 Other Events.
On January 22, 2023, Pliant Therapeutics, Inc. (the "Company") announced 12-week
interim data from the 320 mg dose group of INTEGRIS-IPF, a multinational,
randomized, double-blind, placebo-controlled Phase 2a clinical trial of
bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis ("IPF").
The 320 mg group met its primary and secondary endpoints demonstrating that
bexotegrast was well tolerated over a 12-week treatment period and displayed a
favorable pharmacokinetic profile. The trial's exploratory efficacy endpoints
assessed changes in forced vital capacity ("FVC"), Quantitative Lung Fibrosis
("QLF") imaging and biomarkers. Bexotegrast at 320 mg demonstrated a
statistically significant mean increase in FVC from baseline at all timepoints,
surpassing all lower dose cohorts, and showed a strong treatment effect on FVC
percent predicted, QLF and profibrotic biomarkers versus placebo at 12 weeks. A
copy of the Company's press release, titled "Pliant Therapeutics Announces
Positive Data from the INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast 320
mg was Well Tolerated and Achieved Statistically Significant FVC Increase in
Patients with Idiopathic Pulmonary Fibrosis," is attached as Exhibit 99.1 to
this Current Report and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Description
99.1 Press Release, dated January 22, 2023, titled "Pliant Therapeutics
Announces Positive Data from the INTEGRIS-IPF Phase 2a Trial
Demonstrating Bexotegrast 320 mg was Well Tolerated and Achieved
Statistically Significant FVC Increase in Patients with Idiopathic
Pulmonary Fibrosis."
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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