Pliant Therapeutics, Inc. is a biopharmaceutical company in the clinical development stage, dedicated to discovering, advancing, and bringing to market innovative therapies for fibrotic and related diseases across the United States. Its flagship investigational product, PLN-74809, is an orally administered, small-molecule, dual-selective inhibitor targeting both avß6 and avß1 integrins, which is currently progressing through three distinct Phase 2a clinical trials. The company's pipeline also includes PLN-1474, a small-molecule selective inhibitor of avß1, which has successfully completed its Phase 1 clinical assessment for treating liver fibrosis associated with nonalcoholic steatohepatitis (NASH). Furthermore, Pliant is nurturing two additional integrin-based initiatives in preclinical development: one focused on oncology, and another involving an allosteric agonistic monoclonal antibody designed to act upon an undisclosed integrin receptor for the treatment of various muscular dystrophies, including Duchenne muscular dystrophy. Founded in 2015, Pliant Therapeutics, Inc. maintains its corporate headquarters in South San Francisco, California.
Pliant Therapeutics Receives FDA Fast Track Designation for PLN-101095 in Combination with Pembrolizumab for the Treatment of ICI-Refractory Solid Tumors
Pliant Therapeutics received FDA Fast Track designation for PLN-101095 in combination with pembrolizumab for the treatment of solid tumors resistant to immune checkpoint inhibitors.
The designation is designed to expedite the development and review of the drug, providing opportunities for frequent FDA meetings and eligibility for priority review and rolling submissions.
PLN-101095 is currently being evaluated in the Phase 1a/1b FORTIFY trial, with data expected in 2027.