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Pliant Receives Orphan Drug Designation for PSC, IPF Drug
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Pliant Therapeutics received an FDA orphan drug designation for PLN-74809, an anti-fibrotic compound for treating primary sclerosing cholangitis, according to a press release.
“Our excitement for lead product candidate PLN-74809 continues to build as we have now received orphan drug designation in both PSC and idiopathic pulmonary fibrosis (IPF),” Éric Lefebvre, MD, chief medical officer of Pliant Therapeutics, said in the release. “We expect to initiate our first clinical trial to support our lead indication of IPF before year-end, followed by studies in PSC to further investigate our approach of inhibiting integrins as a way to impact key drivers of fibrosis.”
PLN-74809 also received FDA orphan drug designation for IPF in August 2019.
“Achieving this important regulatory milestone provides Pliant an early vote of confidence as we prepare our investigational new drug application and plan the first-in-human trials for PLN-74809,” Lefebvre said in a press release regarding its designation for IPF. “We are eager to initiate clinical development of this product candidate early next year as a potential treatment option for patients with IPF.”
Reference: www.pliantrx.com