RARE Daily

Pliant Raises $230 Million in Public Offering to Advance Pipeline of Fibrosis Therapies

July 18, 2022

Just days after announcing positive data from a mid-stage trial of its experimental therapy PLN-74809 in patients with idiopathic pulmonary fibrosis, Pliant Therapeutics closed an upsized underwritten public offering of 12.4 million shares of its common stock at $18.50 per share, raising $230.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Pliant.

Pliant intends to use the net proceeds from the offering to develop its ongoing and future preclinical and clinical programs including PLN-74809, further develop its integrin targeting platform, to fund working capital, operating expenses and capital expenditures, and for other general corporate purposes.

Idiopathic pulmonary fibrosis (IPF) is a rare, chronic, progressive, fibrosing lung disease of unknown cause with few treatment options and a poor prognosis. Patients experience debilitating symptoms, including shortness of breath and difficulty performing daily activities, such as walking and talking. Currently, there is no pharmacological cure for IPF with neither of the approved two therapies demonstrating an ability to stop the progression of IPF, leaving a high unmet need for new therapeutic options to address the symptoms and modify disease progression.

Pliant’s lead product candidate, PLN-74809, is an oral small molecule dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis (IPF), and primary sclerosing cholangitis (PSC). PLN-74809 has received Fast Track designation and Orphan Drug designation from the U.S. Food and Drug Administration in IPF and Orphan Drug designation from the FDA and European Medicines Agency in PSC.

Pliant reported positive data from INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled phase 2a clinical trial of PLN-74809 in patients with IPF, which met its primary and secondary endpoints demonstrating that PLN-74809 was well tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile. The trial’s exploratory efficacy endpoints assessing changes in forced vital capacity (FVC) and Quantitative Lung Fibrosis (QLF) imaging, demonstrated a dose-dependent treatment effect on FVC and QLF versus placebo over 12 weeks in PLN-74809 treated patients.

The study evaluated PLN-74809 at once-daily doses of 40 mg, 80 mg, 160 mg, or placebo for 12 weeks in 90 patients with IPF. A total of 67 patients were enrolled in the active arms and 23 patients were enrolled in the placebo arm. Approximately 80 percent of enrolled patients were on standard of care and were equally distributed between nintedanib and pirfenidone.

The primary endpoint of the INTEGRIS-IPF trial is the evaluation of the safety and tolerability of PLN-74809. The secondary endpoint is an assessment of its pharmacokinetics.

PLN-74809 was well tolerated at all three doses tested. Of the 67 patients treated with PLN-74809, 65 (97 percent) completed 12 weeks of treatment with no discontinuations due to adverse events. No deaths or drug-related serious adverse events (SAE) were reported. Most treatment emergent adverse events were mild or moderate in severity.

Author: Rare Daily Staff

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