Pliant Therapeutics has initiated the Phase IIb BEACON-IPF clinical trial of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (IPF).
The dose-ranging, placebo-controlled, double-blind, multinational, randomised study will evaluate 160mg or 320mg doses of bexotegrast in patients with IPF.
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It will enrol nearly 270 patients from worldwide sites. They will receive the treatment for a period of 52 weeks.
Assessment of the change from baseline in absolute forced vital capacity (FVC) mL at week 52 is the primary endpoint of the study.
Secondary endpoints of the trial include the evaluation of safety, tolerability, change from baseline in patient-reported measurements of symptoms, and well-being at week 52.
Measurement of time to disease progression and change from baseline in absolute FVC (ml) on or not on background therapies are other secondary endpoints.
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By GlobalDataPliant Therapeutics chief medical officer Éric Lefebvre said: “With the start of BEACON-IPF, we are achieving an important company milestone and taking a step forward to potentially bringing this novel drug candidate to patients.
“BEACON-IPF follows the positive results from our Phase IIa INTEGRIS-IPF trial demonstrating bexotegrast was well tolerated and demonstrated encouraging preliminary patient benefits for those both on and off current background therapies.
“We look forward to advancing this trial to further our understanding of bexotegrast as a potential therapy in the treatment of IPF.”
Bexotegrast is the company’s lead product candidate and is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins.
It has also received orphan drug designation from the European Medicines Agency and both fast-track and orphan drug designations from the US Food and Drug Administration for treating IPF and primary sclerosing cholangitis (PSC).
The company has also initiated other clinical-stage programmes for treating nonalcoholic steatohepatitis and solid tumours.
