Promedior received breakthrough therapy designation from FDA for PRM-151 in idiopathic pulmonary fibrosis

Promedior

26 March 2019 - Promedior today announced that PRM-151, a novel investigational anti-fibrotic immunomodulator, has been granted breakthrough therapy designation by the U.S. FDA for idiopathic pulmonary fibrosis. 

Promedior recently announced that it had reached an agreement with the FDA on the design of a Phase 3 registrational study for PRM-151 in idiopathic pulmonary fibrosis using forced vital capacity as a primary endpoint and six-minute walk distance as a key secondary endpoint.

The FDA's decision was informed in part by a Phase 2, randomised, double-blind, trial designed to evaluate the safety and efficacy of PRM-151, a recombinant form of human pentraxin-2 protein, versus placebo in 117 patients with IPF. 79% of the patients received standard of care treatment of either pirfenidone or nintedanib.

Read Promedior press release

Michael Wonder

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Michael Wonder