A novel treatment for idiopathic pulmonary fibrosis (IPF), PRM-151 (Promedior), has been granted Breakthrough Therapy designation by the Food and Drug Administration (FDA).
PRM-151, a recombinant form of the endogenous human innate immunity protein pentraxin-2 (PTX-2), is an agonist that acts as a macrophage polarization factor to prevent, and potentially reverse, fibrosis. The FDA designation was based on data from a phase 2 trial which evaluated PRM-151 in 117 patients with IPF; the primary efficacy endpoint was the least-squares mean change in forced vital capacity (FVC) percentage of predicted value from baseline at 28 weeks.
Results showed that patients treated with PRM-151 every 4 weeks had a change in FVC percentage of predicted value of -2.5% compared with −4.8% for those treated with placebo (P=.001), indicating a slower decline in lung function with the investigational treatment. In addition, change in 6-minute walk distance (secondary endpoint) was found to be −0.5 meters for patients treated with PRM-151 vs −31.8 meters for those in the placebo group (P<.001).
“[Breakthrough Therapy designation] underscores the disease-modifying potential of PRM-151 in IPF, a serious, life-limiting lung disease for which despite existing therapies, patient prognosis remains poor with a median survival of 3-5 years,” said Jason Lettmann, Chief Executive Officer of Promedior. “Our pivotal program in IPF is designed to show outcomes that could provide meaningful benefit to patients and differentiation in the market over the standard of care.
For more information visit Promedio.com.