Patients with idiopathic pulmonary fibrosis treated with a recombinant human pentraxin 2 protein exhibited sustained reductions in decline of FVC and 6-minute walking distance at 76 weeks, according to data published in The Lancet Respiratory Medicine. The data come from a 76-week open-label extension study. The new results are consistent with those observed during the 28-week, double-blind period.
PRM-151 (Promedior) acts as a macrophage polarization factor to prevent and potentially reverse fibrosis, according to a company press release. The extension study included 111 patients, of which 37 patients previously assigned placebo crossed over to the treatment arm. Eighty-four patients (76%) received concomitant IPF therapy with pirfenidone (n = 55; Esbriet, Genentech) or nintedanib (n = 29; Ofev, Boehringer Ingelheim).
At week 76, the observed mean changes in FVC were 191.7 mL in those who continued on PRM-151 vs. 213.1 mL in those who crossed over to the treatment arm.
The observed mean changes in 6-minute walking distance at week 76 were 5.9 m in those who continued on PRM-151 and 35.2 m in those who crossed over to the treatment arm, which corresponds to an overall benefit of 29.3 m with PRM-151.
The rates of treatment-related adverse events were consistent with long-term IPF sequelae.
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In an accompanying editorial, Demosthenes Bouros and colleagues highlighted the need for continued data on this novel agent. “The safety and efficacy signals emerging from the randomized controlled trial and the extension study … justify the need for larger phase 3 trials. Application of an oncological approach with personalized medicine strategies seems to be the only way forward,”