Promedior plans to begin Phase 3 testing of its investigational therapy PRM-151 for the treatment of idiopathic pulmonary fibrosis (IPF), now that the U.S. Food and Drug Administration has signed off on the trial design, the biotechnology company announced.
The agreement was reached in an end-of-Phase-2 meeting between Promedior’s representatives and the FDA to assess and discuss the findings of a Phase 2 trial that evaluated lung function improvement in patients treated with either PRM-151 or a placebo.
Now that the meeting is completed, Promedior expects to start the Phase 3 trial testing the effectiveness of PRM-151 in IPF patients sometime this year.
“Our interactions with the FDA have been collaborative and constructive, and their guidance clearly positions PRM-151 as a Phase 3-ready candidate,” Renu Gupta, MD, chief medical officer of Promedior, said in a press release.
PRM-151 is an engineered form of pentraxin 2, an anti-fibrotic protein that can resolve fibrosis by blocking further inflammation. Lower levels of pentraxin 2 in IPF patients are associated with increased fibrotic damage.
In the 24-week Phase 2 trial (NCT02550873), 117 IPF patients either received an intravenous (into the vein) dose of PRM-151 or a placebo. The team evaluated forced vital capacity (FVC) — the change in the volume of air forcefully expelled — post-treatment as a measure of lung function. They also assessed changes in the six-minute walk distance (6MWD) to determine the ability of the treatment to improve exercise capacity.
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Results showed that lung function decline was significantly reduced in patients treated with PRM-151. In addition, exercise capacity was markedly increased in PRM-151-treated patients, showing they could cover significantly longer distances than those treated with placebo, the researchers reported. PRM-151 was also found to be well-tolerated by the patients.
“The results of the Phase 2 study demonstrated a significant treatment effect for PRM-151 versus placebo in the change of lung function, measured as FVC, and suggest the potential of PRM-151 to stabilize the distance walked over 6 minutes time in patients with IPF over a 28-week period, including those who received combination with standard of care treatment,” said Ganesh Raghu, MD, professor of medicine and director of the Center for Interstitial Lung Diseases, University of Washington in Seattle.
“We look forward to confirming the results of the Phase 2 study of PRM-151 in a larger Phase 3 study and to fully elucidating its disease-modifying potential,” Raghu added.
FVC will be a primary objective and the 6MWD a secondary goal in the new Phase 3 trial.
Promedior will also consult with the European Medicines Agency this year to seek its input on trial design.
Additionally, the company plans to investigate PRM-151 as a potential treatment for other medical conditions affecting the lungs, liver, and kidneys, as well as in cancer.
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