Phase 2 Clinical Trial Begins for PRM-151 in Patients with Idiopathic Pulmonary Fibrosis
http://ab166704.adbutler-zilon.com/redirect.spark?setID=183805&channelID=0&CID=102465&banID=519314022&tc=1&plid=415591&location=http%3A%2F%2Fpulmonaryhypertensionnews.com%2Fclinical%2Dtrials%2F Promedior recently announced the initiation of a Phase 2 trial of PRM-151 http://pulmonaryfibrosisnews.com/prm-151-idiopathic-pulmonary-fibrosis/, an experimental anti-fibrotic agent, in patients with Idiopathic Pulmonary Fibrosis (IPF). Previous clinical Phase 1 studies also conducted by Promedior, a biotechnology company working on therapeutics for the treatment of fibrosis, led to this placebo-controlled Phase 2 study, which is designed to determine the efficacy and safety of PRM-151 in approximately 117 patients with IPF.
“We are thrilled to initiate our Phase 2 study in IPF, which is based on the Phase 1b clinical data that was presented in an oral session at the American Thoracic Society 2013 Annual Meeting and a poster at the International Colloquium on Interstitial Lung Diseases in 2014,” said Elizabeth G. Trehu, Chief Medical Officer of Promedior in a news release http://www.businesswire.com/news/home/20150908005590/en/Promedior-Announces-Initiation-Phase-2-Clinical-. “We are investigating PRM-151’s novel mechanism of action in a larger and more robust trial to determine if PRM-151 will make a meaningful difference to patients with IPF.”
IPF is a life-threatening lung disease usually affecting middle-aged and older adults, characterized by fibrosis and scarring of the lung tissue. As a result, lungs are unable to transfer oxygen from inhaled air into the bloodstream. IPF has no cure and available treatments only reduce the symptoms. “Despite the recent approval of two new therapies for IPF, there is still a great need for a treatment that reverses lung fibrosis and improves pulmonary function,” said Ganesh Raghu, co-Principal Investigator of this Phase 2 study.
PRM-151 is a recombinant human serum protein, Pentraxin-2 (PTX-2), specifically active at the site of tissue damage targeting the underlying fibrotic pathology of IPF. After a placebo controlled Phase 1b trial tested different doses of PRM-151 in patients with IPF, Promedior has designed this Phase 2 trial to advance the therapy into safety and efficacy testing.
“I am very enthusiastic about this Phase 2 trial,” said Bernt van den Blink, Principal Investigator of the Phase 1b study of PRM-151 in IPF and co-Principal Investigator of the current study. “I am delighted to have enrolled the first patient in this important study.”
The Phase 2 trial is planned for test centers in the US, UK, Netherlands, Belgium, Spain, Germany, the Czech Republic, Hungary, and Poland. The trial will be randomized for patients receiving PRM-151 or placebo and double-blinded to determine the effect of PRM-151 relative to placebo. Lung function will be assessed by pulmonary function tests including forced vital capacity, high-resolution chest computed tomography, six minute walk test, and patient reported outcomes. Safety will be evaluated by adverse events, physical exam, clinical labs and IPF related mortality. All patients will be offered the opportunity to receive PRM-151 after 24 weeks in an open label extension study.
For further information about this clinical trial, please visit www.clinicaltrials.gov https://www.clinicaltrials.gov/.
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