On February 4, 2013 Promedior, Inc., a clinical stage biotechnology company developing novel biologic therapeutics for the treatment of fibrosis, reported the publication of data from a clinical study of PRM-151 (recombinant human Pentraxin-2 (PTX-2) (Press release, Promedior, FEB 4, 2013, View Source [SID:1234512084]). Published in Pulmonary Pharmacology and Therapeutics and entitled "Recombinant human serum amyloid P in healthy volunteers and patients with pulmonary fibrosis" (PMID: 23380438), the paper presents the final clinical data from a Phase 1a study of PRM-151 that evaluated safety and exploratory biomarker activity in healthy subjects and idiopathic pulmonary IPF patients. Across all study participants, PRM-151 was shown to be generally safe and well tolerated; and in a subset of study participants with IPF, PRM-151 administration resulted in a potentially beneficial impact on correlative biomarkers through reductions in serum IPF-related blood fibrocyte levels.
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"Data from this clinical study support the potential of PRM-151 as a novel targeted therapeutic to treat IPF," said Elizabeth Trehu, M.D., Chief Medical Officer of Promedior. "We look forward to advancing our clinical program to address the significant unmet needs of IPF patients."
This paper analyzed data from a randomized, double blind, placebo controlled study that was initially performed in 26 healthy human volunteers. In the study, single doses of PRM-151 from 0.1mg/kg to 20mg/kg were administered by intravenous infusion. After completion of dosing of healthy volunteers, three patients with idiopathic pulmonary fibrosis were administered a single dose of 10mg/kg intravenously to confirm the safety, pharmacokinetics, and to assess the pharmacodynamic effects of PRM-151 on serum cytokine and fibrocyte biomarkers.
Noteworthy results from the published study included:
· Single doses of PRM-151 up to 20mg/kg were safe and well tolerated in both healthy volunteers and IPF patients.
· There were no dose limiting adverse events, all adverse events were self limiting, and no severe or serious adverse events occurred.
· PRM-151 levels increased dose dependently in healthy volunteers, and PRM-151 administration resulted in a 6- to 13-fold increase in mean baseline plasma SAP levels at dose levels of 5 to 20 mg/kg.
· Analysis of efficacy biomarkers comparing healthy volunteers and IPF patients indicated that PRM-151 administration resulted in a 30-50% decrease in serum fibrocyte numbers 24 hours post-dose. Thus, administration of PRM-151 may be associated with a reduction of fibrocytes in IPF patients.
In late 2012, Promedior announced the completion of a multi-center Phase 1b clinical study of PRM-151 in 21 IPF patients. Data from this Phase 1b clinical study will be presented in an oral session at the 2013 American Thoracic Society Annual Meeting on May 22nd, 2013.
About IPF
IPF is a serious, life-limiting lung disease characterized by fibrosis and scarring of lung tissue. Replacement of normal lung tissue by fibrosis results in restriction in the ability to fill the lungs with air and decreased transfer of oxygen from inhaled air into the bloodstream. This decreased oxygen transfer results in lower oxygen delivery to the brain and other organs, and produces symptoms of shortness of breath, particularly with exertion; chronic, dry, hacking cough; fatigue and weakness, chest discomfort, loss of appetite and rapid weight loss. While estimates vary, it is believed that IPF could affect approximately 130,000 patients in the US and approximately 76,000 patients in Europe.