Drug development company Promedior Inc. recently announced the results of its Phase 1B clinical trial of PRM-15 for treating Idiopathic Pulmonary Fibrosis (IPF). Their findings show that structural and functional imaging of IPF patients correlate with data obtained from standard pulmonary tests. The new data could lead to further development of the therapy as an effective treatment for IPF and its complications.
The company’s results were summarized in a poster presentation entitled, “Structural and Functional Quantitative Imaging Techniques are Complimentary in Retrospective Analysis of PRM-151 Data in Idiopathic Pulmonary Fibrosis (IPF),” which was presented at the 18th International Colloquium on Lung and Airway Fibrosis (ICLAF), held in Mont Tremblant, Quebec, Canada, from 20-24 September 2014.
In Idiopathic Pulmonary Fibrosis, patients suffer from shortness of breath, which ultimately escalates into a life-threatening condition. It is characterized by scarring of the lung tissue and is currently incurable.
PRM-151 is a recombinant form of a human protein, Pentraxin-2 (PTX-2), and was previously demonstrated to exert anti-fibrotic effects on several fibrotic disease models, including pulmonary fibrosis. Now, PRM-151 has been redesigned to both prevent and reverse fibrosis, thus tackling the core of IPF pathology.
In the Phase 1b clinical trial, PRM-151 was administered intravenously to patients at different dosages (1, 5 and 10 mg/kg) over several days (day 1, 3, 5, 8 and 15). The study was performed for 57 days, and the results were evaluated relative to the control-placebo group. Besides safety and tolerability, the study evaluated multiple clinical endpoints — Forced Vital Capacity (FVC), Diffusion Capacity of the Lung for Carbon Monoxide (DLCO), six-minute walk test, quality of life, and biomarker of fibrosis.
In parallel, High Resolution CTs (HRCT) was performed during the Phase 1b to determine lung and lobar volumes. Analysis of these images correlated with the results obtained from standard pulmonary tests, with increasing lung capacity in PRM-151 treated patients and the reverse in placebo-treated patients. Therefore, the authors suggest the use of these imaging techniques as a robust, reliable, and a fast-track method to be used in future PRM-151 clinical trials.