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LEXINGTON, Mass.--(BUSINESS WIRE)-- Promedior, Inc., a clinical stage biotechnology company developing novel biologic therapeutics for the treatment of fibrosis, unveiled data from a clinical study of PRM-151 in an oral presentation at the 2013 American Thoracic Society (ATS) International Conference in Philadelphia. The clinical data from a randomized, double-blind, placebo controlled Phase 1b multiple ascending dose study showed that PRM-151 was generally safe and well tolerated in patients with idiopathic pulmonary fibrosis (IPF). In addition, the study showed encouraging results in exploratory efficacy endpoints.
"We are excited to present data from this clinical study, which underscore the safety and potential of PRM-151 as a novel therapeutic to treat IPF, a serious and life threatening orphan fibrotic disease,” said Beth Trehu, MD, FACP, Chief Medical Officer. "The safety profile and intriguing efficacy signals seen in this Phase 1b multiple dose trial of PRM-151 in patients with IPF support advancement of this clinical program to Phase 2. We are also initiating clinical development of PRM-151 in myelofibrosis, another serious and life threatening orphan fibrotic disease.”
The oral presentation at ATS 2013 showed data from a randomized, double blind, placebo controlled study that was performed in 21 patients with IPF. In the study, PRM-151 doses of 1, 5 and 10 mg/kg or placebo were administered intravenously on days 1, 3, 5, 8 and 15. Patients were followed for 57 days after receiving their first dose. This Phase 1b clinical study’s primary endpoint was safety and tolerability, and PRM-151 was shown to be generally safe and well tolerated across all study participants, with no serious adverse events. Additionally, the clinical study measured exploratory clinical endpoints, including Forced Vital Capacity (FVC), Diffusion Capacity of the Lung for Carbon Monoxide (DLCO), six minute walk test, quality of life, and several biomarkers of fibrosis.
Noteworthy results from this clinical study included:
• Doses of PRM-151 up to 10mg/kg were safe and well tolerated in IPF patients.
• There were no dose limiting adverse events, all adverse events were mild or moderate, and no serious adverse events were observed. No acute infusion-related adverse events were reported.
• IPF patients who received PRM-151 showed a measurable increase in lung function from baseline, as quantified by percent predicted FVC at 8 weeks. The percent predicted FVC for patients dosed with PRM-151 showed a mean increase from baseline of 2.4 percent at 8 weeks; in contrast, patients who received placebo had a mean 1.5 percent decrease from baseline. Percent predicted FVC increased by 10 percent from baseline in three of the 14 patients receiving PRM-151, and by 5 percent in three additional patients receiving PRM-151.
• Mean total distance walked in the 6 minute walk test increased by 8 meters in PRM-151 treated patients and declined by 10.5 meters in placebo patients.
• Mean DLCO decreased by 1.79 percent in PRM-151 treated patients and by 2.33 percent from baseline in placebo patients.
• The intriguing exploratory efficacy results recapitulate preclinical data of PRM-151 in a lung fibrosis model, in which rapid and durable reduction in fibrosis was accompanied by improvement in lung function.1
PRM-151, Promedior’s lead product, is a recombinant form of an endogenous human protein, Pentraxin-2 (PTX-2), that is specifically active at the site of tissue damage. PRM-151 is an agonist that acts as a macrophage differentiation factor to prevent and potentially reverse fibrosis. PRM-151 has shown broad anti-fibrotic activity in multiple preclinical models of fibrotic disease, including pulmonary fibrosis, acute and chronic nephropathy, liver fibrosis, and age-related macular degeneration.
Promedior has been granted Orphan Drug Designation for PRM-151 in IPF by the FDA in the United States and by the European Commission. A Phase 2 study in myelofibrosis patients is planned for initiation later this year.
About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a serious, life-threatening lung disease characterized by fibrosis and scarring of the lung tissue. Replacement of normal lung tissue by scar tissue 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 US2 and approximately 76,000 patients in Europe.3 There is no curative therapy, and the only treatment that results in significant improvement is lung transplant.
Promedior is a clinical stage biotechnology company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis is a harmful process that occurs in many diseases, when normal healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Promedior's proprietary platform is based upon Pentraxin-2, an endogenous human protein that is specifically active at the site of tissue damage and works as an agonist, potentially preventing and reversing fibrosis.
Promedior has successfully advanced their lead therapeutic candidate in human clinical trials, and is initially focused on rare fibrotic diseases, including idiopathic pulmonary fibrosis (IPF) and myelofibrosis. Promedior is backed by leading global healthcare venture investors, has a significant intellectual property estate relating to the discoveries and applications of Pentraxin-2 therapeutics and is led by an experienced management team. For additional information about Promedior, please visit www.promedior.com.
1 Pilling et al. 2007 J. Immunol. 179: 4035-4044
2 Raghu, G., et al. “Incidence and prevalence of idiopathic pulmonary fibrosis. ” Am. J. Respir. Crit. Care Med. 2006. 174(7): 810-816
3 European Medicines Agency. “Positive Opinion on orphan designation for recombinant human pentraxin-2 in idiopathic pulmonary fibrosis” , July 17, 2012 (http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/08/human_orphan_001096.jsp&mid=WC0b01ac058001d12b)
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