Phase 2 clinical trial of PBI-4050 in patients with idiopathic pulmonary fibrosis
| Autor: | John E. Moran, Gary R. Albert, Lyne Gagnon, Nasreen Khalil, Martin Kolb, Frank Cesari, Joseph M. Parker, Christopher J. Ryerson, Renata Sawtell, Paul Hernandez, Aline Hagerimana, Pierre Laurin, Eric Turcotte, Shane Shapera, Hélène Manganas, André M. Cantin |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Pulmonary and Respiratory Medicine
medicine.medical_specialty Phases of clinical research Interstitial Lung Diseases Gastroenterology 03 medical and health sciences FEV1/FVC ratio Idiopathic pulmonary fibrosis chemistry.chemical_compound 0302 clinical medicine Pharmacokinetics Fibrosis Internal medicine medicine 030212 general & internal medicine business.industry Pirfenidone Original Articles medicine.disease Clinical trial 030228 respiratory system chemistry Nintedanib business medicine.drug |
| Zdroj: | The European Respiratory Journal |
| ISSN: | 1399-3003 0903-1936 |
| Popis: | PBI-4050 is a novel orally active small-molecule compound with demonstrated anti-fibrotic activity in several models of fibrosis, including lung fibrosis. We present results from our first clinical study of PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF). This 12-week open-label study explored the safety, efficacy and pharmacokinetics of daily oral doses of 800 mg PBI-4050 alone and in combination with nintedanib or pirfenidone in patients with predominantly mild or moderate IPF. Nine patients received PBI-4050 alone, 16 patients received PBI-4050 with nintedanib and 16 patients received PBI-4050 with pirfenidone. PBI-4050 alone or in combination with nintedanib or pirfenidone was well tolerated. Pharmacokinetic profiles for PBI-4050 were similar in the PBI-4050 alone and PBI-4050+nintedanib groups but reduced in the PBI-4050+pirfenidone group, suggesting a drug–drug interaction. There were no significant changes in forced vital capacity (FVC), either in % predicted or mL, from baseline to week 12 for PBI-4050 alone or PBI-4050+nintedanib. In contrast, a statistically significant reduction (p PBI-4050 alone and in combination with nintedanib demonstrated no safety concerns and showed encouraging results for lung function in IPF patients http://ow.ly/olQD30myD0E |
| Databáze: | OpenAIRE |
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