What Is PBI-4050?
Phase I study of this drug involving 40 healthy volunteers was concluded in 2014. The study showed that PBI-4050 was safe and well-tolerated in all 40 participants with no adverse events being reported. After the Phase I study, both the US FDA and the European Commission have granted PBI-4050 orphan drug designation as a potential IPF treatment in 2015.
The Phase II study of this drug concluded earlier in 2017. The patient characteristics at baseline were similar to those trials for pirfenidone (Esbriet) and ninfedanib (Ofev). Outcomes from this study demonstrated promising results that PBI-4050 can be a safe and effective treatment for IPF and the results were presented at the 2017 American Thoracic Society (ATS) International Conference. The company have been approved and is expected to start two Phase 2/3 placebo-controlled studies in the second half of 2017. The first one is for IPF patients to take PBI-4050 or placebo in combination with nintedanib (Ofev). The second study is for IPF patients who have failed both pirfenidone (Esbriet) and nintedanib (Ofev) to take PBI-4050 as the lone therapy.