A Phase 2 trial testing the investigational therapy pamrevlumab (FG-3019) in patients with idiopathic pulmonary fibrosis (IPF) has shown positive and encouraging results, FibroGen, the drug’s developer, announced.
These results will be presented at the European Respiratory Society International Congress, taking place in Milan, Italy, Sept. 9-13.
Pamrevlumab is a fully human monoclonal antibody targeting the connective tissue growth factor (CTGF), a critical molecule mediating progression of fibrosis.
The Phase 2 study (NCT01890265) enrolled 103 patients who were assigned randomly to receive either pamrevlumab or placebo (control) during a 48-week period.
Pamrevlumab successfully reached the study’s primary endpoint – change in forced vital capacity percent predicted (FVC% predicted) from baseline to week 48. FVC% predicted, a measure of lung function, is a parameter that measures changes in lung volume, indicating the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Specifically, the results showed that while the average decline in FVC% predicted from baseline to week 48 was of 7.17 in the placebo control group, in patients treated with pamrevlumab this was only 2.85. Moreover, the average decrease in FVC was 129 ml and 308 ml at week 48, for pamrevlumab-treated and placebo, respectively. The differences found between placebo and pamrevlumab all were statistically significant.
In agreement with findings from previous studies, pamrevlumab was found to be well-tolerated.
“I am pleased to see positive Phase 2 results with pamrevlumab — an antibody against CTGF, a new target in fibrosis — which has a good safety profile and the potential to provide alternative, much-needed new treatment options for IPF patients,” said Luca Richeldi, MD, PhD, in a press release. Richeldi is head of the Division of Pulmonary Medicine at Agostino Gemelli University Hospital of the Catholic University of the Sacred Heart in Rome.
In another study, researchers investigated the safety of combining pamrevlumab with approved IPF therapies – Esbriet and Ofev. In a group of 36 patients undergoing treatment with Esbriet, patients were randomly assigned to also receive pamrevlumab or placebo for 24 weeks. In another arm of the study, 21 patients receiving a stable dose of Ofev were randomized to receive pamrevlumab or placebo for the same period (24 weeks).
The results showed that combining pamrevlumab with either Esbriet or Ofev poses no risk for IPF patients.
“The positive results from this randomized placebo-controlled Phase 2 study build on our previous clinical data which demonstrated the potential of pamrevlumab to slow the progression of IPF with a good safety and tolerability profile,” said Peony Yu, MD, FibroGen’s chief medical officer.
“We are conducting further analyses and look forward to presenting additional data from this study in the months ahead. We believe these results support a Phase 3 program in patients suffering from this debilitating and deadly disease,” Yu concluded.