Biopharmaceutical company FibroGen (FGEN 49.50, +16.10 +48.2%) last night announced positive topline results from its Phase 2 randomized, double-blind, placebo-controlled study and two combination safety sub-studies of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) and released Q2 earnings, sending the stock to all-time highs above the $51 level.
Pamrevlumab is a proprietary, first-in-class, anti-connective tissue growth factor (CTGF) antibody being evaluated in fibrotic disease and cancer.
As mentioned, FGEN announced positive topline results from its Phase 2 randomized, double-blind, placebo-controlled study and two combination safety sub-studies of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
In the double-blind, placebo-controlled portion of this study, 103 patients were randomized (1:1) to receive either pamrevlumab or placebo for 48 weeks. Pamrevlumab met the primary efficacy endpoint of change of forced vital capacity percent predicted (FVC % predicted), a measure of change in lung volume, from baseline to week 48 of the study:
- Statistical significance was demonstrated using a linear slope analysis in the intent to treat population:
- Average decline in FVC % predicted from baseline to week 48 was 2.85 in the pamrevlumab arm as compared to an average decline of 7.17 in the placebo arm, an absolute difference of 4.33.
- Pamrevlumab-treated patients had an average decrease in FVC of 129 ml at week 48 compared to an average decrease of 308 ml in patients receiving placebo.
- Consistent with previous clinical studies, pamrevlumab was well tolerated in IPF patients.
In the double-blind, active-controlled combination sub-studies, 57 patients were randomized to assess the safety of combining pamrevlumab with approved IPF therapies. Thirty-six (36) patients on a stable dose of pirfenidone were randomized 2:1 to also receive pamrevlumab or placebo for 24 weeks. Twenty-one (21) patients on a stable dose of nintedanib were randomized 2:1 to also receive pamrevlumab or placebo for 24 weeks. Pamrevlumab was well tolerated when administered in combination with either pirfenidone or nintedanib.
Further, FGEN reported Q2 results. The net loss per diluted share was $0.48 while total revenues for the period fell about 68% compared to a year ago to about $29.0 million.
The market potential alone seems to be the driving force behind FGEN’s move today as the Street reflects on the value of the anti-fibrotic compound. FGEN will also present additional results at the upcoming 2017 European Respiratory Society International Congress in September.