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FibroGen Announces Positive Topline Results from Phase 2 Study of Pamrevlumab in Idiopathic Pulmonary Fibrosis

Meets Primary Endpoint with Statistical Significance

Management to discuss results on today’s quarterly financial results conference call

SAN FRANCISCO, Aug. 07, 2017 (GLOBE NEWSWIRE) -- FibroGen, Inc. (FGEN), a science-based biopharmaceutical company, announced today positive topline results from the company’s Phase 2 randomized, double-blind, placebo-controlled study and two combination safety sub-studies of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF). Pamrevlumab is a proprietary, first-in-class, anti-connective tissue growth factor (CTGF) antibody being evaluated in fibrotic disease and cancer.

“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, M.D., Ph.D., Head of the Division of Pulmonary Medicine at Agostino Gemelli University Hospital of the Catholic University of the Sacred Heart in Rome, Italy.

In the double-blind, placebo-controlled portion of this study, one hundred-three (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, fifty-seven (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.

“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...