Benzinga | Oct 22, 2020 10:18AM EDT

FibroGen Highlights Presentation Of Late-Breaker Abstract Results On Associations Between Hemoglobin Levels, Cardiovascular Outcomes In Roxadustat-Treated Patients With Anemia Of Chronic Kidney Disease

FibroGen, Inc. (NASDAQ:FGEN) today announced results from two analyses of pooled data from the roxadustat global Phase 3 development program, examining associations between the achieved hemoglobin (Hb) levels and cardiovascular outcomes of both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anemia of chronic kidney disease (CKD). Results of the analyses of three trials in NDD patients and three trials in DD patients, respectively, showed that Major Adverse Cardiovascular Events (MACE; all-cause mortality, myocardial infarction, and stroke) and MACE+ (MACE plus heart failure or unstable angina requiring hospitalization) rates were highest when Hb was less than 8 g/dL, decreased as Hb increased, and were lowest when Hb levels were greater than or equal to 10 g/dL.

These data (Abstracts PO2625 and PO2626) were accepted as late-breaking abstracts and will be featured in the Late-Breaking Clinical Trials Posters session at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined on October 22 at 10 AM.

"We have evidence that roxadustat is effective in increasing and maintaining hemoglobin levels in patients with anemia of chronic kidney disease, as shown across the roxadustat clinical program. These new post-hoc analyses showed that for patients who were treated with roxadustat, rates of cardiovascular events were lowest in patients when their hemoglobin levels were greater than 10 g/dL," said Robert Provenzano, MD, Associate Professor of Medicine, Wayne State University, Detroit, Michigan, U.S. and a primary investigator in the roxadustat global Phase 3 program. "These additional safety results, coupled with roxadustat's well-defined efficacy profile and its oral formulation, support the potential for roxadustat to become a safe and effective treatment option for anemia of chronic kidney disease, an area that has seen little therapeutic progress in the last 30 years."

In both analyses, incidence rates of adjudicated MACE and MACE+ were evaluated based on Hb level immediately before the event. In the NDD CKD population, MACE and MACE+ rates were highest when Hb was less than 8 g/dL, decreased as Hb increased and were lowest when achieved Hb levels were greater than or equal to 10 g/dL.

Parameter Maximum Hemoglobin < 8 8 - < 9 9 - < 10 10 - < 11 11 - < 12 ? 12 g/dL g/dL g/dL g/dL g/dL g/dLOutcome Time point Event rate/100 PEY (95% CI) MACE Immediately 60.9 25.6 16.2 7.1 4.9 6.7 before event MACE+ Immediately 82.9 35.0 21.5 10.4 6.8 9.7 before event PEY 59.1 179.9 501.4 1189.8 1417.4 690.0

PEY: patient-exposure years

Similarly, in the DD CKD population, MACE and MACE+ rates were highest when Hb was less than 8 g/dL, decreased as Hb increased and were lowest when achieved Hb levels were greater than or equal to 10 g/dL.

Parameter Maximum Hemoglobin < 8 g/dL 8 - < 9 9 - < 10 10 - < 11 11 - < 12 ? 12 g/dL g/dL g/dL g/dL g/dLOutcome Time point Event rate/100 PEY (95% CI) MACE Immediately 59.4 23.0 17.4 10.6 9.4 7.2 before event MACE+ Immediately 65.7 29.9 25.2 13.5 11.5 9.8 before event PEY 63.9 173.8 464.7 1055.1 1149.8 539.4

PEY: patient-exposure years

"Anemia typically develops in patients with chronic kidney disease and worsens as the disease progresses, decreasing oxygenation and resulting in an increased risk of cardiovascular complications and death," said Peony Yu, M.D., Chief Medical Officer, FibroGen. "We are delighted to be presenting these additional results that further demonstrate the potential of roxadustat to be a meaningful treatment option for chronic kidney disease patients with anemia."