FibroGen to present FG-4592 phase 2a study of patients with stage 3-4 Chronic Kidney Disease and anemia

Nov 19 2010

FibroGen, Inc., today announced that new data from a phase 2a study of patients with stage 3-4 Chronic Kidney Disease and anemia will be presented demonstrating that its first-in-class, investigational oral anemia therapy FG-4592 works differently than erythropoiesis stimulating agents (ESAs) to increase hemoglobin. The results of the study will be presented by lead investigator Anatole Besarab, MD, of Henry Ford Hospital in Detroit, Michigan, in a free communication on Saturday November 20, 2010 at 5:30 in Korbel 4D (Abstract #SA-FC416).

About FG-4592

FG-4592 is a hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) that stabilizes HIF, the key regulatory protein that coordinates all elements of erythropoiesis necessary for proper formation of mature, iron-rich red blood cells plump with oxygen-carrying hemoglobin molecules. Nonclinical and early clinical data suggest that FG-4592 may offer several safety and efficacy advantages over current ESA therapy. Specifically, FG-4592 increases hemoglobin concentration and is expected to do so:

• with levels of circulating endogenous erythropoietin (EPO) within the physiological range in contrast to supraphysiologic EPO levels resulting from treatment with ESAs;
• without increase in blood pressure whereas rates of new or worsening hypertension of 25-40% are described in ESA prescribing information;
• regardless of baseline iron status and without supplemental iron; whereas iron supplementation is required in nearly all ESA-treated patients; and
• in patients who do not respond well to ESA therapy ("hyporesponders"), who, largely due to inflammation, require up to 20 times the ESA dose utilized by the best responding patients.

These potential benefits are being evaluated in ongoing and upcoming clinical trials, and FibroGen has a proprietary position relating to these key concepts.

Global Development of FG-4592

Certain rights to FG-4592 are licensed to Astellas Pharma Inc. for Japan, Europe, Commonwealth of Independent States (CIS), Middle East, and South Africa. As part of this agreement, Astellas pays 50% of development costs for FG-4592 in the US and Europe and milestone payments at certain time points in the program.

FibroGen retains rights to its anemia therapies in North and South America, remaining parts of Africa and all of Asia Pacific ex-Japan. On September 20, 2010, FibroGen announced that FG-4592, received Clinical Trial Application (CTA) approval from the Chinese State Food and Drug Administration (SFDA) to commence Phase 1 and Phase 2 clinical development for the treatment of anemia associated with CKD in the People's Republic of China. Phase 1 trials have commenced in China.

Source: FibroGen, Inc.