FibroGen, Inc. on Nov. 17th announced encouraging results of a small early stage study of FG-3019, a fully human monoclonal antibody for use in treating connective tissue growth factor (CTGF) in people with diabetes and microalbuminuria (the earliest clinical sign of diabetic nephropathy).

The data from the phase Ib study was presented at Renal Week 2006, the annual meeting of the American Society of Nephrology (ASN), by Dr. Sharon G. Adler of the UCLA School of Medicine.

In the study, the urinary albumin to creatinine ratio (ACR), an early marker of kidney disease, decreased by 50 percent or more in 7 of 19 subjects (including 6 of 13 patients who enrolled in the study with microalbuminuria).

"The finding that ACR significantly declined in microalbuminuric patients after only two months of treatment with FG-3019 exceeded our expectations," said Adler.

"These data support longer-term studies of FG-3019 in diabetic patients with more advanced kidney disease where the development of a safe and effective therapy that significantly delays or halts progression to renal failure is greatly needed," she added.

"We look forward to initiating longer-term, controlled studies in patients with diabetic nephropathy where higher CTGF levels have been strongly associated with progression of renal and cardiovascular disease," said Thomas B. Neff, Chief Executive Officer at FibroGen.

Results also demonstrated that FG-3019 was well tolerated. Only one serious adverse event was reported, which was considered unrelated to study drug. No dose-limiting toxicities were observed.