FDA grants Angion Biomedica's BB3 therapeutic Fast Track and Orphan Drug product designations

Jul 7 2010

Angion Biomedica Corp., a biopharmaceutical company dedicated to the discovery and development of novel therapeutics that enhance quality of life, eradicate disease and save lives by modulating the body's protective, reparative and regenerative systems, announced today that its lead therapeutic BB3 was accepted into the Fast Track program of the U.S. Food and Drug Administration (FDA) and has also been designated an Orphan Drug product by FDA. Angion Biomedica is pursuing BB3 for the treatment of renal transplantation and acute renal failure and the drug is currently in Phase 2 clinical trials.

"Successful clinical development of BB3 has the potential to greatly increase the number of renal transplants by permitting use of kidneys that are currently discarded as well as to improve function and graft survival of suboptimal transplanted kidneys," said Itzhak D. Goldberg, MD, FACR, Angion Biomedica's CEO. "The FDA's recognition of BB3 as both a Fast Track program candidate and an Orphan Drug product will greatly facilitate the development of Angion Biomedica's key program from a timing and economic standpoint." Angion Biomedica is also actively developing BB3 for treatment of non-renal acute and chronic organ injuries.

Numerous and diverse pathological mechanisms, such as infection, inflammation, and toxic or ischemic injury, can lead to organ dysfunction and failure, hampering quality of life and impacting survival. During the disease process, excessive production of extracellular matrix, a process called fibrosis, transforms healthy cells and organs into non-functional scar tissue. For example, chronic liver disease from hepatitis infection or alcohol damage; lung damage from smoking or from unknown causes (idiopathic pulmonary fibrosis); and kidney damage or failure secondary to diabetes or following transplantation, represent different routes to common end organ damage and ultimately failure. However, these organs possess common protective, reparative and regenerative mechanisms that can be harnessed to improve function. Angion Biomedica seeks to identify and develop modulators of these pathways to block pathology and restore organ function. BB3 is an activator of the pathway induced by interaction of hepatocyte growth factor (HGF) and its receptor, a kinase that triggers a powerful reparative response. Angion Biomedica's earlier stage programs are investigating modulators of other kinases, as well as of the PARP and retinoic acid pathways.

The FDA's Fast Track designation recognizes the need for expedited regulatory review of drugs to treat serious diseases and to fill unmet medical needs. The FDA's orphan drug product program recognizes the economic hardship of developing drugs to treat diseases of low prevalence, and offers assistance in regulatory development and economic incentives once a drug is approved.

SOURCE Angion Biomedica Corp.